eligible ages (years): 4.0-13.0,  All  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)


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,  All  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


eligible ages (years): 20.0-80.0,  All  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


eligible ages (years): 18.0-65.0,  All  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


eligible ages (years): 3.0-999.0,  All  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


eligible ages (years): 3.0-999.0,  All  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


eligible ages (years): 1.0-10.0,  All  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


eligible ages (years): 0.083-18.0,  All  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


eligible ages (years): 0.0-16.0,  All  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)


eligible ages (years): 19.0-999.0,  All  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


eligible ages (years): 18.0-50.0,  All  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.)


eligible ages (years): 0.0-18.0,  All  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


eligible ages (years): 0.667-18.0,  All  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


eligible ages (years): 0.083-12.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 35.0-60.0,  All  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


eligible ages (years): 0.0-18.0,  All  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


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,  All  Lung Diseases Pulmonary Embolism Men and women suspected of having a pulmonary embolism and who met the to undergo angiography


eligible ages (years): 18.0-999.0,  All  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)


eligible ages (years): 0.0-999.0,  All  Cardiovascular Diseases Lung Diseases Pulmonary Embolism Venous Thromboembolism


eligible ages (years): 35.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-85.0,  All  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


eligible ages (years): 18.0-85.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 40.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  Thrombosis Patients admitted to General Medicine Services with a primary or secondary diagnosis related to venous thromboembolism  Non-General Medicine Services patients


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 70.0-999.0,  All  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


eligible ages (years): 16.0-999.0,  All  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)


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 40.0-80.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 0.167-4.917,  All  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)


eligible ages (years): 0.0-999.0,  All  Venous Thromboembolism Pulmonary Embolism Cancer Deep Vein Thrombosis COPD Ultrasound-confirmed DVT patients from 183 institutions


eligible ages (years): 18.0-45.0,  All  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


eligible ages (years): 40.0-999.0,  All  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


eligible ages (years): 21.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 0.0-999.0,  All  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


eligible ages (years): 18.0-80.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-90.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-40.0,  All  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


eligible ages (years): 0.0-18.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  Pulmonary Embolism Pulmonary embolism suspicion


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-49.0,  All  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


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-999.0,  All  Perioperative DVTs Age 18+ and consentable  Anticoagulation therapy or known DVT


eligible ages (years): 18.0-999.0,  All  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


eligible ages (years): 18.0-75.0,  All  Rupture Venous Thromboembolism Venous Thrombosis Surgical Wound Infection Achilles tendon rupture operated on within 96 hours of diagnose  Inability or refusal to give informed consent for participation in the study Ongoing treatment with anticoagulant therapy Inability to comply with the study instructions Known kidney disorder Heart failure with pitting oedema Thrombophlebitis Recent thromboembolic event (during the preceding 3 months) Recent surgery (during the preceding month) Presence of known malignancy Current bleeding disorder


eligible ages (years): 18.0-999.0,  All  Pulmonary Embolism Chronic Obstructive Pulmonary Disease known or suspected COPD COPD-exacerbation  other causes of dyspnea unable to perform CT pulmonary angio (contrast allergy, pregnancy) already included in the study (each patient included only once) use of anticoagulants


eligible ages (years): 18.0-999.0,  All  Prophylaxis of Venous Thromboembolic Events Male or female subjects aged ≥ 18 years Written informed consent Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures  Pregnancy at the time of screening Indication for anticoagulation other than post-operative thromboprophylaxis Active bleeding or high risk of bleeding Anticipated continued use of neuraxial catheter after surgery Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT Uncontrolled hypertension Impaired liver function (transaminase >3 X ULN) or history of hepatic insufficiency Creatinine clearance <30 mL/min Antiplatelet agents other than low dose aspirin (< 200mg) The use of intermittent pneumatic compression


eligible ages (years): 18.0-40.0,  All  Pregnancy pregnant women undergoing planned caesarean section h-40th week of pregnancy age 18-40 years  disapproval or non-cooperation of the mother allergy to LMWH coagulation disorders or the risk of anticoagulant therapy in the last 3 months signs of infection history of cancer signs of thrombosis or a history of thrombosis the ongoing non-physiological pregnancy significant obesity, or other severe comorbidity


eligible ages (years): 18.0-999.0,  All  Thrombosis, Venous age 18 and older at least one record of a primary inpatient discharge diagnosis of cancer (index hospitalization) a procedure code for a cancer-related surgery during the index hospitalization a code for an anticoagulant treatment (dalteparin, enoxaparin, fondaparinux or unfractionated heparin (UFH)) as thromboprophylaxis therapy during the day prior to or two days after cancer-related surgery during the index hospitalization (this is the INDEX EVENT)  a record that the patient received more than one injectable anticoagulant on Day 1 of anticoagulant therapy a record that the patient received anticoagulant therapy prior to index anticoagulant a primary diagnosis code of DVT, PE, or major bleed evidence of an outpatient emergency department or hospital outpatient clinic visit that included a diagnosis code for DVT or PE during the 6 months prior to the index hospitalization patient records for patients transferred from another facility outside Premier system on index hospitalization


eligible ages (years): 19.0-999.0,  All  Air Embolism as A Complication of Medical Care Subject is undergoing ERCP as part of their medical care Subject will be of age 19 or older  Subject positioning for the ERCP is prone, thereby inhibiting the performance of the TTE Subject intolerance of the pressure of the TTE probe Subject body habitus interferes with obtaining adequate images to assess for intra-cardiac air


eligible ages (years): 18.0-999.0,  All  Deep Venous Thrombosis Pulmonary Embolism Meniscectomy Diagnostic Arthroscopy Removal of corpora libera  Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study


eligible ages (years): 18.0-999.0,  All  Deep Venous Thrombosis Pulmonary Embolism All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications Trauma of the lower leg Surgery of the lower leg followed by lower leg immobilization with a plaster cast Non-traumatic indications  Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy) Pregnancy Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence) Mental of physical disability to fulfill study requirements Insufficient knowledge of the Dutch language Previous participation in the Pot-(K)Cast study


eligible ages (years): 18.0-999.0,  All  Thromboembolic Events Post-operative Bleeding primary Uni/bilateral THR/TKR, revision THR/TKR or uni-KR in fast-track setup, Discharged in 3 +-2 days  not a danish citizen


eligible ages (years): 30.0-90.0,  All  Deep Vein Thrombosis patients that underwent cemented total knee arthroplasty  post-operative infection inadequate follow-up


eligible ages (years): 18.0-999.0,  All  Acute Pulmonary Embolism consecutive patients with acute pulmonary embolism  age <18 years


eligible ages (years): 18.0-89.0,  All  Dyspnea Subjects are included if they are between the ages of 18-89 and present to the Emergency Department with a chief complaint of shortness of breath or dyspnea  known history of asthma are 20 or more weeks pregnant, or have had thoraco-abdominal trauma in the past 72 hours


eligible ages (years): 18.0-999.0,  All  Pregnancy Deep Vein Thrombosis Pregnant women with clinically suspected DVT  Age less than 18 No available informed consent Associated suspicion of pulmonary embolism Ongoing anticoagulant treatment Planned anticoagulant treatment at therapeutic dosage during pregnancy


eligible ages (years): 16.0-999.0,  All  Chest Pain All patients over the age of 18 years presenting with the leading symptom of first time or recurrent acute chest pain in the emergency room of the Department of Internal Medicine, University Hospital of Zurich  Missing informed consent Cardiopulmonary unstable patients No self reported chest pain Recent thoracic surgery within1 year, inflammatory joint disease, fibromyalgia, cardiogenic shock


eligible ages (years): 18.0-999.0,  All  Venous Thromboembolic Disease Deep Vein Thrombosis Pulmonary Embolism Admitted to Scripps Mercy Trauma Service ≥18 Years old Stratified to either Significant or Highest risk of VTE by ACCP guidelines  Estimated Injury Severity Score (ISS) ≤9 Likely to be discharged before hospital day 7 Systemic coagulopathy (International Normalized Ratio [INR] of ≥1.2) Body Mass Index (BMI) >40 Likely to Survive for <7 Days Pregnancy Evidence of renal insufficiency (Cr ≥1.3) Delayed transfer to this facility (>24 hrs) Prisoners


eligible ages (years): 24.0-65.0,  All  Pulmonary Embolism Diagnostic Uncertainty Clinical Reasoning Evidence Based Medicine Visualization of Uncertainty Medical students, University of Calgary, in clerkship who finished at least 4 weeks of a block of medicine rotation at any hospital site First year subspecialty or Internal Medicine residents Practicing physicians in the subspecialties of Internal Medicine or Emergency Medicine  Physicians in the subspecialty of Haematology or Respiratory


eligible ages (years): 18.0-80.0,  All  Pain Female 80 years of age TMJ arthralgia Masticatory myalgia TMJ sounds History of at least 6 weeks use of occlusal appliance therapy  Contraindication to sedation including pregnancy or medical history History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy History of steroidal injection into TMJ History of trauma to TMJ TMJ pain longer than 3 years History of narcotic drug use on a scheduled basis Current active infection


eligible ages (years): 18.0-45.0,  All  Venous Insufficiency Pregnant women 18-45 years of age Fetal gestation between 8-20 weeks Patient is seeking care for the pregnancy at one of the study locations (Johns Hopkins East Baltimore Campus, Johns Hopkins Bayview Medical Center, and Johns Hopkins at White Marsh) Ability to complete informed consent and willingness to comply with protocol (return for all follow-up visits & participate in phone interviews)  Inability to wear compression stockings Women who currently have been prescribed to wear compression stockings by a medical professional Chronic dermatological condition (i.e. psoriasis) Chronic deep vein thrombus or chronic phlebitis In women with varicose veins: Presence of primary outcome (superficial thrombophlebitis or DVT) on first visit ultrasound


eligible ages (years): 18.0-80.0,  All  Snoring every night snoring no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids) no smoking for the last 6 months no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and written informed consent from each patient  duration of snoring less than 60 minutes during sleep study, and central apnoeas more than five percent of total apnoeas


eligible ages (years): 18.0-999.0,  All  Pulmonary Arteriovenous Malformations Patients are eligible for in the study if all the following are met Documented presence of new (untreated) pulmonary AVMs requiring embolization Definite clinical diagnosis of HHT or genetic diagnosis of HHT Age ≥18 years Able to provide informed consent  Patients will be excluded from the study if, in the opinion or knowledge of the Principal Investigator any of the following criterion is present Participants with multiple AVMs within close proximity where identification of the aneurysm seen on CT cannot be precisely isolated for randomization purposes Contra-indications to embolotherapy Severe chronic renal failure, without availability of dialysis Severe pulmonary hypertension (PA systolic estimated at >60mmHg)


eligible ages (years): 18.0-80.0,  All  Treatment of Submassive Pulmonary Embolism Patients with acute (< or = 14 days)symptomatic pulmonary embolism by CT Angiogram of the thorax with embolus involving at least one main or lower lobe pulmonary artery and RV:LV ratio > 0.9  age > 80 Recent thrombolytic therapy (with in 4 days) Active bleeding or know bleeding diathesis Known coagulopathy (including treatment with vitamin K antagonists) INR > 3 and/or PTT > 50 Thrombocytopenia (PLT cound < 100,000) History of any intracranial or intraspinal surgery, trauma or bleed Intracranial neoplasms, AVM, or aneurysm Recent (< 1 month) GI bleed Recent (< 3 months) internal eye surgery or hemorrhagic retinopathy Recent (< 7 days) major surgery, trauma, or obstetrical delivery


eligible ages (years): 18.0-999.0,  All  Multiple Pulmonary Emboli Patients referred for CT pulmonary angiogram to pulmonary embolus  Class 3 or 4 Congestive Heart Failure Supraventricular tachycardia History of contrast allergy Unable to give informed consent Patients with serum creatinine >1.28 mg/dl without referring physician approval


eligible ages (years): 18.0-999.0,  All  Pulmonary Edema Age over 18 years Belongs to one of the following categories A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following Dyspnea at rest or with minimal activity Rales on auscultation Evidence of pulmonary congestion or edema on chest X-ray BNP level >400 pg/ml B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 must be met No dyspnea at rest No rales on auscultation  Decompensated left HF subgroup & Non CHF controls Pneumonia currently or in the past 1 month prior to Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS) Interstitial lung disease Severe kyphosis, scoliosis or chest wall deformity Pregnant women Compensated left HF subgroup Chronic obstructive pulmonary disease (COPD) Asthma


eligible ages (years): 19.0-85.0,  All  This Study Will Provide Data Comparing Safety of LMWH Versus UFH in the Treatment of Acute PE Cases Who Require Thrombolytic Treatment. Adults, age ≥ 18 years Patients who have signed the study informed consent form prior to initiation of any study-related procedure Acute massive PE patients who require thrombolytic treatment  Patients who have a contraindication to use of anticoagulation and thrombolysis, such as active bleeding, stroke, cranial trauma, or neurologic surgery within the preceding 6 months, current pregnancy, major surgery, or biopsy within the preceding 7 days, major trauma within the preceding 10 days, gastrointestinal bleeding within the preceding 1 months during their admission Patients who received any anticoagulation medication prior to admission to the hospital


eligible ages (years): 50.0-999.0,  All  Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s)  An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)


eligible ages (years): 18.0-999.0,  All  Obesity Adult patient undergoing laparoscopic sleeve gastrectomy The patient undergoes the surgery in the surgical wing of the Tel-Aviv Sourasky Medical Center The patient has received full information regarding the studies nature, has agreed to participate and has given informed consent (documented by a signed informed consent form)  Patients with a previous Venous Thromboembolic Event Patients requiring an IVC filter Patients with known thrombophilia due to coagulation factor disorders (i.e factor V leiden) Patients with a bleeding disorder Patients with renal failure


eligible ages (years): 18.0-70.0,  All  Obesity Competent patients enrolled in the pre or post-operative bariatric surgery program at the Center for Nutrition and Weight Management at GMC, Danville, PA Ability to perform a 6 Minute Walk Test Aged 18 through 70 Willingness to receive dietary recall phone calls and accessibility to a telephone  Patients with severe lung disease requiring oxygen therapy Pulmonary embolus or pulmonary infarction Patients with cardiopulmonary disease (e.g., prior myocardial infarction, coronary artery bypass, or vascular stent) Unstable angina Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise Patients with any health reason that limits walking Patients with a temporary injury that limits walking Patients who use a wheelchair, other assistive device for walking, or have difficulty ambulating during activities of daily living Patients predetermined to be illiterate or incompetent Patients who are currently pregnant or have been pregnant at any time since bariatric surgery


eligible ages (years): 18.0-999.0,  All  Deep Vein Thrombosis TKA candidacy, osteoarthritis, patients able to understand study intent, and agree to study participation  Subjects with personal or family history of DVT, currently taking antiplatelet/anticoagulant drugs, genetic risk factor positive for VTE, pronounced thrombocytopenia, GI bleed within 6 months of surgery, NSAID intolerance, orthopaedic and medical co-morbidities that would prevent postoperative rapid mobilization and compliance with MCD such as extra-articular pathology with referred pain to the knee (spinal stenosis, neuropathy, ipsilateral hip disease), severe knee deformity, post-traumatic and inflammatory arthritis, BMI above 40, active knee sepsis, remote sites of active infection, ASA class > lll, cardiac disease failing medical clearance, severe liver disease, peripheral artery disease, seizure disorder, alcohol abuse, smoking abuse


eligible ages (years): 0.25-16.0,  All  Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent  Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening


eligible ages (years): 18.0-999.0,  All  Pulmonary Embolism Concern for PE by attending physician and CTPA ordered  If patient is under the age of 18, a prisoner, or a ward of the state CTPA ordered but not performed


eligible ages (years): 18.0-999.0,  All  Deep Vein Thrombosis DVT Age 18 or older Suspect of having DVT  Known DVT DVT with in previous 6 months DVT Ultrasound within the last 6 months


eligible ages (years): 18.0-999.0,  All  Osteoarthritis with osteoarthritis scheduled for elective primary unilateral THR or TKR provided informed consent can read, write and speak English  history of arterial or venous thromboembolic disease (myocardial infarction, symptomatic ischemic heart disease, atrial fibrillation, cerebrovascular accident, deep-vein thrombosis, pulmonary embolus, or thrombogenic cardiac valvular disease or rhythm disease) pre-operative Hg of <120 g/L Known allergy to Tranexamic Acid Coagulation disorder Acquired disturbances of color vision Hepatic insufficiency, any history of liver disease Renal insufficiency (on dialysis) Preoperative prophylactic use of antiplatelet or anticoagulant therapy such as Clopidogrel, Warfarin, dabigatran or Rivaroxaban. This does not low dose Aspirin (81mg) Patients with a history of subarachnoid hemorrhage [20] Simultaneous bilateral THA or TKA


eligible ages (years): 18.0-65.0,  All  Bariatric Surgery Obesity Men or women, 18 to 65 years old with a BMI of 35 kg/m2 or greater who will be undergoing bariatric surgery (VSG and RYGB) Signed written informed consent Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug Women must not be breastfeeding  History of documented clotting/coagulation disorder History of cancer (within the last year) Any diagnosis requiring anti-coagulation History of hypersensitivity reaction to apixaban Active clinically significant bleeding Creatinine > 1.5 mg/dL Participants currently receiving any type of anticoagulation or blood thinning medications, including heparin, low molecular weight heparins, Plavix, aspirin Participant who is taking any of the excluded medications Combined P-glycoprotein and strong CYP 3A4 inhibitor Combined P-glycoprotein and moderate CYP 3A4 inhibitor


eligible ages (years): 21.0-59.0,  All  Respiratory Failure Healthy male or female volunteers in the age group  Any acute or chronic cardiopulmonary disorder including a simple common cold


eligible ages (years): 16.0-999.0,  All  Pregnancy Suspected Deep Vein Thrombosis Compression Ultrasound D-dimer Unselected pregnant women (preciously documented positive beta hCG on urine or serum pregnancy tests) with Suspected acute symptomatic deep vein thrombosis Defined as new leg swelling or edema with onset in the last month or new leg pain (buttock, groin, thigh or calf) with onset in the last month  Prior major VTE (proximal DVT or segmental or greater PE) Below the age of legal consent in jurisdiction of residence (18 years old for Quebec and 16 years old for rest of Canada) Unable or unwilling to provide informed consent Concomitant symptoms of suspected pulmonary embolism (chest pain or shortness of breath or syncope/pre-syncope or unexplained tachycardia) Need or plan for ongoing anticoagulant therapy (>2 weeks), at any dosage (i.e. prophylaxis or treatment dosage), throughout the ante-partum period Need for therapeutic anticoagulant therapy in the post-partum period (i.e. patients that are/will be treated for superficial phlebitis, mechanical valves, atrial fibrillation or other indications)


eligible ages (years): 0.0-999.0,  All  Bronchial Secretion Retention Intubated patients (with and without mechanical ventilator support) with secretion 1.5 ml/h, If the patients are breathing with mechanical ventilation, the PEEP level must be less than 6 centimeter of water and one of following Clinical and radiologic diagnosis of pulmonary infection Acute or chronic airway inflammation disease such as pneumonia, bronchiectasis, chronic obstructive pulmonary disease or chronic bronchitis and at least one sign of secretion accumulation in bronchial such as medium-coarse crackle, wheezing, persistent rhonchi and decrease breath sound Stable of cardiopulmonary function at least 2 days before the study and the patients don't receive the vasopressors drug within 5 days before collects the data Stable of hydration status or positive fluid balance at least 2 days before collects the data Ability to breathe or tolerate spontaneously breathing trial with T-piece at least 30 minutes with fraction of inspired oxygen less than 0.4 and without developing hypoxemia Good conscious and well cooperation  Pneumothorax (nontreated) Massive hemoptysis Acute myocardial infarction (with angina chest pain) High intracranial pressure (>20 mm Hg) Major arrhythmia


eligible ages (years): 18.0-999.0,  All  Arthropathy of Hip Arthropathy of Knee Patients undergoing primary unilateral total knee arthroplasty or primary unilateral total hip arthroplasty under spinal anesthesia at Columbia University Medical Center/ New York Presbyterian Hospital  Non-English speaking Patient refusal to participate Weight exceeding 100kg Baseline hemoglobin of less than 10 Repeat, revision, or bilateral surgery Known sensitivity or allergy to Tranexamic Acid Active intra-vascular clotting History of coagulopathy or congenital thrombophilia Thromboembolic event in the 12 months prior to enrollment Percutaneous coronary intervention requiring a drug eluting stent in the 12 months prior to enrollment


64-year-old obese female with diagnosis of diabetes mellitus and persistently elevated HbA1c. She is reluctant to see a nutritionist and is not compliant with her diabetes medication or exercise. She complains of a painful skin lesion on the left lower leg. She has tried using topical lotions and creams but the lesion has increased in size and is now oozing.

eligible ages (years): 10.0-18.0,  All  Diabetes Mellitus, Non-Insulin-Dependent Approximately 30 pediatric patients (ages 10-18) believed to have a diagnosis of type 2Y. Each subject must have been diagnosed for at least one year  Patients over the age of 18 or under the age of 10 Patients in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol


eligible ages (years): 0.0-999.0,  All  Diabetes Mellitus Foot Ulcer Peripheral Neuropathy History of Diabetes Mellitus Limitation of dorsiflexion ankle range of motion to zero degrees or less Recurrent or nonhealing ulcer (Grade II, Wagner scale)  Nonambulatory patients or those that would not benefit from the Achilles lengthening procedure Patients with a history of CVA or other significant neurological problems complicating their rehabilitation Patients with a history of midfoot or hindfoot Charcot fractures Patients with an Ankle-Arm index < 0.45 or absolute toe pressure < 40 mm Hg Patients medically unfit for the anesthesia required for this Achilles lengthening procedure


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcers Diabetic patients with foot ulcers


eligible ages (years): 5.0-999.0,  All  Insulin Resistance Diabetes Mellitus Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT Family history of type II diabetes  Critically ill patients, patients will congestive heart failure, renal or liver insufficiency Inability to give consent History of poor compliance with physician's recommendations


eligible ages (years): 18.0-80.0,  All  Foot Ulcer Diabetic Foot Skin Ulcer Diabetic Neuropathies Diagnosis of Type I or Type II diabetes mellitus and a glycohemoglobin A1c<12% Minimum of one neuropathic, diabetic ulcer meeting the following stage III or IV, located on the distal lower extremity, between 1 and 15 square centimeters No exposed bone at the ulcer site No osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Adequate arterial circulation to the foot New ulcers must be meet the following full-thickness ulcer (Stage III or IV), located on feet or ankles, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Recurrent ulcers must meet the following stage II, III or IV, no exposed bone at the ulcer site, no osteomyelitis affecting the area of the ulcer unless receiving aggressive treatment with expectation of cure Females must be postmenopausal, surgically incapable of childbearing, or using an acceptable method of birth control and have negative pregnancy test  Hypersensitivity to Gel or one of its components Presence of more than two full-thickness diabetic ulcers on either lower extremity presence of an active systemic or local cancer or tumor of any kind Use of topical antibiotics, antiseptics, enzymatic debriders, or any other agents on the selected ulcers, within the seven days preceding randomization Active rheumatic or collagen vascular disease or pre-existing conditions or diseases which may interfere with the evaluation of safety or efficacy of Regranex Systemic corticosteroid maintenance therapy, immunosuppressive or chemotherapeutic agents within 14 days prior to first study drug application or are likely to receive one of these therapies during study participation Radiation therapy that included the distal lower extremity, at any time in patient's life Charcot deformity (rocker bottom foot)


eligible ages (years): 18.0-999.0,  All  Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 People with Type I or Type II Diabetes Years or Older


eligible ages (years): 16.0-80.0,  All  Wounds Patients with a poorly healed wound, in which skin graft is clinically indicated  Skin infection Vital signs unstable


eligible ages (years): 30.0-999.0,  All  Foot Ulcer Diabetes Provision of a written informed consent at the enrolment visit Men or women above 30 years of age Fertile women need to take contraceptives or have to be sterilised Diagnosed with any diabetes mellitus type 1 or type 2 Present foot ulcer with an ulcer duration <= 12 months  Intolerance to statins at any time in the past Unwillingness to participate A history of alcohol or drug abuse within the last 2 years Foot ulcer with the etiology from vasculitis, pyoderma gangrenosum, angiodermatitis necroticans (hypertensive ulcer), necrobiosis lipoidica, hydrostatic pressure/venous insufficiency or any neoplasms (basalioma, kaposis sarcoma, squamous cell carcinoma etc) History of drug-induced hepatitis or previous liver enzyme elevations (> 3 times the upper limit of normal) while taking statins History of drug-induced creatine phosphokinase (CPK) > 3 times the upper limit of normal Critical limb ischemia that requires re-vascularisation procedures within 2 months Brachial-ankle index < 0.5 Other serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient's safety or successful participation in the trial Any clinically significant abnormality identified in the enrolment medical history, physical examination, laboratory test which, in the judgement of the investigator, would preclude safe completion of the study


eligible ages (years): 18.0-999.0,  All  Foot Ulcer years of age or older Ambulatory (i.e. walking is the primary method of mobilization. Crutches, walker, walking frame or other ambulation aids are permitted) Diagnosed Type 2 diabetic (i.e. not juvenile onset) Have a DFU on the plantar surface of either foot Have a DFU of >4 wks but <6 months duration Willing and capable of cooperating to the extent and degree required by the study protocol  Be < 1cm2 or >10cm2 in area, by planimetry Demonstrate overt signs of infection Be located on the dorsal, lateral, or posterior heel area of the foot (Change 2, Amendment 1) Have visible exposed bone or tendon Have an adjacent thermal injury or wound of an etiology other than diabetes Be within 5 cm of any other wound, regardless of etiology Have received enzymatic debriding agents in the past 7 days Have received topical antibiotic therapy in the past 7 days Be less than 1 cm2 or exceed 10cm2 in area by planimetry, after debridement Have exposed bone or tendon, after debridement


eligible ages (years): 0.0-999.0,  All  Pressure Ulcers Bacteremia Patient in the complex nursing department With contaminated pressure ulcers Going to have a debridement procedure  Penicillin sensitivity Bacteremia that does not react to the antibiotic treatment


eligible ages (years): 18.0-80.0,  All  Diabetic Polyneuropathy Diabetic Foot Ulcer Diabetes Foot Infection diagnosis of diabetes by WHO ability to provide informed consent 80 years of age  patients with open ulcers or open amputation sites active Charcot arthropathy severe peripheral vascular disease active foot infection dementia -impaired cognitive function- history of drug or alcohol abuse within one year of the study other conditions based on the PI’s clinical judgment


eligible ages (years): 18.0-80.0,  All  Neuropathic Foot Ulceration in Individuals With Diabetes confirmed diabetes neuropathic ulcer grade 1/2 (wagner scale) confirmed sensory neuropathy  osteomyelitis patients unable to walk life threatening co-morbidity ankle/brachial index , 0.4


eligible ages (years): 18.0-80.0,  All  Diabetes Clinical diagnosis of Type 1 or 2 Diabetes most recent A1C greater than or equal to 7.0% Referred to the Diabetes Improvement Program for diabetes care Age 18-80 English Speaking  Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener, or Patients with a diagnosis of significant dementia, psychosis, or blindness


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Ulcer Patient is greater than 18 years of age Patient has Type I or Type II Diabetes Patient must be able to understand English (self or translator) and give written, informed consent Patient has a plantar forefoot ulcer(s) beneath metatarsal head or toe ulcer which has been present for at least 4 weeks, and has received best practice care Evidence of adequate arterial perfusion: Toe plethysmography reading of mmHg or Transcutaneous oxygen measurement of ≥ 30mmHg Patient is appropriately offloaded (contact cast, pneumatic walking cast) Infection and/or osteomyelitis have been ruled out or are being treated Patients must have a platelet count greater than150,000/mm3 Orthopedic assessment has been completed to rule out mechanical source of ulceration  TcPO2 <30 mmHg and/or toe plethysmography readings of less then 45 mmHg Limb ischemia requiring re-vascularization or impending amputation Untreated wound infection or osteomyelitis Bleeding disorders, hemophilia, sickle cell disease, thrombocytopenia,and leukemia or blood dyscrasias Anemia with hemoglobin level less than 100 g/L will be included as criteria Patient is taking immunosuppressive agents (e.g. corticosteroids, chemotherapeutic agents, transplant medications) Current treatment for malignancy or neoplastic disease or collagen vascular disease Patient has a highly communicable disease or diseases that may limit follow up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis) Patients taking anticoagulants like heparin or coumadin or others which may hinder in clot (thrombin) formation


eligible ages (years): 18.0-79.0,  All  Colitis, Ulcerative Active ulcerative colitis, CAI greater than or equal to 4  Antibiotics in the last 3 months Probiotics Alteration to medications in last 3 months


eligible ages (years): 12.0-16.0,  All  Type 1 Diabetes Mellitus Age of adolescent 12-<17 years Type 1 diabetes for >2 years Living in a home environment English reading ability at 5th grade level or above Established diabetes care at participating site Working telephone service Intent to remain living in same region for next 18 months -  Presence of another chronic systemic disease Inpatient psychiatric treatment of patient or caregiver in prior 6 months Current outpatient treatment of psychosis, major depression or substance use disorder in parent/caregiver


eligible ages (years): 18.0-999.0,  All  Foot Ulcer, Diabetic Diabetic Angiopathies age over 18 years type I or II diabetes mellitus diagnosed (ADA 1998) for more than 3 years presence of at least one cutaneous ulcer distal to the knee, not involving deep tissues (stages I and II of Wagner’s classification ) and existing for at least three months giving their written informed consent  hypersensibility to heparin or pig derivatives body weight lower than 35 kg presence of clinical signs of infection that did not resolve in spite of oral antibiotics anticoagulant therapy severe impairment of renal or hepatic function bleeding disorder active peptic ulcer arterial hypertension with poor control pregnancy or lactation terminal illness or a prognosis of survival under three months


eligible ages (years): 21.0-999.0,  All  End Stage Renal Disease Hemodialysis Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)  Temporary catheter dialysis access, inability to be compliant with study medication


eligible ages (years): 18.0-90.0,  All  Venous Ulcer Patients of any race and are between 18 and 90 years of age Patients that are able to understand and are willing to give written informed consent Patients that have a non-healing open venous ulcer for at least one month Patients that have greater than 50% of the ulcers surface area covered with non-viable tissue such as fibrin slough, dry crust or a combination of both Patients that have the clinical signs and symptoms of venous ulceration such as varicosities, hyper pigmentation, stasis dermatitis, lipodermatosclerosis, and edema Patients that have a venous ulcer with a surface area of greater than or equal to 1.5 cm2 Patients that have an ankle to brachial index (ABI) > 0.70  Study wound (target ulcer) etiology is other than venous insufficiency Patient has peripheral arterial disease as determined by the following Ankle/Brachial Index < 0.7 (ulcerated leg), evidence of intermittent claudication Patient has the presence of any of the following in the area of the ulcer: cellulitis, osteomyelitis, and ulcer with exposed bone, tendon or fascia Patient has a known hypersensitivity to dressing components Patient is receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy where in the investigator’s opinion could interfere with wound healing  Patient is known to have uncontrolled diabetes mellitus (as defined by the investigator) Patient is known to have immunodeficiency disorders that interfere with wound healing Patient has a history of sickle cell anemia, thalassemia, vasculitis, rheumatoid arthritis, lupus erythematosus, polyarteritis nodosa, scleroderma or any connective tissue or collagen vascular disorder Patient has wounds that have been treated with an investigational product within the past thirty days Patient has not signed the informed consent


eligible ages (years): 18.0-85.0,  All  Type 2 Diabetes Clinical diagnosis of Type 2 Diabetes most recent A1C >= 7.5% Referred to the Diabetes Care Program for diabetes care Age 18-85; 5. English Speaking  Patients with corrected visual Acuity >20/50 using a Rosenbaum Pocket Vision Screener Patients with a diagnosis of significant dementia, psychosis, or blindness


eligible ages (years): 45.0-69.0,  All  Diabetic Foot Ulcer A diabetic foot ulcer corresponding to grade 2 No history of deep venous thrombosis and no hemorrhage in ulcer  Significant loss of protective sensation Hemorrhage during treatment Vertigo No completion of treatment


eligible ages (years): 18.0-80.0,  All  Diabetic Foot diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure ulcer present for at least 2 weeks and measuring 1 cm2 diminished sensesation on target extremity/foot ulcer is not infected Type 1 or 2 diabetes with adequate glycemic control Adequate vascular supply to the target extremity  Charcot foot Non-neuropathic ulcers Skin cancer within or adjacent to the target ulcer Osteomyelitis or an infected ulcer Clinically significant medical condition that would impair wound healing Females who are pregnant Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy


eligible ages (years): 12.0-999.0,  All  Keloid Male or females, in good health, and at least 12 years of age Individuals with 2 or more keloids on the trunk, arm, leg, and neck between 0.5 and 2 cm in length Individuals who are willing and able to participate in the requirements of the study, including signing the informed consent In the opinion of the investigator, the 2 keloids can be excised in a similar manner and closed properly with the two techniques and will benefit from the procedure In the opinion of the investigator, the keloid could benefit from surgical procedure  Individuals with keloids that do not fit into the criteria Individuals who are planning pregnancy, pregnant, or breast feeding Individuals with a history of medical or dermatologic conditions which, in the opinion of the investigator, would put the subject at heightened risk or would limit complicate the study evaluations required by the protocol Individuals who present with excessive body hair in the designed keloid area Individuals with uncontrolled diabetes Individuals with autoimmune disorders (HIV/AIDs, SLE) Subjects who have received keloid treatment within one month of the first day of the study Individuals who plan to receive keloid treatment(s) during the study Individuals who are currently taking prescription or over the counter medication or interventions on a regular basis that as part of their mechanism of action, have the potential to mask an inflammatory reaction. Examples of such medications but are not limited to, corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs), antihistamines, aspirin (81mg or less daily dosage permissible), or other medications that in the opinion of the investigator or designee may expose the subject to heightened risk or complicate the study assessments


eligible ages (years): 10.0-16.0,  All  Type 1 Diabetes a current hemoglobin A1c(HbA1c) of >8.0% an average HbA1c of >8.0% during the past year diagnosed with Type 1 diabetes for at least one year reside in the metro Detroit tri-county area  severe mental impairment/thought disorder non-English speaking patient/parent co-morbid major medical condition such as cystic fibrosis


eligible ages (years): 18.0-999.0,  All  Diabetic Foot Varicose Ulcer Pressure Ulcer Patients who are at least 18 years of age Males and females (provided they are not pregnant or, if of reproductive age, are using contraception) Patients with a venous stasis, diabetic foot or decubitus reference ulcer located between the tibia and foot Patients undergoing surgical debridement of their reference ulcer in the operating room (OR) Patients undergoing their first surgical debridement of the reference ulcer Patients suitable for debridement of their reference ulcer with both and conventional debridement techniques Patients who are able to understand the evaluation and are willing and able to provide written consent to participate in the evaluation  Patients with clinical signs of infection in the reference ulcer (e.g. purulence and / or odour) Patients with haemophilia Patients who have been treated with topical steroids, systemic immunosuppressants (including corticosteroids), anticoagulants or cytotoxic chemotherapy in the last 30 days, or who are anticipated to require such medications during the course of the study Patients known to have Acquired Immunodeficiency Syndrome (AIDS) or known to be infected with Human Immunodeficiency Virus (HIV) Patients who suffer from acute or chronic bacterial, viral or fungal skin diseases that would interfere with wound healing Patients with a known history of poor compliance with medical treatment Patients who have participated in this evaluation previously or are currently participating in another clinical study