eligible ages (years): 0.5-4.917,  All  Malaria, Falciparum Malnutrition Child Age between 6 and 59 months Weight ≥5kg P. falciparum monoinfection confirmed on a thick blood film Parasitic density between 1,000 and 200,000 asexual forms/uL of blood Measured axillary temperature ≥37.5°C or history of fever during the previous 24 hours Severe malnutrition (defined as a weight/height ratio less than -3 z-scores) High probability of compliance with follow-up visits (home is within two hours of walk from the outpatient department, no near-term travel plans, etc..) Consent of a parent or guardian who is at least 18 years of age  Signs of a critical illness as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Signs of severe or complicated malaria as defined by the WHO (WHO (2000) Severe falciparum malaria; Clinical features of severe falciparum malaria in children. Royal Society of Tropical Medicine and Hygiene, 94 (supplement 1), 5-11) Severe anaemia (haemoglobin <5 g/dL) Known history of hypersensitivity to any of the study medications Symmetric oedema in the feet Concomitant febrile illness not originating from malaria, which could alter the outcome of the study (measles, acute lower respiratory tract infection, otitis media, tonsillitis, abscesses, severe diarrhea with dehydration, etc.) History of a full treatment course with the study drug in the past 28 days


A 15 yo girl accompanied by her mother is referred for evaluation by the school. The girl has more than expected absences in the last three month, appears to be constantly tired and sleepy in class. Her mother assures the girl is well fed, and getting the proper sleep at night but admits the girls tires easily when they go out on weekend hikes. Physical examination: BP: 90/60. HR 130/min the only remarkable findings are extremely pale skin and mucosae. Grade 3/6 systolic murmur. Lab tests report Hb: 4.2 g/dL, MCV 61.8 fL, serum iron < 1.8 umol/L and ferritin of 2 ng/mL. Fecal occult blood is negative.

eligible ages (years): 18.0-999.0,  All  Autoimmune Hemolytic Disease (Cold Type) (Warm Type) Newly diagnosed "warm" or "cold" AIHA, defined by symptomatic anemia and positive DAT, in the absence of underlying lymphoproliferative, infectious or neoplastic disease (according to the single Center diagnostic criteria) Idiopathic "warm" or "cold" AIHA relapsed after first line treatment with oral prednisone Aged >18 years ECOG performance status grade 0, 1 or 2 No psychiatric illness that precludes understanding concepts of the trial or signing informed consent Patients who have provided written informed consent prior to study participation, with the understanding that the consent may be withdrawn by the patient at any time without prejudice  Cell or humoral immunologic deficit (congenital or acquired) Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent Active bacterial, viral, or fungal infection requiring systemic therapy HIV or HbsAg positive (with HBV-DNA+) or HCV-Ab positive (with HCV-RNA+) patients History of malignancies within 3 years prior to study entry Concomitant immunosuppressive or cytotoxic treatment Positive pregnancy test. Lactation The presence of associated organ-specific autoimmune diseases do not constitute  Previous splenectomy does not constitute


eligible ages (years): 18.0-75.0,  All  Non ST Segment Elevation Myocardial Infarction Unstable Angina ICF signature The research subject must agree about following all instructions and perform the procedures and study visits Men and women over the age of 18 and below the age of 75 History of angina of rest with a minimum duration of 20 minutes in the last 24 hours at the beginning and at least for 10 days Patient Randomization up to 6 hours after the arrival at the emergency sector Evidence of or unstable angina due to one or more of the following Dynamic alterations on the T-wave (ST-segment depression or elevation > 1 mm, and/or T-wave inversions which are solved at least partially when the symptoms are relieved) or 2. Unevenly ST-segment (depression or elevation) in a transitional way under continuous derivations (V1+V2 or V3+V4 or V5+V6 or D1+AVL or D2+D3+AVF) or 3. Biochemical alteration on the myocardial necrosis markers (CKMB mass, troponin T or I and CPK), with the appearance of enzymatic curve, characterizing myocardial injury or 5. Pulmonary Edema; or 6. Angina associated to murmur of mitral regurgitation; or 7. Angina with heart sound to cardiac auscultation or throes; or 8. Angina with hypotension  derivation-ECG with persistent ST-segment elevation Diagnosis of angina by secondary cause (e.g., anemia, fever, hypovolemia, dehydration, use of cocaine) Use of non-fractionated heparin or low-molecular weight heparin in the prior 48 to the randomization Concomitant diseases, such as severe renal failure (creatinine clearance lower than 30ml/min.) and hepatic, or other significant comorbidities under investigator judgment Recent hemorrhagic cerebrovascular accident (last 12 months) Patient scheduled for cardiac surgery of myocardial revascularization Use of drugs, alcohol abuse Pregnancy or lactation Recent neurosurgery or ophthalmic surgery (last 3 months) History or diagnosis of coagulopathy


eligible ages (years): 0.0-1.0,  All  Anemia Chronic Kidney Disease Girls and boys between birth and < 1 year of age at the time of enrollment Body weight ≥ 3 kg at screening and enrollment Diagnosis of chronic kidney disease stage 3 to 5 with an estimated Glomerular Filtration Rate < 60 mL/min/1.73m2 without dialysis using the updated Schwartz Equation at screening; OR on dialysis at screening Hemoglobin ≤ 9.0 g/dL within 7 days prior to enrollment Transferrin saturation ≥ 20% at screening  Premature girls and boys (< 37 weeks of gestation, counting from the first day of the mother's last menstrual period) Peritoneal dialysis subjects with an episode of peritonitis within 30 days prior to enrollment History of cardiovascular events or thromboembolism History of upper or lower gastrointestinal bleeding History of seizures Active liver disease or history of liver disease Uncontrolled hypertension defined as stage 2 hypertension or greater. This is defined as a systolic or diastolic blood pressure value greater than the 99th percentile + 5 mmHg for a subject's age Major surgery 12 weeks prior to enrollment Red blood cell transfusions 12 weeks prior to enrollment Use of any erythropoiesis-stimulating agent within 12 weeks prior to enrollment


eligible ages (years): 18.0-90.0,  All  Skin Closure of Surgical Incisions by Tissue Glue vs Suture Living kidney donor with informed consent Approved comprehensive work-up/evaluation at local hospital  Allergy towards acrylate or similar chemicals Unable to communicate in norwegian language


eligible ages (years): 12.0-999.0,  All  Iron Deficiency Non-pregnant adolescent subjects of reproductive age with low iron stores with or without mild anemia, who are otherwise healthy, will be enrolled in the study  Pregnant, lactating, severe anemia, low BMI would be excluded


eligible ages (years): 0.0-72.0,  All  Congenital Heart Disease all consecutive live newborn infants between 6-72hours of age  declining the screening early discharge before the screening missing


eligible ages (years): 10.0-16.0,  All  Myopia Visual acuity: 20/20 or better in each eye Spherical error ranging from +0.5 D to -6.0 D and astigmatism less than 1.5 D in each eye, anisometropia less than 1.0 D between the two eyes Contact lens No strabismus, amblyopia and any other ocular or systematic diseases that may affect refractive development  Currently using other interventions to control myopia progression (acupuncture, massage, drugs, ear needles and so on) Unable to cooperate with the ocular examination and questionnaire survey


eligible ages (years): 12.0-17.0,  All  Acne Quality of Life Between 12 and 17 years of age diagnosis of acne by a pediatric dermatologist ability to read and understand English age appropriate development  • developmental delay


eligible ages (years): 0.5-0.917,  All  Iron Deficiency Anaemia Stunting Aged 6-11 Residing within the project catchment area, and plan on remaining in the same household for the 12 month study duration Parent/guardian willingness to give consent for the child's participation in the study  Weight-for-height Z score <3 SD Mid-upper arm circumference < 11.5 cm Presence of bilateral oedema Severe anaemia (Hb < 7.0 g/dl) HIV positive


eligible ages (years): 16.0-70.0,  All  Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0) Diagnosis of HbSS, or HbSβ-thalassemia0, confirmed by hemoglobin analysis Males and females age 16 years to 70 years old Greater than 2 episodes of pain in the last 12 months On a stable dose of hydroxyurea for at least 2 months and a stable hemoglobin  Judged not likely to be study compliant by his/her hematologist History of adverse reaction to montelukast or any of the components of montelukast Have used medications known to interact with montelukast such as rifampin, phenobarbital, and gemfibrozil within 4 weeks of enrollment Currently being treated with a leukotriene antagonist (montelukast or zileuton) or have used montelukast/zileuton within the last 60 days Chronic blood transfusion therapy defined as regularly scheduled transfusions Hemoglobin A greater than15% on hemoglobin analysis Individuals with a current physician diagnosis of asthma (within last 12 months) or requires continuous supplemental oxygen, or predicted or current use of asthma medications (inhaled corticosteroids, but participants taking bronchodilators will be allowed to participate) Current participation in another therapeutic trial for SCD Known current pregnancy Known history of HIV


eligible ages (years): 0.0-15.0,  All  Malnutrition Anemia household with infant < 12 mo or adolescent 10-15 y Living in selected communities of Upper Manya Krobo District (Ghana)  infant or adolescent has medical condition that limits dietary intakes or growth


eligible ages (years): 18.0-999.0,  All  Sickle Cell Disease Sickle Cell Anemia SCD Patients must have one of the following inherited hemoglobin gene disorders Hemoglobin SS Hemoglobin SC Hemoglobin S-Beta-zero-Thalassemia or Hemoglobin S-Beta-plus Thalassemia Disease Morbidity For matched sibling donor grafts (low-risk e.g., matched sibling donor), patients must have evidence for morbid disease that has failed conventional therapy 2 or more painful episode/year (requiring Emergency Department or inpatient care) x 3 years or 2 or more diagnoses of Acute Chest Syndrome within 5 years, or 2-year mortality 5-10%  eGFR <50 ml/min ≥2.0 liter-per-minute pm home oxygen requirement An estimated Left Ventricular Ejection Fraction ≤40% (echo or MUGA) Hepatic cirrhosis (Biopsy Proven) HIV positive, ineligible because of the increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated Red cell alloimmunization to a degree that precludes extended transfusion Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant or breastfeeding women are excluded from this study because the immunomodulatory treatment, preparative regimen, and anti-GVH therapy contain agents with the potential for teratogenic or abortifacient effects. Further, this treatment, if indicated, is for a chronic condition, and can be delayed until the pregnancy has been successfully concluded. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study Subjects must not have evidence for impaired liver function due to iron overload, +/ hepatitis. Patients will be evaluated by hepatology if ferritin >1500, if history of hepatitis, or ALT/ALP are >1.5 X ULN


eligible ages (years): 0.0-0.014,  All  Heart Murmurs Mitral Valve Prolapse Systolic Murmurs any premature baby or newborn parental approval for study participation


eligible ages (years): 16.0-999.0,  All  Autoimmune Hemolytic Anemia Patients diagnosed with primary warm Autoimmune Hemolytic Anemia Secondary Autoimmune Hemolytic Anemia (infections, hemopathy, systemic diseases) Naive to any treatment for hemolytic anemia or in relapse Older than 16 years of age Able to understand written and spoken French who have provided written informed consent • for Persons without an auto-immune disease, or cancer or an active infection Older than 16 years of age Able to understand written and spoken French  Cold agglutinin disease Pregnant women Persons not covered by national health insurance Non-Inclusion controls Persons treated with corticoids or immunosuppressants Pregnant women Persons not covered by national health insurance


eligible ages (years): 0.654-0.788,  All  Anemia Iron Deficiency Neonatal Jaundice Late preterm or term pregnancy (gestational age 34 to 41 weeks) Vaginal delivery  Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures


eligible ages (years): 18.0-999.0,  All  Anemia Critical Illness Hospitalized for 5 Days or More Hospitalized man/woman in reanimation unit for at least 5 days Age ≥ 18 years old Patient having an anaemia such as defined by the WHO (World Health Organization) (for man: Hemoglobin < 13 g/dl, for woman: Hemoglobin < 12 g/dl) Signed inform consent by the patient or a close person Subject affiliated to a national health insurance  Known iron metabolism pathology (such as primitive or secondary hemochromatosis, …) Chronic anaemia (Hemoglobin ≤ 10 g/dl for more than 3 months) Current chemotherapy Patient having an organ transplant Expected survival < 28 days post Intensive Care Unit discharge Pregnancy Patient deprived of freedom, by judicial or administrative order Major protected by the law Contra-indication to the injectable iron treatment (allergy to ferric carboxymaltose, infection derivates (bacteriamy < 48 hours) untreated) Non speaking French patient, or patient unable to answer a questionnaire because of any neurologic disorder (stroke, brain trauma….)


eligible ages (years): 18.0-999.0,  All  Autoimmune Hemolytic Anemia Adults (18 years old) wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3) Absence of infection or other hematologic disease wAHAI not responding to conventional steroids despite a dose over 10 mg No treatment with rituximab for a minimum of 6 months Signed informed consent form  Less than 18 years old Cold AHAI IL2 allergy Chemiotherapy or immunosuppressive treatment Treatment with rituximab for less than 6 months Neoplasia or hematologic malignancy Aplastic anemia Neutropenia ≤ 1000 mm3 Infection Hepatitis B or C


eligible ages (years): 0.083-0.25,  All  Biliary Atresia persistent yellow skin or sclera, pale stool (in severe cases, clay-like), and hepatomegaly increased serum bilirubin (progressively or no decline after increase), increased total bilirubin (TBil) dominated by increased direct bilirubin (DBil) (>60%) elevated liver enzymes ultrasound confirmation of poor gallbladder filling and signs of liver fibrosis with radionuclide imaging confirmation of obstructed biliary excretion  concomitant cardiovascular or abdominal organ malformations


eligible ages (years): 0.0-18.0,  All  Heart Murmurs Mitral Valve Prolapse Systolic Murmurs outpatient parental approval for study participation


eligible ages (years): 12.0-17.0,  All  Cancer Teenagers at the ages 12-17 Four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting The specific type of chemotherapy may vary across the four/five consecutive courses but shall one of the following moderate and/or highly emetogenic types of chemotherapy Moderate emetogenic chemotherapy Carboplatin Cyclophosphamide <1500 mg/m2 Cytarabine >1 g/m2 Daunorubicin Doxorubicin Epirubicin  Previous and/or acute psychiatric diagnosis Cognitive and mental deficits or impaired functioning


eligible ages (years): 18.0-65.0,  All  Nicotine Dependence Have no known serious medical conditions Are 18-65 years old Smoke an average of at least 10 cigarettes per day Have smoked at least one cumulative year Have an expired air CO reading of at least 10ppm Are able to read and understand English Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study Participation in any other nicotine-related modification strategy outside of this protocol Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco Use of e-cigarettes other than the ones provided during the study  Intent to quit smoking with FDA approved pharmaceutical products within the next 90 days Hypertension (systolic >160 mm Hg, diastolic >100 mm Hg. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety Coronary heart disease Lifetime history of heart attack Clinically significant cardiac rhythm disorder (irregular heart rhythm) Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source) Clinically significant cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure) Clinically significant liver or kidney disorder (except kidney stones, gallstones) Clinically significant gastrointestinal problems or disease Active ulcer in the past 30 days


eligible ages (years): 18.0-999.0,  All  Warm Antibody Autoimmune Hemolytic Anemia Subject must have had a diagnosis of primary or secondary warm antibody AIHA Must have previously received at least 1 prior treatment regimen for AIHA and have evidence of relapse  Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria Subject with a platelet count of < 100,000/μL Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg


eligible ages (years): 18.0-120.0,  All  Atypical Hemolytic Uremic Syndrome Thrombotic Thrombocytopenic Purpura Microparticles Microangiopathic Hemolytic Anemia Patients with MAHA, TTP, and/or aHUS  Prisoners


A previously healthy 8-year-old boy presents with a complaint of right lower extremity pain and fever. He reports limping for the past two days. The parents report no previous trauma, but do remember a tick bite during a summer visit to Maryland several months ago. They do not remember observing erythema migrans. On examination, the right knee is tender and swollen. Peripheral WBC count and SRP are slightly elevated.

eligible ages (years): 0.0-999.0,  All  Lyme Disease Tick-Borne Diseases Ferry passengers traveling to Nantucket Island  Foreign (non-U.S.) residence


eligible ages (years): 18.0-65.0,  All  Lyme Disease You may be eligible for this study if you Are between 18 and 65 years of age Are a resident of Long Island or greater NY metropolitan area Are fluent in English Have a history of Lyme Disease Have completed antibiotic treatment for Lyme Disease 6 or more months before starting the study Have severe fatigue Are not pregnant or planning to be pregnant  You will not be eligible for this study if you Have or have had major medical, neurologic, or psychiatric disorder Have had prior chronic pain, fatigue, or recurrent severe headaches before the onset of Lyme Disease Have had Fibromyalgia Syndrome Have a history of sleep apnea, narcolepsy, or other serious sleep disorder Have a learning disability Have had head trauma requiring hospitalization Have symptomatic gallbladder disease Are anemic Abuse alcohol or illicit drugs


eligible ages (years): 18.0-999.0,  All  Lyme Disease You may be eligible for this study if you Are at least 18 years of age Are seronegative for antibodies against B. burgdorferi antigens by Western Blot at enrollment Have documented history of acute Lyme disease Have had a rash (erythema migrans) that resembles a bullseye. This skin aberration usually occurs after a tick bite in late spring, summer, or early fall and is sometimes accompanied by fatigue, fever, headache, mild stiff neck, arthralgia or myalgia Have had one or more clinical features typical of Lyme disease acquired in the United States (see technical summary) Have had one or more of the following symptoms and conditions that have persisted for at least 6 months (but less than 12 years) and are not attributable to another cause or condition: a) widespread musculoskeletal pain and fatigue that began coincident with or within 6 months following initial infection with B. burgdorferi. b) certain neurologic symptoms including memory impairment and nerve pain, beginning within 6 months following initial infection with B. burgdorferi Have had a physician-documented history of prior antibiotic treatment with a currently recommended antibiotic regimen  You will not be eligible for this study if you Have previously enrolled in this study Are pregnant, lactating, or unable to use birth control measures during the treatment period of this study Are taking chronic medication that could interfere with evaluation of symptoms Are taking or have taken various medications that could interfere with the evaluation of symptoms (see technical summary) Are hypersensitive to ceftriaxone or doxycycline Have active inflammatory synovitis Have another disease that could account for symptoms of acute Lyme disease Have another serious or active infection Are unable to tolerate an IV


eligible ages (years): 13.0-999.0,  All  Lyme Disease Screening Age greater than or equal to 13 years old Suspect of suffering from Lyme disease Post-Treatment Lyme Disease Syndrome (PTLDS): For the purposes of this study, PTLDS is defined as occurring in male or female patients age 13 and above who have been diagnosed with confirmed Lyme disease, have received recommended antibiotic therapy and have persistent or relapsing symptoms and/or signs for at least six months after therapy. They also should have no other documented explanation for their signs and symptoms and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC (IgG immunoblot is considered positive if five of the following 10 bands are present: 18 kDa, 21 kDa (OspC), 28 kDa, 30 kDa, 39 kDa, 41 kDa (Fla), 45 kDa, 58 kDa (not GroEL), 66 kDa, and 93 kDa) Lyme arthritis controls: For the purposes of this study, Lyme arthritis is defined as occurring in an otherwise healthy male or female aged 18 and above who have intermittent episodes of arthritis involving one or few joint, without any other cause being documented, and have positive serum antibodies to B.burgdorferi confirmed by Western blot according to the CDC criteria Recovered Controls: For the purposes of this study, a recovered control is defined as an otherwise healthy male or female aged 18 and above who has had Lyme disease, fulfilling the CDC Lyme Disease National Surveillance Case Definition and who had received accepted antibiotic treatment for Lyme disease (at least 3 months since the end of antibiotic therapy before protocol evaluation) and who are currently asymptomatic Seropositive Controls: For the purposes of this study, a serpositive control is defined as an otherwise healthy male or female aged 18 and above who has positive serum IgG antibody to B.burgdorferi by Western blot according to the CDC and are asymptomatic and who recall no episodes of disease compatible with Lyme infection and have not received antibiotic therapy for Lyme disease OspA vaccinated control: For the purposes of this study, a OspA vaccinated control is defined as an otherwise healthy male or female aged 18 and above who has received at least two doses of the OspA vaccine for Lyme disease (Lymerix [R]). These controls may have a positive ELISA for B.burgdorferi but a negative (or unreadable) IgG western blot Multiple sclerosis controls: For the purposes of this study, a multiple sclerosis control is defined as an otherwise healthy male or female aged 18 and above with relapsing-remitting or progressive multiple sclerosis as defined by the Clinical Trial Committee of the National Multiple Sclerosis Society and no evidence of prior exposure to B.burgdorferi as indicate by negative history for Lyme disease and negative Western blot for B.burgdorferi in the serum by the CDC criteria. Patients should have a Kurtzke or Expanded Disability Status Scale (EDSS) between 1 to 5 Healthy Volunteers: For the purpose of this study, a healthy volunteer is defined as healthy male or female, age 18 and above, with no history compatible with acute or chronic Lyme disease and negative western blot to B.burgdorferi in the serum by the CDC criteria  General Age less than 18 (less than 13 for patients with chronic Lyme disease) Weight less than 70 Lb (35 kg) Pregnancy or lactation Women with childbearing potential who are sexually active and unwilling to use effective contraception Clinically significant laboratory abnormalities including positive test for syphilis (RPR), HBsAg, anti-HCV, anti-HIV Chronic medication use will be evaluated in a case-by-case basis Not able to understand all of the requirements of the study or unable to give informed consent and/or comply with all aspects of the evaluation FOR PTLDS AND LYME In addition to the general


eligible ages (years): 18.0-999.0,  All  Erythema Migrans Lesions Erythema Migrans Patients Age greater than or equal to 18 years Diagnosis of EM an expanding annular lesion, at least 5 cm in diameter on a person with a history of exposure to the disease Exposure is defined as having been (less than or equal to 30 days before onset of EM) in wooded, brushy, or grassy areas (i.e., potential tick habitats) in an area in which Lyme disease is endemic A history of tick bite is not required The area of the erythema migrans lesion is suitable for biopsy. This excludes biopsies on the face, neck, scalp, and over the tibia Not know to be positive for RPR, HIV, HBsAg or HCV Able to give consent Healthy Volunteers  Patients Antibiotic therapy for the current episode of Lyme disease Oral corticosteroids within the past 2 weeks History of severe skin disease (such as psoriasis, atopic dermatitis) in the last year Diagnosis of diabetes, active cancer, or autoimmune diseases Investigational drugs in the past month History of forming large thick scars after skin injuries or surgery History of excessive bleeding after cuts or procedures or on anticoagulation Use of steroid cream/ointment at the rash Healthy Volunteers


eligible ages (years): 18.0-999.0,  All  Lyme Neuroborreliosis Neurological symptoms and/or findings consistent with neuroborreliosis and at least one of the following fulfilled Intrathecal production of borrelia antibodies White cell count in cerebrospinal fluid (CSF) > 5/mm3 Significant rise in borrelia antibodies in two serum samples collected from a patient with at least 3 weeks interval Verified acrodermatitis chronica atrophicans  Allergy to the contents in the medication, or earlier type I reaction to penicillin Treatment with cephalosporins, penicillin or tetracyclins during the last 14 days Pregnancy or breastfeeding Age < 18 years


eligible ages (years): 18.0-999.0,  All  Encephalitis, Tick-Borne Subjects who participated in Study 223 will be eligible for participation in this study if they understand the nature of the study, agree to its provisions and provide written informed consent they received the first booster vaccination with FSME-IMMUN 0.5ml during the course of study 223 blood was drawn after their first booster vaccination in Study 223  Subjects will be excluded from participation in this study if they received any TBE vaccination since their first booster vaccination with FSME-IMMUN 0.5ml have a history of infection with or vaccination against other flaviviruses (e.g. dengue fever, yellow fever, Japanese B-encephalitis) since their first booster vaccination with FSME-IMMUN 0.5ml are known to be HIV positive (a special HIV test is not required for the purpose of the study) since their first booster vaccination with FSME-IMMUN 0.5ml have a known or suspected problem with drug or alcohol abuse (> 4 liters wine / week or equivalent level of other alcoholic beverages) Subjects will not be eligible for booster vaccination if they are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME-IMMUN 0.5ml outside the scope of a clinical trial) suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions are females of childbearing potential and are pregnant or breastfeeding before the booster vaccination (positive pregnancy test result at the medical examination before the booster vaccination) have shown an allergic reaction to one of the components of the vaccine since their first booster vaccination in Study 223


eligible ages (years): 7.0-12.0,  All  Lyme Disease Child age 7-12 and their parents living in the selected endemic areas No exclusions


eligible ages (years): 15.0-999.0,  All  Nervous System Lyme Borreliosis erythema migrans within 4 months before neurologic involvement and pleocytosis in patients >15 years old  pregnancy lactation history of adverse reaction to a beta-lactam antibiotic


eligible ages (years): 15.0-999.0,  All  Erythema Chronicum Migrans solitary erythema migrans in patients > 15 years  a history of Lyme borreliosis in the past pregnancy or lactation immunocompromised status serious adverse event to doxycycline taking antibiotic with antiborrelial activity within 10 days multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis


eligible ages (years): 15.0-999.0,  All  Suspected Early Lyme Neuroborreliosis age >15 years erythema migrans in 4 months period before neurologic symptoms normal CSF cell count absence of more defined clinical symptoms or signs for CNS involvement (radicular pain, meningeal signs, peripheral facial palsy)  pregnancy lactation allergy on doxycycline and ceftriaxone immune deficiency


eligible ages (years): 18.0-999.0,  All  Rheumatoid Arthritis adult patients >/= 18 years of age active moderate or severe rheumatoid arthritis of <10 years duration with inadequate response to methotrexate or anti-TNF on methotrexate treatment for at least 10 weeks, at least 8 weeks on stable dose patients receiving oral corticosteroids and/or NSAIDs should be at stable dose for 4 weeks  rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA functional class IV by ACR classification history of inflammatory joint disease other than RA previous treatment with cell-depleting therapies, abatacept or rituximab active current or history of recurrent infection, or any major episode of infection requiring hospitalization or treatment with iv antibiotics <4 weeks or oral antibiotics <2 weeks prior to screening


eligible ages (years): 17.0-65.0,  All  Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy  Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative


eligible ages (years): 10.0-999.0,  All  Anaplasmosis Tick-borne Disease Ehrlichia patient with at least one of following symptoms : fever or muscular pain or articular pain or respiratory signs or neurological signs or meningitis or erythema occurring during the three weeks after a tick bite- patient with fever with at least one of following : thrombocytopenia, leucopenia, hepatitis, without any other cause that can explain these abnormalities patient with tick-borne encephalitis, or primary stage Lyme borreliosis  children less that 10 years pregnancy patients with an other diagnosis that can explain clinical symptoms or biological abnormalities antibiotherapy with cyclins during the days before


eligible ages (years): 18.0-999.0,  All  Tick-Borne Encephalitis Encephalitis, Tick-Borne Tick-Borne Disease Glycoprotein E, Flavivirus NSI Protein, Flavivirus All subjects must meet the following at study entry Be engaged in activities that place them at potential risk of occupational exposure to TBEV in its viable form at one of the participating intramural laboratories of NIAID Be 18 years of age or older at the time of the first immunization Comprehend the study requirements Provide written informed consent to participate in this study Be in good health as determined by the Investigator, based upon medical history and a targeted physical examination Have a stable health status as determined by the Investigator Have access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common use phone serving multiple rooms or apartments) Express availability for the required study period, and ability to attend scheduled visits  The following should be checked at the time of the study entry. If any apply, the subject will not be included in the study The subject must not be participating in any other trial of an investigational drug or vaccine for 1 month prior to the first injection through until 21 days after the third injection. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case by case basis after discussion between the Investigator and the IRB.) The presence on the day of immunization of an oral temperature of > 101.2 degrees F or acute symptoms other than mild severity Active systemic infectious process as determined by review of systems and physical examination. The subject may be enrolled at a later date once the illness has resolved Known immune suppression, such as that associated with human immunodeficiency virus infection, or other condition, to the extent that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine. This information will be obtained by history only. Serologic screening for these diseases will not be performed Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the Investigator to render the potential subject unable/unlikely to report promptly any adverse reactions to the vaccine Current diagnosis of leukemia, Hodgkin s disease, non-Hodgkin s lymphoma, or any other cancer, autoimmune disease such as lupus, which is in and of itself a cause of immunosuppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Currently receiving systemic immunosuppressive chemotherapy or immunotherapy (including glucocorticoids) resulting in immune suppression to the point that, in the opinion of the Investigator, the subject is likely to have a poor response to the vaccine Any neurological condition in which (in the opinion of the Investigator) the integrity of the blood brain barrier may have been compromised Licensed vaccines are not exclusionary but should be given at least 14 days before or after immunization (applies to each of the 3 scheduled TBEV injections) for inactivated vaccines and 30 days before or after immunization with any live vaccines. This is in order to avoid potential confusion of adverse reactions. (Given the nature of the work these study subjects engage in, exemptions to this proscription may be granted on a case-by-case basis after discussion between the Investigator and the IRB.)


eligible ages (years): 18.0-999.0,  All  Lyme Neuroborreliosis patients with typical clinical manifestations of Lyme neuroborreliosis and intrathecal antibody production against Borrelia burgdorferi patients with typical clinical manifestations of Lyme neuroborreliosis and erythema migrans within three months patients with some clinical manifestations of Lyme neuroborreliosis and presence of antibodies against Borrelia burgdorferi bacteria in blood  pregnancy lactation use of any antibiotics two weeks before study treatments begins an allergy to ceftriaxone or doxycycline


eligible ages (years): 0.167-3.0,  All  Urinary Infection Children aged 2 months Non-toilet-trained children Indication to bag urine collection with the following  fever ≥ 38.5 °C unexplained fever and at least 1 of the following for girls and uncircumcised boys, at least 2 for circumcised boys  age ≤ 12 months fever ≥ 48 hours poorly tolerated fever (chills ± cyanosis ± pronounced weakness…)  Parents opposed to the participation of their children in the study Diarrhea Current antibiotic treatment or during the 8 preceding days of the urine collection Genitals / perineal anomaly


eligible ages (years): 8.0-14.0,  All  Duchenne Muscular Dystrophy Diagnosis of Duchenne muscular dystrophy confirmed by at least one of the following Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical presentation consistent with typical DMD Positive gene deletion test (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as "out-of-frame", and clinical presentation consistent with typical DMD Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) definitively associated with DMD, and clinical presentation consistent with typical DMD Age between 5 yrs old (inclusive) Positive Gower sign (indicating ability to rise from the floor & presence of proximal muscle weakness) Able to walk 10 meters in <12 seconds Able to stand upon WBVT plate (with knees flexed) for entire treatment protocol (i.e. 15-minutes) Stable absolute dose of glucocorticoids (i.e. prednisone or deflazacort) for at least 3 months prior  Clinical presentation, genetic testing and/or muscle biopsy consistent with Becker muscular dystrophy History of recent surgery (within past 6-months) History of a recent fracture (long-bone or vertebral) within past 6-months Acute inflammatory processes of lower extremities (e.g. cellulitis, etc) due to risk of pain and/or worsening inflammatory process History of venous thrombosis (theoretically risk of inducing thromboembolic event) History of kidney or bladder stones History of uncontrolled seizures or severe migraines History of cardiac arrhythmia Intracranial pathology or hardware (e.g. ventriculoperitoneal shunt, cochlear implant) Use of any investigational or experimental products within last 6-months and/or concomitant participation in another study


eligible ages (years): 18.0-999.0,  All  Acute Injury of Upper Extremity All new patients (>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) English fluency and literacy Able to take informed consent  Pregnant women


eligible ages (years): 7.0-9.0,  All  Duchenne Muscular Dystrophy Diagnosis of DMD confirmed by clinical history with features before the age of five physical examination elevated serum creatine kinase level absence of dystrophin expression, as determined by immunostain or Western blot (<2%) and/or DNA confirmation of dystrophin mutation Age 7 to 9 years: a lower age limit of 7 years was selected, since in our experience children younger than 7 years are likely unable to cooperate and comply with all of the exercise measures as needed. An upper age limit of 9 years has been set as boys with DMD tend to reach a rapid progression into a late ambulatory phase soon after this age Ambulatory at the time of the first visit, defined as the ability to walk for at least 100 m without an external assistive device and able to climb four stairs Currently using corticosteroids (prednisone or deflazacort) as prescribed by a physician  Contraindication to an MR examination (e.g. aneurysm clip, severe claustrophobia, magnetic implants) Presence of a condition in control subjects or a secondary condition in boys with DMD that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Secondary condition leading to developmental delay or impaired motor control (e.g. cerebral palsy) Secondary condition that impacts muscle function or muscle metabolism (e.g. myasthenia gravis, endocrine disorder, mitochondrial disease) Unstable medical condition (e.g. uncontrolled seizure disorder) Behavioral problems causing an inability to cooperate during testing


eligible ages (years): 18.0-999.0,  All  Tick-borne Encephalitis years or older clinical picture compatible with tick-borne encephalitis clear cerebrospinal fluid cerebrospinal pleocytosis (leucocytes in cerebrospinal fluid >5 x 106/)L positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against tick-borne encephalitis virus positive serum IgG antibodies against Lyme borreliae  isolation of B.burgdorferi sensu lato from cerebrospinal fluid positive intrathecal borrelial antibody production index seroconversion of borrelial IgG antibodies presence of erythema migrans and/or borrelial lymphocytoma in the last month Bannwarth syndrome


eligible ages (years): 18.0-130.0,  All  Lung Cancer Provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures Adults (according to each country regulations for age of majority) Locally advanced (stage IIIB) or metastatic (stage IV) EGFRm NSCLC, not amenable to curative surgery or radiotherapy, with confirmation of the presence of the T790M mutation Prior therapy with an EGFR-TKI. Patients may have also received additional lines of treatment World Health Organization (WHO) performance status 0-2 Adequate bone marrow reserve and organ function as demonstrated by complete blood count, biochemistry in blood and urine at baseline (please refer to IB for guidance) ECG recording at baseline showing absence of any cardiac abnormality as per criterion #6 Female patients of childbearing potential must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to start of dosing. Otherwise, they must have evidence of nonchildbearing potential Male patients must be willing to use barrier contraception, i.e., condoms  Previous (within 6 months) or current treatment with AZD9291 Patients currently receiving (or unable to stop use at least 1 week prior to receiving the first dose of AZD9291) any treatment known to be potent inhibitors or inducers of cytochrome P450 (CYP) 3A4 Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, active infection including hepatitis B, hepatitis C, and human immunodeficiency virus, or significantly impaired bone marrow reserve or organ function, including hepatic and renal impairment, which in the investigator's opinion would significantly alter the risk/benefit balance Patient with symptomatic central nervous system (CNS) metastases who is neurologically unstable or has required increasing doses of steroids to manage CNS symptoms within the 2 weeks prior to start AZD9291 administration Past medical history of ILD, drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD Any of the following cardiac Mean resting corrected QT interval (QTcF) > 470 ms using Fredericia's formula  Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events Any unresolved toxicity from prior therapy CTCAE > grade 3 at the time of starting treatment


eligible ages (years): 0.0-0.019,  All  Microbiota Eczema Atopy Term-born babies (≥ 36 weeks gestational age) (Short) stay on maternal ward or admission to neonatal ward because of antibiotic treatment Signed informed consent by the parents  Congenital illness or malformations Severe perinatal infections for which transfer to the neonatal intensive care unit is needed Maternal probiotic use ≤ six weeks before delivery Insufficient knowledge of the Dutch language


eligible ages (years): 18.0-999.0,  All  Tick Bites Tick-borne Diseases over 18 years of age spending an average of 10 or more hours of outdoor work per week during peak tick season, and completion of written informed consent  pregnancy or a planned pregnancy during the follow-up period (since exposure to an insecticide is involved) non-English speakers, or having a known allergy or sensitivity to insecticides


A 4-year-old girl presents with persistent fever for the past week. The parents report a spike at 104F. The parents brought the child to the emergency room when they noticed erythematous rash on the girl's trunk. Physical examination reveals strawberry red tongue, red and cracked lips, and swollen red hands. The whites of both eyes are red with no discharge.

eligible ages (years): 1.0-17.0,  All  Cardiovascular Diseases Coronary Aneurysm Heart Diseases Mucocutaneous Lymph Node Syndrome Boys and girls who met the CDC for Kawasaki Syndrome. Subjects were excluded if they presented themselves to the participating centers after the tenth day of illness


eligible ages (years): 4.0-12.0,  All  Obsessive-Compulsive Disorder OCD Participants (N = 72) Aged 4-12 years and living within a four-hour commute from NIH Currently meet DSM-IV for OCD Recent onset of symptoms (less than 6 months.) Healthy Controls (N = 60-72) Age and sex matched to ODC participants Must be free of current or past psychopathology  OCD Participants Diagnosis of schizophrenia, schizoaffective, bipolar, delusional, or psychotic disorder; autistic spectrum disorder or pervasive developmental disorder; neurologic disorder other than tics; or rheumatic fever Significant or unstable medical illness Full scale IQ less than 80 Healthy Controls Full scale IQ less than 80 Significant or unstable medical illness


eligible ages (years): 12.0-999.0,  All  Pharyngitis Tonsillitis Give informed consent, assent and patient authorization Age 12 and over A clinical diagnosis of acute pharyngitis or tonsillitis A positive rapid Strep test Can swallow the oral study dosage forms Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active  Chronic or recurrent odynophagia Need for hospitalization or IV antimicrobial therapy Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials Known carrier of S. pyogenes Allergies to penicillin or other beta-lactam antibiotics Any serious illness or concomitant condition that the investigator judges will preclude to the study Seizure disorder Pregnant or nursing Expectation of additional systemic antibacterials would be required for another condition Current drug or alcohol abuse


eligible ages (years): 0.5-12.0,  All  Pharyngitis Give informed consent, assent, and documentation of patient authorization for disclosure of study results Since all patients are below the legal age of consent, assent from the patient must be obtained (as applicable following state regulations) and written informed consent obtained from the parent or legal guardian Age > = 6 months -12 years A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat or difficulty feeding or swallowing or irritability that suggests the presence of a sore throat with at least one of the following Tonsillar or pharyngeal exudate Tender cervical lymph nodes Fever or history of fever treated with antipyretics Odynophagia Uvular edema Pharyngeal Erythema of moderate or greater intensity  Chronic or recurrent (two weeks duration two times per year) odynophagia or enlarged tonsils secondary to viral or proven bacterial etiology The need for hospitalization or I.V. antimicrobial therapy Pharyngitis known or suspected to be due to a pathogen resistant to beta-lactam antimicrobials Patients who are known carriers of S. pyogenes Previous allergy, serious adverse reaction to, or intolerance to, penicillin or any other member of the beta-lactam class of antimicrobials Any serious illness or concomitant condition that the investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other known immunocompromised state


eligible ages (years): 3.0-15.0,  All  Streptococcus Group A All children 3 to 15-years old with pharyngitis who are seen at a participating site will be invited to participate  Subjects whose parents are unable or unwilling to provide informed consent will be excluded from the study Children who are 13 years or older and unable or unwilling to provide informed consent will be excluded form the study


eligible ages (years): 12.0-999.0,  All  Sore Throat Pharyngitis Tonsillitis Informed consent/assent Age 12 and older A clinical diagnosis of acute tonsillitis and/or pharyngitis defined as having the clinical signs and symptoms compatible with tonsillitis and/or pharyngitis, including sore throat and pharyngeal erythema with at least one of the following Odynophagia Tonsillar or pharyngeal exudates Tender cervical lymph nodes Fever or history of fever treated with antipyretics Chills Uvular edema Elevated white blood cell count  Chronic or recurrent odynophagia or enlarged tonsils of obscure etiology More than one episode of acute tonsillitis and/or pharyngitis in the 6 months prior to baseline visit Pharyngitis known or suspected to be due to a pathogen resistant to β-lactam antimicrobials Subjects who are known carriers of S. pyogenes Previous allergies, serious adverse reaction to, or intolerance to penicillin or any other member of the β-lactam class of antimicrobials, including cephalosporins Any serious illness or concomitant condition that the Investigator judges would preclude the study evaluations or make it unlikely that the course of study therapy and follow-up could be completed. This would also Any rapidly progressive underlying disease with a shortened life expectancy The inability to swallow the study dosage form Unable to understand the requirements of the study Neutropenia (<1000 PMNs/mm3) or other immunocompromised state


eligible ages (years): 18.0-999.0,  All  Streptococcal Infections Patients diagnosed with GAS infection/isolation in the past 3 years (2003-2005)


eligible ages (years): 0.5-13.0,  All  Tonsillitis Pharyngitis Age 6 months to less than 13 years of age (<13) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Tonsil and/or pharyngeal erythema and/or exudate Cervical adenopathy Uvular edema Fever  Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Females of childbearing potential (ie, have reached menarche) Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm) Myasthenia gravis Known impaired renal function, as shown by creatinine clearance ≤25 mL/min The subject


eligible ages (years): 13.0-999.0,  All  Tonsillitis Pharyngitis Age equal to or over 13 years For female subjects, the following conditions are to be met Subject is premenarchal or surgically incapable of bearing children Subject is of childbearing potential and all of the following conditions are met Have normal menstrual flow within 1 month before study entry Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and Must agree to use an accepted method of contraception throughout the study (if sexually active) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs  Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm) Known impaired renal function, as shown by creatinine clearance ≤25 mL/min Myasthenia gravis History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins Previous enrollment in this study or previous treatment with telithromycin


eligible ages (years): 3.0-999.0,  All  Pharyngitis Streptococcus Pyogenes Infection Streptococcus Pyogenes Identification sore throat at least two Centor fever > 38 deg C or history of fever enlarged cervical lymph nodes tonsillar exudate lack of cough age 3-14 years  antibiotic treatment in preceding 7 days no informed consent


eligible ages (years): 2.0-11.0,  All  Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Aged 2 to 11 years on the day of inclusion Subject in good health, based on medical history, physical examination and laboratory parameters Provision of Assent Form signed by the subject (for subjects ≥8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent[s]) Subject and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures For a female subject of child-bearing potential (girls post-menarche), avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination, until at least 4 weeks after the last vaccination Documented receipt of yellow fever vaccine since at least one month before the first vaccination  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a female subject of child-bearing potential (girls post-menarche), known pregnancy For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the trial Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current or past alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures


eligible ages (years): 16.0-999.0,  All  Bacteremia lip/tongue piercing for at least six month in situ  pregnancy and lactating women medication with known effects on gingival tissues antibiotic medication in the last six months or need for antibiotic prophylaxis chlorhexidine use in the last six months non-plaque induced gingival disease prior diagnosis of periodontitis


eligible ages (years): 2.0-999.0,  All  Atopic Dermatitis Secondary Infection Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age Skin Infection Rating Scale score greater than or equal to 8 Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian  Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control Allergic to any component of the test medication Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1 Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study Recent alcohol or drug abuse is evident History of poor cooperation, non-compliance with medical treatment or unreliability Participation in an investigational drug study within 30 days of Baseline Visit


eligible ages (years): 1.0-14.0,  All  Hand, Foot and Mouth Disease Clinical diagnosis of severe hand-foot-mouth disease patients according to Hand-Foot-Mouth Disease Treatment Guidelines 2010 issued by China's Ministry of Health; More than 1/3 patients should be diagnosed by etiological examination Less than 48 hours of occurrence of fever and/or occurrence of tetter or herpes Age of 1-14 years Patients or their guardians agree to participate in this study and signed the informed consent form  Complicated with other serious primary diseases in organ such as congenital heart disease, chronic hepatitis, nephritis and blood diseases, etc With history of allergies on traditional Chinese medicine Patients or their guardians suffering from Psychiatric diseases Attending other clinical studies on HFMD after diagnosed


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)


eligible ages (years): 18.0-70.0,  All  Oral Health Oral Cancer Gum Disease Submit to a 24 hour urine cotinine test which will be used to determine smoking status Meet one of the following smoking Non-smoker Does not currently smoke or has no history of smoking or using tobacco related products (cigarettes, cigars, pipe, snuff, or chewing tobacco) or smoking any non-tobacco related products and urine cotinine (less than 100 ng/mL Does not currently smoke but has quit smoking for more than 10 years and smoked less than 1 pack/day of cigarettes when they were actively smoking and has a urine cotinine (less than 100 ng/mL) Smoker Smokes habitually at least 10 cigarettes/day and a urine cotinine level of >1000 ng/mL. Cigar and pipe smokers who smoke at least 10 grams of tobacco daily are also eligible Agree to consume a standardized vitamin and mineral supplement and avoid other nutritional, dietary, or alternative medications/supplements for the duration of the study No history of malabsorptive, gastrointestinal or other metabolic disorders requiring special diet recommendations Body mass index (BMI) between 20 and 35 kg/m2  Have a known allergy to strawberries, corn, and wheat products or those who have never consumed any of these products Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, ileus, IBS), renal insufficiency, hepatic insufficiency, hyper or hypothyroidism, cachexia, morbid obesity, or short bowel syndrome Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, ACTH, growth hormone, insulin) or other endocrine disorders requiring hormone administration Have significant loss of gastrointestinal organs due to surgery, except for appendix Have altered immunity such as chronic inflammatory disease, autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias Heavy alcohol consumers defined as >15 glasses/week (one glass = 1.5 oz. liquor, 5 oz. wine, or 12 oz. beer) Antibiotic use in the last 6 months or on medications that will accelerate or decrease bowel motility Are receiving or in need of dental treatment during the study period Have noticeable open lesions, sores that have not healed for more than 3 months, have had any active oral lesions or maladies within the last month, or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips


eligible ages (years): 0.083-15.0,  All  Invasive GAS Infection Age ≥ 1 month to <15 years at the time of Group 1 : Children hospitalized for invasive GAS infection Subgroup 1A ( N = 75 ): Children with invasive infection without known risk factor  Subgroup 1B (N = 75) : Children with invasive infection with known risk factor  GAS Invasive infections are defined by a) Proved infection : Bacteriological isolation of S. pyogenes from a liquid or a normally sterile site, except from a blister of a simple erysipelas, without necrosis . This is sometimes associated with a shock with multiorgan failure (streptococcal toxic shock syndrome ( STSS )) b ) Probable infection  . Bacteriological isolation of S. pyogenes from a normally non-sterile site ( eg skin, upper respiratory tract ) associated with extensive soft tissue necrosis . Bacteriological isolation of S. pyogenes a site or a biological sample usually non-sterile ( eg skin , upper respiratory tract ) associated with a evocative shock syndrome STSS and no other cause found  Contributing factors for invasive infection are defined by cutaneous effraction (wounds , burn , chicken pox ), the use of corticosteroids or other treatment, immunosuppressive and recent surgery  Group 1: Children with a known immune deficiency unrelated to the risk factors described above Group 2: Children with a known immune deficiency


eligible ages (years): 10.0-999.0,  All  Kawasaki Disease Aneurysm, Coronary Clinical diagnosis of Kawasaki Disease with giant aneurysm Must be older than 10 years old  Subjects ever received coronary artery bypass graft (CABG) surgery Subjects have active hepatitis or persistent abnormal liver function such as elevated GOT and GPT Subjects have the past history of rhabdomyolysis Female subjects are pregnant or plan for child-bearing during study periods


eligible ages (years): 0.0-999.0,  All  Kawasaki Disease (both 1 and 2) All subjects are children who fulfilled the for Kawasaki Disease (American Heart Association criteria) Fever > 5 days, and 4 of the 5 following symptoms Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips) Bilateral non-purulent conjunctivitis Dysmorphous skin rashes Indurative angioedema over the hands and feet Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter) 2. KD patients are treated with IVIG at each hospital after informed contents are obtained  Patients whose symptoms did not full fit the Kawasaki Disease criteria Had an acute fever for < 5 days and >10 days Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography) IVIG treatment at other hospital before refers to study centers Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment The presence of a disease known to mimic Kawasaki disease Previous diagnosis of Kawasaki disease Inability to take aspirin


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


A 65 yo male with no significant history of cardiovascular disease presents to the emergency room with acute onset of shortness of breath, tachypnea, and left-sided chest pain that worsens with inspiration. Of note, he underwent a right total hip replacement two weeks prior to presentation and  was unable to begin physical therapy and rehabilitation for several days following the surgery due to poor pain management. Relevant physical exam findings include a respiratory rate of 35 and right calf pain.

eligible ages (years): 50.0-80.0,  All  Osteoporosis 80 years of age, inclusive years since last menses Dx femoral neck osteoporosis No vertebral fractures  Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE


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): 18.0-999.0,  All  Sepsis Adult patients with severe sepsis Presence of a suspected or proven infection One or more sepsis-associated organ failure  Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country Platelet count <30,000/mm3 Are receiving therapeutic heparin


eligible ages (years): 10.0-50.0,  All  Pneumothorax All patients requiring VATS caused by recurrent, persistent, or contralateral spontaneous pneumothorax as well as by spontaneous hemopneumothorax were eligible for this study  greater than 50 years of age, with underlying pulmonary disease, previous ipsilateral thoracic operation, allergy to tetracycline or minocycline, and unwilling to receive randomization


eligible ages (years): 18.0-999.0,  All  Critical Illness Deep Venous Thrombosis Patient is >/= 18 years of age Actual body weight is >/= 45 kg Admission to ICU expected to be >/= 72 hours in duration  Neurosurgery within last 3 months Ischemic stroke within last 3 months Intracranial hemorrhage within last 3 months Systolic Blood Pressure >/= 180mm Hg, Diastolic Blood Pressure >/= 110mm Hg for >/= 12 hours requiring vasoactive drug infusion Major hemorrhage within last week unless definitively treated Coagulopathy as defined by INR >/= 2 times upper limit of normal [ULN], or PTT >/= 2 times ULN, at time of screening Thrombocytopenia defined as platelet count </= 75 x 109/L, at time of screening Other heparin contraindications (e.g., HIT, pregnancy, lactating) Contraindication to blood products (e.g., Jehovah's Witness) Unable to perform lower limb ultrasound (e.g., bilateral above the knee amputation, or severe distal extremity burns)


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): 16.0-999.0,  All  Deep Vein Thrombosis Pulmonary Embolism Age > 16 years Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus Combined fractures of the tibia and fibula Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission  Patients presenting greater than 72 hours after injury Major injury involving other site(s) Lower extremity vascular injury requiring surgical repair Known systemic bleeding disorder or INR > 1.5, aPTT > 40 sec, or platelets < 50 x 109/L at baseline Active, uncontrolled bleeding (as determined by the attending surgeon or delegate) Intracranial or other major bleed in the previous 4 weeks Ongoing need for anticoagulation for other reasons Previous DVT or PE (objectively proven or treated with anticoagulants) Known molecular hypercoagulable state Active cancer


eligible ages (years): 0.0-999.0,  All  Quality of Health Care Pulmonary Embolism patient with suspected pulmonary embolism prescription of a specific paraclinical diagnostic investigation or start of a specific treatment for pulmonary embolism  confirmation or of pulmonary embolism before admission in emergency department confirmation of deep venous thrombosis before admission in emergency department suspicion of pulmonary embolism during hospitalization (in-patient) suspicion of pulmonary embolism without investigation realization patient already included in the study patient refusing the utilization of his data for the study


eligible ages (years): 30.0-85.0,  All  Total Hip Replacement Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower  Not able to speak dutch communication problems dementia mental retardation


eligible ages (years): 18.0-999.0,  All  Deep Vein Thrombosis (must meet 1, 2 and 3) At high risk for thromboembolism (any one of the following) Age > 35 years Obesity (> 80 kg) Para 4 Gross varicose veins Current infection Pre-eclampsia Immobility prior to surgery (> 4 days) Major current disease: includes heart or lung disease, cancer, inflammatory bowel disease, and nephrotic syndrome  (must not meet any of the following criteria) Greater than 36 hours since delivery Need for anticoagulation, including Women with a confirmed thrombophilia Women with paralysis of lower limbs Women with personal history of VTE Women with antiphospholipid antibody syndrome (APLA) Women with mechanical heart valves Contraindication to heparin therapy, including History of heparin induced thrombocytopenia


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): 18.0-999.0,  All  Pulmonary Embolism Right Heart Strain Referred from clinical departments at Odense University Hospital Referred to the Departments of Nuclear Medicine or Radiology for diagnostic evaluation of suspected pulmonary embolism Referred for lung scintigraphy, spiral computer tomography, or pulmonary angiography  Age below 18 Contrast allergy Pregnancy S-Creatinine above 200 micromol/L Metformin treatment Fibrinolytic or surgical therapy between examinations No informed consent Withdrawn consent Failed logistics (more than 24 hours between examinations) No conclusive pulmonary angiography


eligible ages (years): 40.0-999.0,  All  Embolism Hospitalization due to an acute non-surgical disease Significant decrease in mobility  Indication for anticoagulant or thrombolytic therapy Major surgical or invasive procedure within the 4 weeks that precede randomization Expected major surgical or invasive procedure (including spinal/peridural/epidural anesthesia or lumbar puncture) within the 2 weeks that follow the randomization Immobilization due to cast or fracture of lower extremity Immobilization lasting longer than 3 days in the period prior to randomization Heparin administration longer than 36 hours in the period prior to randomization Acute ischemic stroke Other protocol-defined inclusion/


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  Deep Vein Thrombosis of Lower Limb Pulmonary Embolism (PE) Bleeding Adult patient (Age >18). Patient intended to undergo elective primary unilateral THA surgery. Patient is able and willing to follow instructions of care after surgery. Patient is able and willing to sign the institution human subjects committee approved Informed Consent Form  Patient who has a known coagulation disorder. Patient currently treated with anticoagulant medications. Patient with known thrombophilia Patient with current signs and symptoms of or history of DVT/PE. Patient who is uncooperative or unable to follow instructions. Patient currently suffering from a solid tumor malignancy. Patient with active peptic disease. Patient with known allergy to baby aspirin (81 mg) or enoxaparin. Patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.Patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.Pregnant women.Patient who is participating in another clinical drug trial


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  Pulmonary Embolism Patients enrolled into the trial must meet all of the following At least 18 years of age and able to provide informed consent Objectively confirmed symptomatic APE [intraluminal filling defect on spiral computed tomography (CT) or pulmonary angiography, or high probability ventilation-perfusion (V/Q)lung scan Stable and low risk defined as Hemodynamically stable (HR≤120, no hypotension, no tachypnea, no mental status change, no shock state) O2 supplement ≤4 L/NC Lack of electrocardiographic or echocardiographic evidence for new RV strain Radiographically non-massive PE (absence of saddle emboli on PA gram or spiral CT, perfusion defect on V/Q scan <50% No significant cardiac abnormalities (EF<35%, unstable angina, positive stress test within the past 3 months without revascularization) or pulmonary disease (severe COPD, pulmonary HTN)  Patients meeting one or more of the following are not eligible for enrollment into the trial In the opinion of the clinician, the patient should receive in-patient standard medical therapy Contraindication for anticoagulation therapy (active or recent bleeding, recent surgery, bleeding diathesis, recent neurologic event) Is receiving therapeutic doses of UFH or LMWH for >24 hours Thrombolytic or glycoprotein IIb/IIIa agents administered within 24 hours prior to enrollment Platelet count <100,000 Creatinine clearance <30 mL/min at time of enrollment Presence of neuraxial anesthesia and/or post-operative indwelling epidural catheter Known history of antiphospholipid antibody syndrome Weight >150 kg (330.7 lbs) or <45 kg (99.2 lbs)


eligible ages (years): 18.0-999.0,  All  Deep Vein Thrombosis Pulmonary Embolism Symptomatic acute deep venous thrombosis and/or pulmonary embolism confirmed by venous ultrasound and/or CT scan Pulmonary embolism patients with normal right ventricular size on chest CT scan Age greater than 18 years Anticipated discharge within 72 hours of admission Written informed consent  Pregnancy or intend to become pregnant Patients requiring ongoing hospitalization > 72 hours Hypersensitivity to heparin, pork products or enoxaparin Creatinine > 2.0 mg/dl Recurrent DVT and/or PE with oral anticoagulation Surgery or medical procedure planned during the study that may pose a significant bleeding risk Prior history of heparin-induced thrombocytopenia Inability to participate for follow up appointments and study visits Life expectancy < 30 days High risk of bleeding


eligible ages (years): 18.0-999.0,  All  Deep Vein Thrombosis Pulmonary Embolism Recurrent venous thromboembolism despite anticoagulation with warfarin(Or) Clinically important bleeding complications due to warfarin(Or) Inability to achieve the target INR on warfarin(Or) Nonbleeding side effects of warfarin, such as hair loss, rash, purple toe syndrome(Or) Patient with cancer on monotherapy with parenteral anticoagulation for DVT and/ or PE and Require at least 90 days of anticoagulation Require anticoagulation for objectively confirmed DVT and/or PE Age greater than 18 years Written informed consent  Patients with renal insufficiency, defined as creatinine > 1.5 mg/dl Patients in whom anticoagulation with any agent is deemed unsafe due to bleeding risk Pregnancy Known hypersensitivity to fondaparinux


eligible ages (years): 18.0-999.0,  All  Distal (Calf) Deep-vein Thrombosis All outpatients with an acute, symptomatic, distal DVT will be included in the study, provided they correspond to the following diagnostic and   and they have signed an informed consent form Age less than 18 years Previously objectively diagnosed DVT or PE Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation) Clinically suspected pulmonary embolism Active cancer, receiving cancer treatment or cancer considered cured for <6 months Ipsilateral or contralateral proximal DVT Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...) Pregnancy Thrombocytopenia (platelet count < 100 g/l)


eligible ages (years): 18.0-999.0,  All  Pulmonary Embolism age >18 years objectively confirmed diagnosis of pulmonary embolism patients at low-risk (Pulmonary Embolism Severity Index score <=85)  patients at high-risk (Pulmonary Embolism Severity Index score >85) presence of hypoxemia (arterial SO2 <90% measured by pulse oximetry or an paO2 on room air of <60 mm Hg measured by blood gas analysis) systolic blood pressure of <100 mm Hg chest pain necessitating parenteral opioid administration active bleeding or at high-risk of major bleeding (stroke during the preceding 10 days, gastrointestinal bleeding during the preceding 14 days, or platelets <75,000 per mm3) renal failure (creatinine clearance of <30 ml/minute based on the Cockcroft-Gault formula) body mass >150 kg history of HIT or allergy to heparins therapeutic oral anticoagulation (INR ≥2)at the time of pulmonary embolism diagnosis potential barriers to treatment adherence or follow-up (alcoholism, illicit current or recent drug use, psychosis, dementia, homelessness, lack of telephone access, transportation time to nearest ED >45 minutes)


eligible ages (years): 70.0-999.0,  All  Thromboembolism Hospitalized medical patients 70 years of age or older Acute medical illness with significant decrease in mobility expected for at least 4 days (patient bedridden or only able to walk short distances) written informed consent  immobilization longer than 3 days prior to randomization prior major surgery, trauma or invasive procedure within the last 4 weeks including any injuries or operation of central nervous system expected major surgical or invasive procedure within the next 3 weeks after randomization LMWH/heparin administration longer than 48 hours in the 5 days prior to randomization immobilization due to cast or fracture indication for anticoagulatory or thrombolytic therapy acute symptomatic DVT / PE known hypersensitivity to any of the study drugs or drugs with similar chemical structures Acute or history of heparin induced thrombocytopenia type II (HIT II) Other protocol-defined inclusion/


eligible ages (years): 18.0-75.0,  All  Musculoskeletal Chest Pain Non-cardiac Chest Pain Undiagnosed Chest Pain To be included in the project the participant must Have chest pain as their primary complaint Have an acute episode of pain of less than 7 days duration before admission Consent to the standardized evaluation program at the chest pain clinic Have pain the in the thorax and/or neck Be able to read and understand Danish. Be between 18 and 75 year of age Be a resident of the Funen County Patients will not be included if any of the following conditions are present ACS Have had Percutaneous Coronary Intervention (PCI) or Coronary Artery By-pass Grafting (CABG)  Participants will be excluded following baseline evaluation if any of the following conditions are present Pain not related to the joints and muscles of the neck and/or thorax (CTA negative, see below) New incidence of any of the above mentioned conditions/pathologies


eligible ages (years): 18.0-999.0,  All  Hypertension Obesity patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus  according to SPC


eligible ages (years): 18.0-999.0,  All  Lung Cancer biopsy confirmed primary lung cancer undergoing radiotherapy or chemoradiotherapy able to perform adequate deep inspiration breath hold patients of childbearing potential must practice adequate contraception signed study-specific informed consent form  unable to perform adequate deep inspiration breath hold prior tumor resection prior chest or neck RT pregnant


eligible ages (years): 18.0-65.0,  All  Cervical Degenerative Disc Disease Male or female subjects, aged between 18 and 65 years inclusive Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained Subjects who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups Objective evidence of cervical disc disease in one vertebral level between C3-C7 defined as one or more of the following Shoulder and/or arm pain in a radicular distribution resulting from herniated disc or bony osteophytes (Consistent w diagnostic imaging including Axial CT, CT Myelogram, MRI and/or plain films) Subjects with myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement Unresponsive to documented non-surgical management for ≥ 6 weeks and/or presents with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management (e.g., physical therapy, medication therapy, corticosteroid injections, etc.) Minimum Neck Disability Index score of ≥30 % (15/50 points)  Subjects who, in the opinion of the Clinical Investigator, have an existing condition that would compromise their participation and follow-up in this clinical investigation Subjects who are pregnant, lactating or wishes to become pregnant within the duration of the study Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes Subjects who have participated in a clinical investigation with an investigational product in the last 30 days Subjects who are currently involved in any injury litigation claims Subjects with significant degeneration at more than one cervical level (e.g. DISH, ankylosing spondylitis, congenital abnormality, rheumatoid arthritis) Subjects who have had any prior surgery at the level to be treated (subjects with a prior Laminotomy at the level to be treated may be included in the study) Subjects who have marked cervical instability on lateral or flexion/extension x-rays defined as translation ≥3mm and/or ≥11 degrees of rotational difference to either adjacent level Subjects who have presence of systemic infection or infection at the site of surgery Subjects who have been diagnosed with malignancy


eligible ages (years): 18.0-999.0,  All  Chronic Obstructive Pulmonary Disease Asthma Pulmonary Embolism Pneumonia Pulmonary Hypertension Presenting to the Emergency Department with signs and symptoms of dyspnea (short of breath, tachypnea, hyperventilation, etc) within the last 24 hours Normal cardiac output as measured by noninvasive bioimpedance Greater than or equal to 18 years of age Patient or legal representative willing and able to provide informed consent and comply with study procedures  A history of congestive heart failure and a BNP > 500pg/mL (or NTproBNP > 900pg/mL) if obtained by the treating physician Treating physician suspects patient has new onset congestive heart failure ECG changes diagnostic of acute myocardial ischemia/infarction Ischemic chest pain within the prior 24 hours by history Obvious chest trauma


eligible ages (years): 18.0-75.0,  All  Deep Vein Thrombosis Pulmonary Embolism Be >= 18 years of age Have had ONE episode of unprovoked proximal DVT and/or PE Have completed 3 uninterrupted months of warfarin therapy (target INR of 2.0-3.0)  Another indication for long-term anticoagulation (e.g., atrial fibrillation) A high risk of bleeding as evidenced by any of the following Age greater than 75 years Previous episode of major bleeding where the cause was not effectively treated Known chronic thrombocytopenia with a platelet count of less than 120,000 x 10^9 /L Known chronic renal impairment with a creatinine of more than 150 mumols /litre (1.7 mg/dl) Known chronic liver disease with a total bilirubin of more than 25 mumols /litre (1.5 mg/dl) Active peptic ulcer disease Poor compliance with, or control of, anticoagulant therapy during initial treatment Requires dual antiplatelet therapy (e.g. aspirin and clopidogrel)


eligible ages (years): 18.0-999.0,  All  Pulmonary Embolism Patients with a first episode of idiopathic pulmonary embolism who have been treated during 6 months (Plus 30 days or minus 15 days) using Vitamin K antagonist with a INR between 2 and 3  Age < 18 warfarin hypersensibility unwilling or unable to give written informed consent distal or proximal deep vein thrombosis Pulmonary embolism which was provoked by a reversible major risk factor major thrombophilia (protein C, S or antithrombin deficiency, antiphospholipids antibodies, homozygous factor V Leiden) previous documented episode of proximal deep vein thrombosis or pulmonary embolism other indication for anticoagulant therapy (e.g.:atrial fibrillation, mechanic valve) patient on antithrombotic agent in whom antithrombotic agent should be started again after stopping anticoagulation pregnancy