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A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Blood Lactate Analysis Adult patients 18 years or older Admitted to the Intensive Care Unit (ICU) Determined by their treating clinicians to require both a central venous line and arterial line | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Coronary Artery Disease Coronary Sinus Circulation, Collateral Ischemia Collateral Flow Index Age > 17 years Stable angina pectoris, patient electively referred for coronary angiography Written informed consent to participate in the study Acute coronary syndrome; unstable cardio-pulmonary conditions Congestive heart failure NYHA III-IV Previous coronary bypass surgery Q-wave myocardial infarction in the area undergoing CFI measurement Anatomical variants not allowing coronary sinus occlusion Severe valvular heart disease Severe hepatic or renal failure (creatinine clearance < 15ml/min) Pregnancy | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Patients less than 18 years of age Patients who are unable or unwilling to give full informed consent Pregnancy Significant upper limb peripheral arterial disease Patients on glibenclamide or nicorandil (these medications may interfere with remote ischaemic preconditioning) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a history of myocarditis, pericarditis or amyloidosis Patients undergoing Fenestrated or branched EVAR | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Bypass Complications Disorder of Blood Gas age > 18 years old undergoing totally thoracoscopic cardiac surgery with cardiopulmonary bypass without informed consent pregnancy | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 17.0-999.0, Contrast Induced Nephropathy Remote Ischaemic Preconditioning Hospital inpatients undergoing contrast enhanced abdomino-pelvic CT scanning Those with an allergy/hypersensitivity to the contrast solution Those with a Cr of above 150μmol/dL on admission, as is a contraindication to IV contrast Patients who are not getting IV contrast Any patients with a history of renal transplantation Any patients with a history of previous acute kidney injury necessitating management by a nephrologist Patients taking either a sulphonlurea or nicorandil | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Sleep Apnea Register to the social health insurance Referred for a walk test because of claudication Maximal walking ditance < 750m Older than 18 years old Able to understand the protocol of the study Cardiac insufficiency already known, stage III or IV i.e. dyspnea at rest Unstable angina or myocardial infarction within the previous three months Severe reparatory disease already known Parkinson disease, hémiplégia ou paraplégia Does not want to participate to the protocol Pregnant women Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research Being in a period of from another biomedical study | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 50.0-999.0, Osteoarthritis Cardiovascular Risk Factors Cardiovascular Disease Metabolic Syndrome Patients referred for symptomatic hand or knee osteoarthritis All patients referred in the same period for soft tissue disease > 50 years old Any other rheumatologic condition secondary osteoarthritis | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Peripheral Arterial Disease a positive history of chronic claudication exercise-limiting claudication established by history and direct observation during a screening walking test administered by the evaluating vascular surgeon an ankle/brachial index < 0.90 at rest absence of Peripheral Arterial Disease (PAD) acute lower extremity ischemic event secondary to thromboembolic disease or acute trauma exercise capacity limited by conditions other than claudication including leg (joint/musculoskeletal, neurologic) and systemic (heart, lung disease) pathology | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 20.0-75.0, High Risk Cardiovascular Disease Patients high risk hypertension patients a. eGFR > 60 with one of target organ damages b. eGFR <= 60 diabetes mellitus with microalbumin ration (AC ratio >= 30mg/g) anuric ESRD patients on dialysis the relatives of acute myocardial infarction patients under 55 years old (men)/ 65 years old (women) acute myocardial infarction, acute coronary syndrome patients, symptomatic coronary artery disease or history of these diseases symptomatic peripheral artery disease, heart failure and history of these diseases desired life time under 6 months due to non-cardiovascular disease (e.g. cancer, sepsis) women with pregnancy or on nursing history of contrast allergy and related side effects | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease Critical Limb Ischemia Intermittent Claudication All adults > 18 years old willing to be randomized Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications Acute thromboembolic disease in the leg Infrainguinal aneurysmal disease Previous participation in the study or in other randomised interventional study of infrainguinal lesions Patients without a Swedish personal identification number | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-65.0, Hypertension The final selection of the sample of 80 patients diagnosed with stage I arterial hypertension will be based on the ABPM results (24h SBP/DBP ≥ 130/80 mm Hg) Patients who present with normal ABPM values at the end of the 3-month period will be excluded from the study. Subjects diagnosed with white-coat hypertension [increased office BP values (SBP/DBP ≥ 140/90 mm Hg) combined with normal ABPM values (24h SBP/DBP < 130/80 mm Hg)] will also be excluded from the study All subjects with contra-indications for submission of drugs used in the research protocol are going to be excluded from the study. The following categories of patients will not participate in the research: renal failure, hepatic failure, renal artery stenosis, bronchial asthma, vasoconstrictive (Prinzmetal's) angina, hypertrophic cardiomyopathy, aortic valve stenosis, mitral valve stenosis, sinus tachycardia, sinus bradycardia, sick sinus syndrome, Wolff-Parkinson-White syndrome, chronic atrial fibrillation, second and third degree atrioventricular block, right heart failure due to pulmonary hypertension, pheochromocytoma, peripheral artery disease. Pregnant and nursing women will be excluded from the study (history and pregnancy test) | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Abdominal Aortic Aneurysm Carotid Atherosclerosis Critical Lower Limb Ischaemia Age greater than 18 years Patient willing to give full informed consent for participation Patients undergoing elective carotid endarterectomy or Patients undergoing open abdominal aortic aneurysm repair or Patients undergoing endovascular abdominal aneurysm repair or Patients undergoing surgical lower limb revascularisation (suprainguinal or infrainguinal) Pregnancy Significant upper limb peripheral arterial disease Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with a known history of myocarditis, pericarditis or amyloidosis Patients with an estimated pre-operative glomerular filtration rate < 30mls/min/1.73m2 Patients with severe hepatic disease defined as an international normalised ratio >2 in the absence of systemic anticoagulation Patients with severe respiratory disease (for the trial, defined as patients requiring home oxygen therapy) Patients previously enrolled in the trial representing for a further procedure Patients with previous axillary surgery | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Peripheral Arterial Disease, Rutherford Stage 4 and 5 With the Possibility to Improve Vascularization. Patients with peripheral arterial disease Rutherford stage 4 and 5, where it is possible to improve the vascularization of the affected leg with the help of an endovascular and / or open surgical vascular intervention Patients with both legs are affected, but the most severe leg does not exceed stage 5 Severe cardiopulmonary comorbidity (NYHA 4) and previous amputations of lower leg or thigh Patients with limited amputation of the toes can participate Insufficient understanding of the Dutch language No physiotherapy insurance | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-80.0, ST-Segment Elevation Myocardial Infarction Male or non-pregnant female Age ≥ 18 years old and ＜80 years old Consecutive patients who should be hospitalized with documented evidence of ST-Segment Elevation Myocardial Infarction receiving Percutaneous Coronary Intervention All patients havepersistent≥0.2 Millivolt ST segment elevation in two or more contiguous precordial leads or ≥0.1 Millivolt ST elevation in two or more contiguous limb leads, with one of the following: persistent chest pain or elevatory of biomarkers of myocardial necrosis Time from chest pain onset to receiving Percutaneous Coronary Intervention <12 hours Persistent chest pain <12 hours Provision of informed consent prior to any study specific procedures Involved in other trials In recent one year have P 2 Y 12 receptor antagonist drug treatment history or long-term use of immunosuppressive agents Recurrent myocardial infarction or previous history of Coronary Artery Bypass Graft(CABG) surgery or rescue Percutaneous Coronary Intervention Active bleeding or bleeding history With obvious infection and body temperature (axillary temperature) higher than 38.0 ℃ Autoimmune diseases Malignancies In recent 6 months have received major surgery Left ventricular ejection fraction is less than 30% Life expectancy less than one year | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-75.0, Dilated Cardiomyopathy established diagnosis of non-ischemic dilated cardiomyopathy EF < 35% NYHA f.c. II Optimal medical management > 6 months Age < 75 years and > 18 years known hypersensitivity to the medication age > 75 years or < 18 years EF > 35% renal insufficiency (GF < 30) liver dysfunction (liver tests > 3x the upper normal limit)) LQT syndrome drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.) dementia active hemathological or malignant disease | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-90.0, Peripheral Arterial Disease General Signed informed consent At least 18 years old Documented symptomatic iliac, femoropopliteal (FP) or below-the knee artery (BTK) atherosclerotic disease (Rutherford/Becker category 2, 3 or ≥4) Undergone clinically indicated uncomplicated endovascular intervention to one or more locations of the iliac, femoropopliteal below-the knee arteries Estimated survival ≥1 year in the judgment of the primary operator Pre-index procedure use of ASA, clopidogrel or both at any dose Angiographic De novo or restenotic lesions in the common and/or external iliac artery, superficial femoral artery (SFA), popliteal artery, tibio-peroneal (TP) trunk, anterior tibial (AT) artery, peroneal artery (PA) or posterior tibial (PT) artery (applies to all target lesions if multiple) Subjects with multiple planned procedures can be enrolled after the completion of the last planned procedure.- General Complicated qualifying procedure (perforation, flow limiting dissection, distal embolization requiring re-intervention, need for repeat endovascular, surgical revascularization, amputation or blood transfusion prior to hospital discharge following an index procedure Extended hospital stay >7 days following the index procedure Allergy to aspirin or clopidogrel MI or percutaneous coronary intervention with drug eluting stents within the past 9 months Life expectancy less than 12 months due to other medical co-morbid condition(s) that could limit the subject's ability to participate in the trial, limit the subject's compliance with the follow-up requirements, or impact the scientific integrity of the trial Known hypersensitivity or contraindication to contrast dye that, in the opinion of the investigator, cannot be adequately pre-medicated Intolerance to antiplatelet, anticoagulant, or thrombolytic medications Platelet count <90,000 mm3 or >600,000 mm3 Serum creatinine >2.5 mg/dL | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 0.0-999.0, Peripheral Arterial Disease (PAD) Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries | 2 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Arterial Diseases Known moderate PVD New claudication patient with Rutherford stage 2 and Fontaine stage 2a symptoms Known upper limb PVD Severe cardiac condition Risk classification for exercise training: class C and above Severe respiratory condition Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil May affect RIPC Raynaud's Disease Contra indications for MRA Pregnancy | 2 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Vascular Diseases Patients planned for lower limb Angioplasty Known upper limb PVD Previous history of upper limb deep vein thrombosis Patients on glibenclamide or nicorandil May affect RIPC Raynaud's Disease Intra operative decision to use graft will be documented | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-75.0, Painful Diabetic Neuropathy Diabetic Neuropathy, Painful Age ≥ 18 years to 75 years Documented history of Type I or II diabetes with current treatment control (glycosylated hemoglobin A1c of ≤ 10.0% at Screening) and currently on oral medication and / or insulin No significant changes anticipated in diabetes medication regimen No new symptoms associated with diabetes within the last 3 months prior to study entry Diagnosis of painful diabetic peripheral neuropathy in both lower extremities Lower extremity pain for at least 6 months Visual analog scale (VAS) score of ≥ 40 mm at Initial Screening (0 mm = no pain mm very severe pain) Symptoms from the Brief Pain Neuropathy Screening (BPNS) is ≤ 5 point difference between legs at Initial Screening The average daily pain intensity score of the Daily Pain and Sleep Interference Diary completed after medication wash-out is ≥ 4 with a standard deviation ≤ 2 Peripheral neuropathy caused by condition other than diabetes Other pain more severe than neuropathic pain that would prevent assessment of DPN Progressive or degenerative neurological disorder Myopathy Inflammatory disorder of the blood vessels (inflammatory angiopathy, such as Buerger's disease) Active infection Chronic inflammatory disease (e.g., Crohn's disease, rheumatoid arthritis) Positive HIV or HTLV at Screening Active Hepatitis B or C as determined by Hepatitis B core antibody (HBcAb), antibody to Hepatitis B surface antigen (IgG and IgM; HBsAb), Hepatitis B surface antigen (HBsAg) and Hepatitis C antibodies (Anti-HCV) at Screening Subjects with known immunosuppression or currently receiving immunosuppressive drugs, chemotherapy or radiation therapy | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 50.0-999.0, Myocardial Ischemia Surgery written informed consent intermedial and high risk non cardiac surgery general anesthesia ongoing or recently suspended antiplatelet therapy pregnancy planned locoregional anesthesia without general anesthesia unstable or ongoing angina recent (< 1 month) or ongoing acute myocardial infarction in other randomised controlled studies in the previous 30 days peripheral vascular disease affecting the upper limbs cardiac surgery | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Peripheral Arterial Disease Venous Insufficiency Patient suffering from a PAD (systolic pressure index ≥ 0,60 and ≤ 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification Age over 18 years French health insurance Signed informed consent Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI) Diabetes Mediacalcosis (SPI not computable) Inflammatory arterial diseases of the lower limb Permanent edema, lipedema and lymphedema Wound and fragile skin Phlegmatia coerulea dolens Septic thrombophlebitis Severe coronary artery disease Oozing and infectious skin diseases, skin ulcers | 1 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Congenital Heart Disease Male or Female over 18 years of age Moderate or Complex Congenital Heart Disease Willingness to Consent Pregnancy Surgery within 6 months Unrepaired cyanotic heart disease Patients with Eisenmenger Syndrome physiology | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 18.0-999.0, Intermittent Claudication Peripheral Vascular Disease All ethnic groups, male or female above the age of 18 years Diagnosis of mild intermittent claudication Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device Blood pressure currently under moderate control (< 160/100mmHg) No current foot ulceration Patients meeting any of the following are to be excluded Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol Has diabetes Ankle Brachial Pressure Index > 0.9 Has any metal implants Pregnant Has a cardiac pacemaker or defibrillator device Has recent lower limb injury or lower back pain Has current foot ulceration or other skin ulcers Has foot deformities | 0 |
A 72-year-old man complains of increasing calf pain when walking uphill. The symptoms have gradually increased over the past 3 months. The patient had an uncomplicated myocardial infarction 2 years earlier and a transient ischemic attack 6 months ago. Over the past month, his blood pressure has worsened despite previous control with diltiazem, hydrochlorothiazide, and propranolol. His is currently taking isosorbide dinitrate, hydrochlorothiazide, and aspirin. On physical examination, his blood pressure is 151/91 mm Hg, and his pulse is 67/min. There is a right carotid bruit. His lower extremities are slightly cool to the touch and have diminished pulses at the dorsalis pedis. | eligible ages (years): 21.0-999.0, Remote Ischaemic Preconditioning Contrast Induced Nephropathy Elective intra-arterial peripheral angiography/angioplasty Patients >21 years of age Patients with CKD as evidenced by eGFR levels of 30ml/min < eGFR < 60ml/min (moderate risk) or eGFR levels of >= 60ml/min (low risk) Severe renal impairment eGFR <30ml/min Evidence of acute renal failure or patients on dialysis History of previous CIN Contraindication to volume replacement therapy Pregnancy Patients on glibenclamide or nicorandil (these medications may interfere with RIPC) | 1 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 4.0-12.0, Obsessive-Compulsive Disorder OCD Participants (N = 72) Aged 4-12 years and living within a four-hour commute from NIH Currently meet DSM-IV for OCD Recent onset of symptoms (less than 6 months.) Healthy Controls (N = 60-72) Age and sex matched to ODC participants Must be free of current or past psychopathology OCD Participants Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever Significant or unstable medical illness Full scale IQ less than 80 Healthy Controls Full scale IQ less than 80 Significant or unstable medical illness | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-999.0, Coronary Arteriosclerosis Adults older than 21 years Coronary artery disease established by angiography No myocardial infarction within 1 month Left ventricular ejection fraction greater than 30% No congestive heart failure symptoms within 2 months No medical condition that might prohibit safe participation in cardiac rehabilitation Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography Angina pectoris that is prolonged in duration (greater than 20 minutes), or does not respond to nitroglycerin (2 tablets) Subject physically unable to perform cardiac rehabilitation protocol due to neurologic or orthopedic conditions Hypersensitivity to organic nitrates Women of childbearing age unless recent pregnancy test is negative Lactating women Known hypersensitivity to dipyridamole or to gadolinium if patient eligible for MRI study | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.5-12.0, Pharyngitis Give informed consent, assent, and documentation of patient authorization for disclosure of study results Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian Age > = 6 months -12 years A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following Tonsillar or pharyngeal exudate Tender cervical lymph nodes Fever or history of fever treated with antipyretics Odynophagia Uvular edema Pharyngeal Erythema of moderate or greater intensity Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology The need for hospitalization or I.V. antimicrobial therapy Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials Patients who are known carriers of S. pyogenes Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 4.0-16.0, Kawasaki Disease Males or females between 4 and 16 Meet the epidemiological definition of Kawasaki Disease or have a diagnosis of incomplete KD, including evidence of coronary artery disease as determined by their physician Be able to exercise adequately to achieve 85% age predicted maximum heart rate Terminal illness where expected survival is < 6 months | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 5.0-16.0, Learning Disorders Child Behavior Disorders DSM-IV Axis II diagnosis of mental retardation behavioural and family therapy tried for 6 months but has failed in school, at least part time score of >=8 on hostility scale subject is otherwise healthy Patients with a seizure disorder requiring repeated change of medication extrapyramidal symptoms not well controlled by medication abnormal and clinically significant electrocardiogram (ECG) changes history of tardive dyskinesia (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs), or neuroleptic malignant syndrome (a rare condition in patients receiving antipsychotic medication in which patients may develop fever, sweating, unstable blood pressure, rigid muscles, and other symptoms, including changes in their normal mental state) known hypersensitivity to antipsychotic medications, including risperidone | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-18.0, Kawasaki Disease To be eligible for the trial, subjects must meet all of the following All eligible subjects, or legal representative, must provide written informed consent/assent, prior to initiation of any study procedure Eligible subjects will be infants and children, under 18 years old, with acute KD who remain or become febrile (>/= 38.3˚ C or 101.0˚ F) after the end of the 48 h-period after completing their IVIG infusion (2gm/kg) Patients must have persistent or reoccurrence of fever > 48 hours of observation to be eligible for the trial Prior to the initial IVIG treatment, patients must have been febrile for >/= 3 days and have met 4/5 standard clinical (Table 1) patients with fever and 3/5 clinical will be eligible if echocardiogram demonstrates at least one coronary artery segment with a Z score of > 2 Patients must present for their initial diagnosis and IVIG treatment within the first 14 days after fever onset (Illness Day 14) Females of childbearing potential and males must be using adequate contraception (abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) throughout the trial All eligible subjects must have a chest radiograph within one week prior to first infusion of study drug with no evidence of malignancy, infection or fibrosis If a subject has any of the following he or she may not be enrolled in the study Have been receiving corticosteroids (ie, via any route) at doses > 1 mg/kg prednisone equivalent daily Have history of TB or TB exposure Have history of histoplasmosis or coccidiomycosis Have received anakinra (Kineret®), etanercept (Enbrel®), or adalimumab (Humira®) within 1 month prior to first study drug administration Have any chronic disease, except asthma, atopic dermatitis or controlled seizure disorder Have documented history of current active hepatitis B or a history of hepatitis C infection Have documented history of human immunodeficiency virus (HIV) infection Have received a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study drug administration) Have a known malignancy or history of malignancy within the 5-year period prior to first study drug administration (with the exception of squamous or basal cell carcinoma of the skin that has been completely excised without evidence of recurrence) | 2 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 8.0-25.0, Kawasaki Disease History of Kawasaki disease more than 12 months before enrollment Present age of 8 years or older Diabetes mellitus Not controlled hypertension Treatment with drugs thay modify endothelial function such as angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, and calcium channel blockers Smokers of more than 5 cigarettes per day Total cholesterol higher than 250 mg/dl Triglycerides higher than 300mg/dl Chronic treatment with statins Chronic renal insufficiency (creatinine > 1.5 mg/dl) | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-90.0, Burn Ages 0-90 years Any patient admitted to the hospital with burn injury requiring grafting and a donor site Patient with severe burn injuries expected to die | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-50.0, Allergic Rhinitis Ability to understand and provide informed consent Male or Female (non-pregnant), age 18-50 Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using a medically acceptable form of birth control throughout the duration of the study Clinical history of seasonal or perennial allergic rhinitis for at least two years, with or without mild persistent asthma Positive puncture skin test greater than or equal to 5 mm diluent control Positive CAP-RAST to Fel d 1 > 0.35 kU/L Positive intranasal cat allergen challenge as defined by > 5 sneezes or a tripling of measured nasal lavage mediators In vitro assay of basophil responsiveness to cat allergen with greater than 20% histamine release The use of antihistamines, cromolyns, leukotriene modifiers and other non-steroid (astelin and topical decongestants), nasal medications will be allowed, but they will be withheld for 5 days prior to each nasal allergen provocation session. Inhaled corticosteroids for mild asthma will be permissible No known contraindications to therapy with omalizumab Asthma with FEV1 < 80%, moderate to severe asthma classification per NAEP Standards (1997 National Asthma Education and Prevention Program Expert Panel Report II guidelines) Serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded Unexplained elevation of ESR, hematocrit < 32%, WBC count 2400/microliter lower limit of normal, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or AST > 100 IU/L Body weight less than 30 kg or greater than 150 kg will be excluded Plans to become pregnant or breastfeed will be excluded from the study A perforated nasal septum, structural nasal defect, large nasal polyps causing obstruction, evidence of acute or chronic sinusitis A life expectancy less than 6 months A terminal illness as determined by the investigator A history of malignancy, anaphylaxis or bleeding disorder are also illnesses Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 2.0-12.0, Tonsillitis Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) and in accordance with local guidelines Patients eligible to anti-TNF therapy Patients naïve to anti-TNFa drugs Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method [Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form Patients with tumors Patients already included in clinical trials | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.167-20.0, Mucocutaneous Lymph Node Syndrome Kawasaki Disease Male Age 2 months to 20 years of age Female Age 2 months to 11 years of age Provision of Parental Consent Kawasaki Disease Presentation Laboratory Any laboratory toxicity, at the time of the screening visit or at any time during the study that in the opinion of the Investigator would preclude participation in the study or Platelet count < 100,000/mm3 WBC count < 3,000 cells/mm3 Hemoglobin, hematocrit, or red blood cell count outside 30% of the upper or lower limits of normal for the Lab Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit Female subjects diagnosed with KD 12 years of age and older Subjects who have known hypersensitivity to Enbrel or any of its components or who is known to have antibodies to etanercept Prior or concurrent cyclophosphamide therapy Prior treatment with any TNF alpha antagonist or steroid within 48 hours prior to initiation of IVIG Concurrent sulfasalazine therapy | 2 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-999.0, Hypertension Hypertensive patients who have never taken Micombi Tablets | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 50.0-999.0, Hypercholesterolemia Type 2 Diabetes Hypertension Patients meeting the following will be included in the study Patients giving voluntary written consent to participate in the study Male or female patients 50 years of age or older (at informed consent) Hypercholesterolemia patients (Untreated patients: LDL-C level ≥140 mg/dL; treated patients: LDL-C level ≥120 mg/dL) Type 2 diabetes patients (HbA1c level ≥6.1% (JDS criteria), with or without history of drug therapy) Hypertension patients (SBP ≥130 mmHg or DBP ≥80 mmHg, with or without history of drug therapy) Patients with two or more of the following risk factors Male years of age or older Smoker Patients meeting the following will be excluded from the study Patients receiving rosuvastatin, pitavastatin, or atorvastatin therapy within one month prior to informed consent Patients judged to have familial hypercholesterolemia Patients with a serum triglyceride level of ≥400 mg/dL Patients with a history of myocardial infarction Patients with a history of coronary revascularization (PCI or CABG) Patients with a history of treatment of unstable angina Patients with a history of cerebrovascular accident (excluding asymptomatic lacunar infarction) Heart failure patients Patients with a history of hypersensitivity to statins | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-999.0, Psoriatic Arthritis Males or females, aged ≥ 18 years at time of consent Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs) May not have axial involvement alone Concurrent Tx allowed with methotrexate, leflunomide, or sulfasalazine Have ≥ 3 swollen AND ≥ 3 tender joints Males & Females must use contraception Stable dose of NSAIDs, narcotics and low dose oral corticosteroids allowed Have at least one ≥2 cm psoriasis lesion Pregnant or breast feeding History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.5-11.0, Rhinitis Perennial Aged 6 months through 11 years Patients with perennial allergic rhinitis Neither serum specific IgE antibody or skin reaction is positive for the antigen of perennial allergy Nasal symptom score is 0 for either sneezing or nasal discharge, or sum of these two score is less than 3, or nasal congestion score is 4 Patients with vasomotor rhinitis or eosinophilic rhinitis | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 4.0-13.0, Obsessive-Complusive Disorder Children Anxiety Disorder Autoimmune Disease PANDAS Male and female children 4-13 years of age Presence of (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision) DSM-IV TR OCD with or without a tic disorder Moderate or greater severity of symptoms, with a score of greater than or equal to 20 on the Children s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and greater than or equal to 4 on the Clinical Global Impression Severity scale (CGI-S) The acute onset within the previous six months of symptoms in a child previously well, or the first acute recurrence within the previous six months, after a period of relatively complete remission of symptoms. The acuity of symptom onset/exacerbation is key and must be severe, dramatic in onset, and proceed from no/minimal symptoms to maximum severity within 24-48 hours Symptom onset or first exacerbation preceded within four months by a GAS infection, as documented by positive throat culture, exposure to documented GAS infection (in a close contact, such as a sibling sharing a bedroom), and/or documented two-fold rise in one or more anti-GAS antibody titers such as anti-streptolysin O, anti-streptococcal DNAaseB, anti-carbohydrate antibodies and others Onset/exacerbation of OCD is accompanied by at least three of the following 7 clinical signs and symptoms. The acuity of the comorbid symptoms must be similar to the OCD symptoms and occur in the same time interval Markedly increased level of anxiety, particularly new onset of separation anxiety Emotional lability, irritability, aggressive behavior and/or personality change Sudden difficulties with concentration or learning Developmental regression ("baby-talk," temper tantrums; behaviors atypical for actual chronological age) History of rheumatic fever, including Sydenham chorea (the neurologic manifestation) Presence of symptoms consistent with autism, schizophrenia, or other psychotic disorder (unless psychotic symptoms have onset coincident with the possible and are attributed to OCD) Presence of a neurological disorder other than a tic disorder IQ < 70. Child subjects need to be able to contribute meaningfully to baseline and follow-up ratings, to report adverse effects, and to assent to participation Presence of serious or unstable medical illness or psychiatric or behavioral symptoms that would make participation unsafe or study procedures too difficult to tolerate IgA deficiency (< 20mg/dL). Intravenous immunoglobulin may contain trace IgA, which may very rarely lead to life-threatening anaphylaxis in IgA-deficient participants with anti-IgA antibodies (Misbah 1993) Hyperviscosity syndromes, which can increase risks associated with IVIG administration Need for live virus vaccine within six months after receiving IVIG (which may be 7.5 months from randomization) since IVIG can interfere with effectiveness of such vaccines. IVIG should not be administered sooner than two weeks after administration of a live virus vaccine, for the same reason Taking nephrotoxic drugs. Every concomitant medication will be subject to scrutiny and possible consultation with pediatric safety monitors before randomization to study drug. See below as well Recent (less than eight weeks) initiation of cognitive-behavior therapy (CBT) | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-999.0, Psoriatic Arthritis Subjects must satisfy the following to be enrolled in the study Male or female, aged ≥ 18 years at time of consent Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted Able to adhere to the study visit schedule and other protocol requirements Have a documented diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 3 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) for PsA at time of screening Have ≥ 3 swollen AND ≥ 3 tender joints Have not been previously treated with disease-modifying antirheumatic drugs (DMARDS) (small molecules or biologics) Be receiving treatment on an outpatient basis If taking oral corticosteroids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 1 month prior to screening History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Clinically significant abnormality on 12-lead electrocardiography (ECG) at Screening Pregnant or breast feeding History of allergy to any component of the IP Hepatitis B surface antigen positive at screening Hepatitis C antibody positive at screening AST/SGOT and/or ALT/SGPT > 1.5 x ULN and total bilirubin > ULN or albumin < lower limit of normal (LLN) History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease) Active tuberculosis or a history of incompletely treated tuberculosis | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 20.0-80.0, Gastric Cancer Age 20~80 Informed consent No other malignancies Proximal gastric cancer met by following conditions Lesion located on proximal stomach (upper one third) Lesion below 5cm in size Lesion confined to proper muscle depth (cT2) No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1) If patients is only suitable to total gastrectomy, he will be excluded | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-65.0, Kawasaki Disease History of KD before the age of 18, with or without macroscopic coronary lesions in the childhood phase. (KD group only) years old or older at the time of the study Agree on participating to all explorations of the study Accept genotyping Absence of cardiovascular risk factors Atypical KD (KD group only) Documented or suspected coronary ischemia Refusal to participate to the study or sign the consent Contra-indication to the injection of iodinated contrast agents (allergy, renal failure) Hypersensitivity to dobutamine No effective contraception method for females with child bearing potential Breastfeeding, or pregnant females Treatment modifying endothelial reactivity History of severe intolerance to iodinated contrast agents Subjects who can't hold their breath for at least 20 seconds | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 3.0-999.0, Strep Throat Male and Female subjects three (3) years of age or older Patients exhibiting at least 3 of the following symptoms fever sore throat swollen lymph nodes in the neck redness of the throat and tonsils white or yellow patches on the tonsils Must be able to collect 2 throat swab samples from patient Patients currently undergoing antibiotic treatment will be excluded from study | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 3.0-999.0, Group A Streptococcus Strep Throat Presence of sore throat Redness of the posterior pharyngeal wall Tonsillar exudate Tonsillar swelling Tender anterior cervical adenopathy Fever, > 38º C (100.4ºF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS Rash, typical of scarlet fever Abnormal tympanic membranes Palatal petechiae Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 1.0-10.0, Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight) Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment Patients to whom the study drug can be administered by day 8 of disease Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B Patients confirmed to have HIV infection, or patients with a family history of HIV infection Patients who have a history of receiving treatment with infliximab or other biological products Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent | 2 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.083-18.0, Kawasaki Disease Coronary Aneurysm Treatment arm: Patients aged 1 month to 18 years with confirmed KD will be included in the study if they meet the following Patients with dilation of the right or left anterior descending coronary artery beyond a z-score of +3 during the acute febrile phase of KD Patients with aneurysms of the right or left main coronary arteries during the acute febrile phase of KD Patients with refractory KD after initial treatment with IVIG and dilated coronary arteries on an echocardiogram during the first month of KD Comparison arm: Patients aged 1 month to 18 years with confirmed KD, who do not meet to be included in the treatment group Patients with right or left anterior descending coronary artery measurements below a z-score of +3 during the acute febrile phase of KD The following patients will be excluded from this study Patients with clinically incomplete KD Patients whose parents refuse to administer doxycycline Patients with acute renal failure Patients with chronic liver and kidney disease | 1 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-16.0, Drug Hypersensitivity Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy) | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 19.0-999.0, Immune Thrombocytopenia Given written informed consent Male or female aged ≥ 19 Primary immune thrombocytopenia (ITP) Platelet <20x10^9 /L Patients who have taken adrenal cortical hormones and/or other immunosuppressive medications should maintain their stable doses before and during this study Patients who have participate in other interventional study within 30 days Inability in written/verbal communication Engaged with an elective surgery Pregnant or breast-feeding women Women of childbearing potential who do not agree with contraception during this study Patients who had experienced any hypersensitivity or shock with study drug or active ingredient Refractory to immunoglobulin therapy Secondary immune thrombocytopenia HIV-associated ITP Lupus-associated ITP | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-50.0, Healthy Volunteers Male or female of any race 50 years old, inclusive Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) Meets specific demographic requirements for the monitoring device under study Willing and able to provide written informed consent Able to participate for the duration of the evaluation A room-air baseline % modulation < 1.5% on all four fingers on the test hand Under 18 years or over 50 years of age Pregnant and/or lactating women Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute History of seizures (except childhood febrile seizures) or epilepsy History of unexplained syncope Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder Recent history of frequent migraine headaches: average of two or more per month over the last year Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-18.0, Kawasaki Disease The 5th revised edition of diagnostic for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy) bilateral conjunctival congestion changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa polymorphous exanthema changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation The cases were not in accordance with the recruited | 2 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.667-18.0, Kawasaki Disease Children Patients, male and female, at any age ≥ 8 months (10kg) of life, with KD according to the American Heart Association definition for complete or incomplete KD. fever ≥ 5 days and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter. In the presence of less than 4 clinical and 5 days of fever, the diagnosis of disease KD is proposed in case of coronary abnormalities (at least one dilated coronary artery with internal diameter ≥ 2,5 SD from the mean normalized for body surface area (Z score) as determined by echocardiography. For indicative purpose, in case of incomplete KD, other biological supportive for incomplete KD can help to ensure the diagnosis: leucocytosis, elevated CRP, elevated ESR, anaemia, hyponatremia, elevated ASAT, ALAT and gGT, hyperlipidaemia Patients who failed to respond to standard therapy of KD:, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg of IV Ig Weight ≥10Kg Patient, parent or legal guardian's written informed consent is required Patient with health insurance Patient agrees to have effective contraception for the duration of participation in the research Preterm and neonates, pregnancy Patients suspected with another diagnosis Patients with overt concomitant bacterial infection Patients previously treated with another biotherapy Patients with any type of immunodeficiency or cancer Patients with increased risk of TB infection Recent tuberculosis infection or with active TB Close contact with a patient with TB Patients recently arrived less than 3 months from a country with high prevalence of TB A chest radiograph suggestive of TB | 1 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.083-12.0, Kawasaki Disease Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002 the patients aged from 1 months to 12 years old All included patients required to sign an informed consent form the patients didn't receive treatment before The patients with the application of hormone or other immunosuppressive agents The patients didn't want to signed informed consent | 2 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 18.0-999.0, Cirrhosis Coagulopathy Patients 18 and older, admitted to the hospital Patients who have clinically documented cirrhosis Patients who are coagulopathic (INR > 1.5 and/or platelets < 50,000) Patients undergoing an endoscopic procedure or neurosurgical procedure Patients must not be pregnant Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis) Patients must not have an active infection (per PI discretion) Patients must not have any known hemostatic disorder | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 35.0-60.0, Cardiovascular Disease Men and women 35-60 years of age BMI ≥ 25 and ≤ 36 kg/m^2 LDL-C > 116 mg/dL Total Cholesterol below 240 mg/dL Triglycerides below 350 mg/d Non-smokers At least one of the following Systolic blood pressure 120-159 mmHg Diastolic blood pressure 80-99 mmHg History of acute or chronic inflammatory conditions or heart disease, kidney disease, liver disease, autoimmune disorders, or thyroid disease (unless controlled by medication and blood results within the previous 6 months are provided) History of diabetes mellitus (and/or a fasting glucose > 126 mg/dL at screening) Stage II hypertension (blood pressure ≥ 160/100 mmHg) Lactation, pregnancy, or desire to become pregnant during the study Unwillingness to discontinue nutritional supplements, herbs, or vitamins, unless approved by investigator Use of medications/supplements for elevated lipids, blood pressure, or glucose Chronic use of non-steroidal anti-inflammatory or immunosuppressant medication Conditions requiring the use of steroids Unwillingness to refrain from blood donation prior to and during the study Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator | 0 |
A 2-year-old boy is brought to the emergency department by his parents for 5 days of high fever and irritability. The physical exam reveals conjunctivitis, strawberry tongue, inflammation of the hands and feet, desquamation of the skin of the fingers and toes, and cervical lymphadenopathy with the smallest node at 1.5 cm. The abdominal exam demonstrates tenderness and enlarged liver. Laboratory tests report elevated alanine aminotransferase, white blood cell count of 17,580/mm, albumin 2.1 g/dL, C-reactive protein 4.5 mg, erythrocyte sedimentation rate 60 mm/h, mild normochromic, normocytic anemia, and leukocytes in urine of 20/mL with no bacteria identified. The echocardiogram shows moderate dilation of the coronary arteries with possible coronary artery aneurysm. | eligible ages (years): 0.0-18.0, Blistering Distal Dactylitis Children 0-18 years Distal blistering dactylitis collected or not collected Positive rapid Group A Streptococcus test Informed consent signed by the parents Subungual or pulp Whitlow Children not affiliated to the social security scheme Refusal by the parents to participate in the study | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-75.0, Lung Diseases Pulmonary Embolism Men and women suspected of having a pulmonary embolism and who met the to undergo angiography | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Breast Cancer Colorectal Cancer Lung Cancer Prostate Cancer Veno-occlusive Disease Histologically or cytologically proven breast, lung, colorectal, or prostate cancer that has failed prior chemotherapy or hormone therapy No active CNS metastases Hormone receptor status: Not specified Age: 18 and over Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3500/mm3 Platelet count at least 150,000/mm3 Fibrinogen above lower limits of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Prothrombin time no greater than 1.5 times ULN Active partial thromboplastin time no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No history of heparin associated thrombocytopenia At least 1 year since prior thromboembolic phenomenon such as deep venous thrombosis, pulmonary embolus, or clotted catheter No prior intolerance of unfractionated or low molecular weight heparin PRIOR No concurrent anticoagulation therapy No concurrent enrollment on systemic or radiation therapy study (therapy off study allowed) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Lung Diseases Pulmonary Embolism Venous Thromboembolism | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 35.0-999.0, Arthroplasty Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side) Patients who have given written informed consent to participate in this study Patients with a contraindication to contrast venography Patients with an increased risk of bleeding Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia Other or to be determined by the physician and study sponsor | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Small Cell Lung Cancer Written informed consent (patient's written understanding of and agreement to participate in this study) Patients with confirmed extensive small cell lung cancer (SCLC) No prior chemotherapy within 5 years of the diagnosis of SCLC Presence of either measurable or non-measurable SCLC by X-ray or physical examination At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient) At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting Laboratory Patients must have adequate bone marrow reserve and adequate kidney and liver function Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids Any active infection Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC Use of an investigational drug within 30 days before the first dose of study medication Women who are pregnant or lactating Patients of child-bearing potential who refuse to practice an adequate form of birth control Patients with clinical evidence of any stomach or intestinal (GI) condition Patients requiring treatment with the drug cyclosporin A | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-85.0, Pulmonary Hypertension Cancer Lung Disease Cardiothoracic Surgery Ages 18 to 85 years old Evidence of underlying lung disease by history and physical and/or chest x-ray and/or pulmonary function testing (PFT's) PHTN documented by Doppler Echocardiography ( Done with in last 30 days) Must be able to give an informed consent Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90) Active infection or sepsis as defined by fever and need for IV antibiotics Creatinine greater than 3.0 mg/dl Significant valvular disease as a cause for the PHTN Severe Thrombocytopenia (as defined by platelets less than 20,000 or INR > 1.6 Left Ventricle Ejection Fraction (LVEF) <40% (must be done with in the last 30 days prior to signing consent) Hypersensitivity to nesiritide or any of it's components | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-85.0, Heart Failure Cardiovascular Disease Acute Heart Failure Diastolic Heart Failure Congestive Heart Failure Heart Disease The patient population recruited for this study will patients being admitted for acute congestive heart failure. Eligible patients those who have near normal LV systolic function Age 18 to 85 years old Admitted with acute heart failure determined by: symptoms of fatigue; shortness of breath; edema; physical evidence of volume overload; and/or pulmonary edema by CXR LVEF > or = 40% on recent (< or = 1 month) echo or MUGA NYHA class III or IV on admission Baseline systolic blood pressure > 90 mm Hg Baseline BNP level > 100 pg/ml Able to sign informed consent and return for follow-up assessments Patients with clinically significant hypotension (defined as a systolic blood pressure (SBP) <90 mm Hg) Active infection/sepsis as defined by fever > 101.5 F, currently on IV antibiotics Creatinine greater than 3.0 mg/dl LV ejection fraction < 40% (must be done within the last 30 days prior to signing consent) Significant valvular disease or constrictive cardiomyopathy Severe Thrombocytopenia (as defined by platelets less than 20,000) or INR > 1.6 Hypersensitivity to nesiritide or any of its components Pulmonary capillary wedge pressure (PCWP) <16 mmHg If patient is of child-bearing age, a pregnancy test will be performed, and the patient is excluded if pregnancy test is positive | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Adult man or woman, aged ≥18 years, presenting with suspected lower-limb initial or recurrent DVT Moderate or high pre-test probability (PTP) for DVT Onset of symptoms occurred within the last 7 days Women of childbearing potential to have a negative pregnancy test as determined by measuring serum β-hCG levels at time of study enrolment Receiving anticoagulant therapy at therapeutic doses for >3 days Life expectancy <3 months Patient with a renal transplant Renal dysfunction: serum creatinine >1.5x upper limit of normal range Hepatic dysfunction: serum transaminases >3x upper limit of normal range Current pregnancy or lactation; or conception intended within 90 days of enrolment Of childbearing potential and unwilling to use adequate contraception for 30 days following enrolment Unable to undergo lower limb ascending venography on symptomatic leg(s) Allergy or other contraindication to intravenous contrast dye Prior exposure to murine or humanized antibodies | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Renal Insufficiency Adult patient aged > 18 years Admitted to an ICU with an expected ICU length of stay > 72 hours Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2 ICU admission for > 2 weeks at time of screening ICU admission within 3 months of cardiac surgery or neurosurgery Active bleeding or at high risk for bleeding complications Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours Receipt of > 2 doses of LMWH (prophylactic or therapeutic-dose) in the ICU Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening Receiving dialysis that requires anticoagulation (eg., slow continuous ultrafiltration [SCUF]) at time of screening | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 40.0-999.0, Heart Failure, Congestive We plan to all patients presenting to the ED with shortness of breath that are over 40 years old and present with an emergency department triage category of 3 or higher Patients presenting with a traumatic cause of dyspnea, patients with severe renal disease (serum creatinine level of more than 250 micro mmol/L, patients with cardiogenic shock, and patients who have an early transfer to another hospital (within 24 hrs) will be excluded | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Presenting signs and symptoms sufficiently suspicious for lower extremity DVT to warrant a formal radiology study in the opinion of the treating physician AND 2a. Moderate or high pre-test clinical probability of DVT (Wells Criteria) OR 2b. Low pre-test clinical probability of DVT with a positive D-dimer Documented lower extremity DVT within the past 60 days Anatomic abnormality that, in the judgment of the investigator, would preclude imaging of both femoral and popliteal veins on the affected leg (i.e. above-knee amputation or severe scarring from intravenous drug abuse in the inguinal area) Patient below the age of 18 years | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Critically Ill Deep Venous Thrombosis Admission to ICU Men and women greater than 18 years of age or older Expected to remain in ICU admission greater than 72 hours Contraindications to LMWH or blood products Trauma, post orthopedic surgery, post cardiac surgery or post neurosurgery patients Uncontrolled hypertension as defined by a systolic blood pressure > 180 mmHg or a diastolic blood pressure > 110 mmHg Hemorrhagic stroke, DVT, PE or major hemorrhage on admission or within 3 months Coagulopathy as defined by INR >2 times upper limit of normal [ULN], or PTT >2 times ULN Renal insufficiency as defined by a creatinine clearance <30ml/min A need for oral or intravenous or subcutaneous therapeutic anticoagulation Heparin allergy, proven or suspected heparin-induced thrombocytopenia (HIT) Receipt of >2 doses of UFH or LMWH in ICU Pregnant or lactating | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Heparin-Induced Thrombocytopenia trauma-surgical patient consent given minimum age 18 expected inpatient period at least 7 days need for thrombosis prophylaxis with heparin intolerance of one of the study drugs malignancy with life expectancy < 3 months pregnancy/lactation drug or alcohol abuse fibrinolytic therapy need for extracorporal circulation (e.g. cardiopulm. bypass, hemodialysis) at study entry participation in another clinical trial within 30 days prior to intended | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Thrombosis Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism Non-General Medicine Services patients | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Diabetes Diabetes Mellitus, Type 2 Diagnosis of type 2 diabetes HbA1C <= 12.0% within the past 12 months BMI <= 45.0 kg/m2 Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 70.0-999.0, Deep Vein Thrombosis Patients with a symptomatic and objectively confirmed Venous Thromboembolism (VTE) (lower limb deep venous thrombosis (DVT) or pulmonary embolus (PE)) with mandatory presences of objectively confirmed and treatment requiring DVT, i.e. symptomatic and objectively confirmed distal DVT or objectively confirmed, symptomatic or asymptomatic proximal DVT (confirmation of DVT should be performed by ultrasonography or venography within 48 hous prior to randomisation) Patients with an indication for DVT treatment with SC Low Molecular Weight Heparin (LMWH) or Unfractionated Heparin (UFH) followed by Oral Anticoagulant (OAC) for at least 90 days Hospitalized patients who, during SC anticoagulant treatment, will be followed, as specified in the protocol, on a daily basis either in the hospital or in an out-patient setting Patients at or above 75 years with a creatinine clearance less than or equal to 60 mL/min calculated according to the Cockcroft-Gault formula Patients at or above 70 years with a creatinine clearance less than or equal to 30 mL/min calculated according to the Cockcroft-Gault formula Patients receiving high dose (i.e. equivalent to a dose recommended for treatment of DVT) of UFH or LMWH or thrombolytic agents within the last 4 weeks except for UFH/LMWH during the last 36 hours prior to randomisation Patients on oral anticoagulant treatment (vitamin K-antagonists) at or within last 1 week prior to randomisation Patients with a symptomatic venous thromboembolism (VTE) requiring thrombolytic therapy or invasive intervention End stage renal disease patients requiring dialysis Surgery within 2 weeks prior to randomisation or planned surgery, epidural anaesthesia and/or spinal anaesthesia during the SC anticoagulant treatment period Planned use of acetylsalicylic acid in doses above 300 mg/day, NSAID or Dextran 40 at randomisation and during the SC anticoagulant treatment period Patients with a current overt bleeding or known haemorrhage condition (e.g. active G.I. ulcer) Patients with a platelet count < 100 x 10 9/L Patients with a known history of heparin-induced thrombocytopenia Patients with known severe hepatic insufficiency manifested as international normalized ratio (INR) greater than or equal to 1.5 | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 16.0-999.0, Adult Respiratory Distress Syndrome Pulmonary Hypertension After obtaining informed consent the following patients will be included All patients admitted to the ICU with pulmonary hypertension (mean PA > 35 mmHg) All patients in ICU with post operative pulmonary HTN (mean PA > 35 mm Hg) All patients with ARDS (PaO2/FiO2 < 200 arterial hypoxemia, bilateral infiltrates on Chest X-ray infiltrates on CXR and a wedge < 20 mm Hg on swan ganz parameters) or signs of heart failure Patients to be excluded will be those with Pulmonary embolus Cor pulmonale Ejection fraction of < 30%, wedge > 20 mm Hg Non-intubated patients Pediatric patients (< 16 yrs of age) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Breast Neoplasms Carcinoma, Ductal Adenocarcinoma Patient must be 18 and older Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast Patients must have undergone a segmental mastectomy (SM) or Mastectomy Patients must not have received prior radiation therapy to the breast at any time for any reason Any patient with active local-regional disease prior to registration is not eligible Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines Patients requiring oxygen Sarcoma or Squamous Cell pathology Right-sided breast cancers Metastatic disease to the breast | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Venous Thrombosis Patients who are scheduled for elective Cardiac or Thoracic Surgery Age > 18 years of age Patients with a clinical suspicion or a documented history of DVT/PE Patients who may require anticoagulation during the post-op period. (i.e. Patients with a history of A-fib, scheduled for a MAZE procedure or placement of a mechanical valve, or those on Coumadin/IV heparin preoperatively) Patients who have a history of HIT or if there is a suspicion of the patient having HIT pre-operatively Documented allergy to heparin, desirudin, or lepirudin Patients with a history of coagulation disorder Platelet count< 100 X109 /dl Active bleeding Serum Creatinine ≥ 1.5 mg/dl or CrCl ≤ 30 ml/min Patients with a baseline coagulopathy (INR > 1.5 or aPTT > 45 sec) Patients with liver disease | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 40.0-80.0, Chronic Obstructive Pulmonary Disease Established clinical history of moderate to severe COPD Post bronchodilator FEV1 of < 50% of predicted normal FEV1 / FVC ratio <70% Reversibility to 400mcg albuterol of less or equal to 10 predicted at Visit 1 Free from exacerbation in the 6 weeks prior to screening Current or former smoker with a smoking history of = 10 pack-years and has a history of COPD exacerbations Current asthma, eczema, atopic dermatitis and/or allergic rhinitis Has a known respiratory disorder other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) Has narrow-angle glaucoma, prostatic hyperplasia or obstruction of the neck of the bladder that in the opinion of the investigator should prevent the subject from entering the study Has undergone lung transplantation and/or lung volume reduction Female who is a nursing mother Requires regular (daily) long-term oxygen therapy (LTOT) Is receiving beta-blockers (except eye drops) Has a serious, uncontrolled disease likely to interfere with the study Has received any other investigational drugs within the 4 weeks prior to Visit 1 Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Deep Vein Thrombosis Pulmonary Embolism Deep Vein Thrombosis With Pulmonary Embolism Patients aged 18 years or more with suspected or proven DVT/PE whom the clinician intended to anticoagulate DVT/PE severe enough to require thrombolysis or pulmonary embolectomy DVT/PE in the preceding 3 years Neoplasia diagnosed/treated within previous 3 years Pregnancy Known major thrombophilias Prolonged or continuous immobility or confinement to bed Previous allergy to heparin or warfarin Requirement for long-term anticoagulation Inability to give informed consent | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Embolism Phase I Experienced or is scheduled for at least one of the following Hip or knee replacement surgery Hip or acetabular fracture surgery Pelvic fracture Decompression for spinal stenosis surgery Scoliosis corrective surgery Craniotomy surgery for brain tumor Surgery for any of the following cancers: bladder, colon (including caecum and rectum), kidney, ovary, pancreas, or uterus Phase I Currently undergoing treatment for PE or has received treatment for PE in the 4 weeks prior to study entry Hospitalized for fewer than 2 days Anatomic abnormality that would prevent use of a mouthpiece Living situation that makes follow-up difficult (e.g., homeless, incarcerated) Phase II Clinical suspicion of PE with signs or symptom suggestive of PE within 24 hours of presentation and at least one risk factor for PE, as defined under the as outlined in this protocol CTA of pulmonary arteries ordered by clinical care providers years or older or an emancipated 17 year old Written informed consent Phase II | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.0-999.0, Venous Thromboembolism Pulmonary Embolism Cancer Deep Vein Thrombosis COPD Ultrasound-confirmed DVT patients from 183 institutions | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-45.0, Healthy Males 18 to 45 years of age Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke History of important bleeding episodes Previous allergic reaction to immunoglobulin Present or previous history of severe allergy, for example asthma or anaphylactic reactions FVIII:C <50% at screening Clinically significant out of range values for any coagulation test during screening Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402 | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 40.0-999.0, Venous Thromboembolism Patient with an acute medical condition requiring bed rest for at least 3 days, and hospitalized for at least one of the following medical conditions Congestive heart failure (New York Heart Association [NYHA] class III/IV) Acute respiratory failure (not requiring mechanical ventilation) Acute infection (without septic shock)* Acute rheumatic disorder* Acute episode of inflammatory bowel disease* Patient with one of these conditions should have at least one additional risk factor for venous thromboembolism (VTE) among the following Age ≥ 75 years Active cancer or myeloproliferative disorders (having received treatment for cancer within the last 6 months) Previous VTE Previous surgery with general anesthesia within 30 days before in the study Patient requiring a curative anticoagulant or thrombolytic treatment Patient at risk of bleeding Stroke Known hypersensitivity to heparin or enoxaparin sodium End stage renal disease or patient on dialysis | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 21.0-999.0, Respiratory Diseases Pulmonary Diseases Thoracic Diseases Lung Diseases All adult ( ≥ 21 years old ) patients (inpatients and outpatients) under the care of the Department of Respiratory and Critical Care Medicine between 1/07/2008 and 31/05/2009 will be considered eligible Children may have too small body sizes for the current standard sensors and will not be recruited Other will be ability to provide informed consent Conditions that will prevent the placement of sensors oh the patients back such as bony/chest wall deformity and contagious skin conditions The presence of a pacemakers and pregnancy are also considered contraindications because of the yet undefined safety issues associated with these conditions | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Coagulation, Blood Compression Devices, Intermittent Pneumatic Postoperative Complications Thrombelastography Elective major abdominal surgery for neoplasm Planned admission to postsurgical ICU due to the patient's meeting one or more of the following ASA Physical Status Class 4 Surgery of modified Johns-Hopkins class ≥IV ASA 3 with modified Johns-Hopkins class 3 surgery Expected duration of surgery ≥8 h History of coagulation abnormalities, either congenital or acquired Ongoing treatment with anticoagulants/antiplatelet agents other than LMWH or hormones Massive edema of the legs Severe peripheral arteriopathy or neuropathy Malformations or recent surgery/trauma to the lower extremities | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.0-999.0, Thrombosis Male or female subjects who have a diagnosis of chronic DVT that is at least 2 weeks old and are free from an acute DVT on top of your chronic DVT Male and female patients who have been diagnosed with an acute blood clot by the Diagnostic Vascular Lab and w/symptoms occurring within the previous 2 weeks Patients under the age of 18 who give assent (permission) and whose parents give consent Adult patients who give consent | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-80.0, Partial Nephrectomy Patients who have a solitary kidney and present for a partial nephrectomy Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney History of current renal disease beyond the diagnosis of renal malignancy Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Chronic Kidney Disease chronic kidney disease stade V treated with hemodiafiltration age >18 year Hematocrit > 30% treatment with vitamin K antagonists treatment with other anti-coagulants or heparin besides the heparin used during dialysis active bleeding, infection or malignancy heparin associated allergy hepatic failure trombocytopenia < 120.000/µl | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Non-Small Cell Lung Cancer Locally advanced or metastatic NSCLC (stage IIIB or IV) Patients who are not candidates for radical combined modality treatments or high-dose radiation therapy At least one measurable lesion according to Good performance status Adequate haematological, renal and liver function Written informed consent Previous chemotherapy for NSCLC Brain metastasis History of cerebral haemorrhage, neurosurgery within 3 previous months or surgery within the past 6 months Indication for anticoagulant therapy, thrombolytic therapy or antiplatelet therapy for cardiovascular disease Concomitant therapy with an anti-angiogenesis agent Contra-indication for LMWH Life expectancy of < 3 months Serious concomitant systemic disease, uncontrolled arterial hypertension, active peptic ulcer or other condition which does not permit study treatment or follow-up required to comply with the study protocol | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-90.0, Deep Vein Thrombosis Coronary Artery Bypass Surgery Venous Thromboembolism Subject In order to be enrolled in the study, subjects must meet all of the as listed below Consecutive patients undergoing isolated or redo isolated CABG Patients must provide written informed consent Patients must agree to comply with study procedures for the entire length of the study Must be 18 years old or greater Subject Any subject that meets any of the listed below at baseline will be excluded from study participation Patients with medical history that requires chronic anticoagulation with unfractionated heparin or coumadin or LMWH or heparinoids (i.e. previous DVT, pulmonary embolism, atrial fibrillation, heart valve replacement) Patients with contraindications to anticoagulation (coagulopathy e.g, INR>/=1.5, generalized bleeding disorders, peptic ulcer disease, hemorrhagic or ischemic stroke, etc within last 3 months) Patients who are unable to undergo a doppler ultrasound of the lower extremities Renal insufficiency (creatinine clearance < 30 mL/min) Patients who have a body weight < 50 kg Patients receiving continuous (indwelling) epidural Physician diagnosed acute or chronic hepatic failure Pregnancy | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Isolated Distal DVT Proximal DVT Pulmonary Embolism suspected deep vein thrombosis of a leg intermediate/high pre-test clinical probability or high D-dimer levels age < 18 years presence of proximal DVT suspected isolated iliac DVT symptoms/signs lasting from > 30 days presence of symptoms of pulmonary embolism pregnancy or puerperium full dose treatment with heparin or derivatives from > 1 day presence of superficial vein thrombosis limited life expectancy (< 6 months) geographically inaccessible location | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-40.0, Diaphragm Mobility Breathing Exercises Incentive Spirometry Diaphragmatic Breathing Being 18 to 40 years old Having a normal body mass index Being a non-smoker Not knowing the DB and the IS techniques Reporting the absence of respiratory diseases Presenting alteration in respiratory function detected by functional analysis of lung volume and capacity Inability to understand or perform the procedure | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 0.0-18.0, Thrombosis Functioning central venous catheter in the upper or lower venous system Cohort A: Asymptomatic patients having placement of a new central venous catheter in the last 40±20 days Cohort B: Subjects who have experienced symptoms for a CVC-related DVT with a CVC in place or subjects who have been incidentally identified by radiographic imaging (imaging modalities to diagnose an incidental CVC-related DVT may but is not exclusive of Echocardiogram, CT scan, MRI, or Ultrasound) performed for other clinical reasons, as having a CVC-related DVT in the veins where the current catheter is placed Males and females from full-term newborns to < 18 years For Cohort A subjects only, present therapeutic dosing of a systematic anticoagulant, systemic thromboprophylaxis or antiplatelet therapy. Local thromboprophylaxis [flushes, low dose infusions of heparin of up to 5 u/kg/hr or locks with heparin, urokinase, t-plasminogen activator] according to standard-of-care at the respective center will be allowed Patients unable to undergo contrast enhanced magnetic resonance imaging Renal function < 50% of normal for age and size | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Venous Thromboembolism Neoplasms Patients with cancer and confirmed pulmonary embolism (PE) or deep vein thrombosis (DVT) of the leg who have been treated for minimally 6 and maximally 12 months with therapeutic doses of anticoagulants, i.e. LMWH or VKA or a new anticoagulant in a trial Written informed consent Indication for long-term anticoagulant therapy (e.g. because of metastasized disease, chemotherapy) Legal age limitations (country specific), minimum age at least 18 years Indications for anticoagulant therapy other than DVT or PE Any contraindication listed in the local labeling of LMWH or VKA Childbearing potential without proper contraceptive measures, pregnancy or breastfeeding Life expectancy <3 months | 1 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Pulmonary Embolism Pulmonary embolism suspicion | 2 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Psoriatic Arthritis Males or females, aged ≥ 18 years at time of consent Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration Meet the Classification for Psoriatic Arthritis (CASPAR) PsA at time of screening Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs) May not have axial involvement alone Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine Have ≥ 3 swollen AND ≥ 3 tender joints Males & Females must use contraception Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed Pregnant or breast feeding History of allergy to any component of the investigational product Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF) blocker | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-49.0, Severe Oligohydramnios Patients above 18 years, who are able to consent Singleton pregnancy Normal structural examination between 16 and 20 weeks of gestation Gestation between 18 and 34 weeks (the pregnancy duration determined by ultrasound verification within the 20th week) At least two US examinations at the presentation for confirmation and for the diagnosis of persistent oligohydramnios Follow up ultrasound examinations weekly in both groups pPROM; 2. Fetal structural anomaly detected at prenatal ultrasonography, or fetal chromosomal abnormalities involving autosomes; 3. Symptoms referring incomplete abortion before 24 weeks of gestation; 4. Maternal contraindications to intervention or prolongation of pregnancy, including severe medical conditions in pregnancy that make the intervention riskful; 5. No active premature labor (shortened cervix <15 mm, <3 cm of cervical dilatation; >6/hour uterine contractions) after 24 weeks of gestation; 6. Cervical cerclage in place; 7. Clear signs of maternal or fetal infection (2 or more of the following: maternal tachycardia >100/min, maternal temperature >38°C, maternal white blood count cells (WBC) >15,000/ml, maternal C-reactive protein (CRP) >20 mg/l, uterine tenderness, foul-smelling vaginal discharge, fetal tachycardia >160 bpm); 8. Suspicion of placental abruption (uterine tenderness and bleeding episodes); 9. Previous invasive procedure in the pregnancy; 10. Fetal condition mandating immediate delivery; 11. Severe bleeding at present; 12. Maternal HIV and HBV/HCV infection; 13. Multiple gestation | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Ablation of Atrial Fibrillation Patients will be included if they present for ablation with paroxysmal or persistent atrial fibrillation as defined by the Heart Rhythm Society and their left atrium is < 6.1 cm (volume) Patients must be symptomatic with their AF as noted by their inability to perform their daily activities due to shortness of breath, fatigue, palpitations or other debilitating symptoms Paroxysmal atrial fibrillation is defined as atrial fibrillation that resolves on its own within 7 days of onset Persistent atrial fibrillation is defined as atrial fibrillation that does not resolve on its own and requires medical intervention to medication therapy and/or electric cardioversion Patients will be excluded if they present with long standing persistent atrial fibrillation as defined by the Heart Rhythm Society All patients with MV +2 mitral regurgitation will be excluded Require other cardiac surgery procedures will be excluded Are unable to take anticoagulation Are unable to take any prescribed anti arrhythmic medication Have a left atrium measuring greater than 6.0 cm (volume) Have had previous catheter ablation for atrial fibrillation Have had previous pace maker implantation Are less than 18 years of age Do not speak English and no translation can be provided | 0 |
A 56-year-old female on 20th day post-left mastectomy presents to the emergency department complaining of shortness of breath and malaise. The patient says that she has remained in bed for the last two weeks. The physical examination reveals tenderness on the left upper thoracic wall and right calf. The surgical incision shows no bleeding or signs of infection. Pulmonary auscultation is significant for bilateral decreased breath sounds, especially at the right base. Laboratory tests reveal an elevated D-dimer. | eligible ages (years): 18.0-999.0, Perioperative DVTs Age 18+ and consentable Anticoagulation therapy or known DVT | 0 |
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