A 65-year-old male with a history of tuberculosis has started to complain of productive cough with tinges of blood. Chest X-ray reveals a round opaque mass within a cavity in his left upper lobe. The spherical mass moved in the cavity during supine and prone CT imaging. Culture of the sputum revealed an organism with septated, low-angle branching hyphae that had straight, parallel walls.

eligible ages (years): 0.0-999.0,  All  Acquired Immunodeficiency Syndrome Aspergillosis HIV Infections Immunologic Deficiency Syndromes Neutropenia Males and females of greater than 12 years of age with any of the following conditions Allogeneic or autologous bone marrow/ peripheral stem cell transplant Hematological malignancy (including lymphoma) Aplastic anemia and myelodysplastic syndromes (currently on immunosuppressive treatment) Solid organ transplantation Solid organ malignancy (after cytotoxic chemotherapy) HIV infection/AIDS High dose prolonged corticosteroid therapy (greater than or equal to 20 mg daily of prednisone or equivalent for greater than 3 weeks) or prolonged therapy with other immunosuppressive agents (e.g., azathioprine, methotrexate) WITH a diagnosis of definite or probable acute invasive aspergillosis The fungal infection at baseline should represent a new episode of acute invasive aspergillosis. Any course of systemic treatment with amphotericin B (conventional or lipid formulation) or itraconazole should have been completed at least 8 weeks prior to study entry


eligible ages (years): 2.0-999.0,  All  Tuberculosis Males or nonpregnant, non-nursing females > 2 years old Tuberculin (PPD) skin test reactors at high risk for developing TB but without evidence of active TB. High-risk reactors are defined as Household and other close contacts of persons with culture-confirmed TB who are TST-positive as part of a contact investigation conducted within two years of the date of enrollment. Close contact is defined as > 4 hours in a shared airspace during a one-week period. Among close contacts, a positive TST is defined as > 5 mm induration after 5 TU of PPD placed intradermally using the Mantoux technique TST converters--converting from a documented negative to positive TST within a two-year period. This is defined as persons with a tuberculin skin test of > 10 mm within two years of a nonreactive test or persons with an increase of > 10 mm within a two-year period HIV-seropositive, TST positive (> 5 mm induration) persons Persons with > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray, no prior history of TB treatment, > 5 mm induration on TST, and 3 sputum cultures negative for M. tuberculosis on final report HIV-seropositive close contacts of persons with culture-confirmed TB, regardless of TST status. In addition, HIV-seropositive close contacts of persons with culture-confirmed TB who have a documented history of completing an adequate course of treatment for active TB or latent TB infection, are also eligible Willing to provide signed informed consent, or parental consent and participant assent  Current confirmed culture-positive or clinical TB Suspected TB (as defined by the site investigator) Tuberculosis resistant to isoniazid or rifampin in the source case A history of treatment for > 14 consecutive days with a rifamycin or > 30 consecutive days with INH during the previous 2 years A documented history of a completing an adequate course of treatment for active TB or latent TB infection in a person who is HIV-seronegative History of sensitivity/intolerance to isoniazid or rifamycins Serum aminotransferase aspartate (AST, SGOT) > 5x upper limit of normal among persons in whom AST is determined Pregnant or nursing females Persons currently receiving or planning to receive HIV-1 protease inhibitors or nonnucleoside reverse transcriptase inhibitors in the first 90 days after enrollment Weight < 10.0 kg


eligible ages (years): 2.0-999.0,  All  Infection Unspecified Adult Solid Tumor, Protocol Specific Proven or probable invasive aspergillosis or other filamentous fungal infection by cytology, histopathology, or culture within the past 7 days Presenting with 1 of the following Cancer Aplastic anemia Inherited immunodeficiencies Autoimmune deficiency disorders Acquired immunodeficiencies Recipient of autologous peripheral blood stem cell or bone marrow transplantation CNS aspergillosis or other filamentous fungal infection allowed No invasive zygomycosis infection


eligible ages (years): 0.083-999.0,  All  Invasive Aspergillosis Other Fungal Infections Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, hematopoietic stem cell transplantation, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (greater than or less than 20 mg of Prednisone or equivalent for greater than or less than 3 weeks), treatment with other immunosuppressant medications, or other acquired or hereditary immunocompromising conditions that place the patients at risk for IFI. Evidence of Proven, Probably or Possible IFFI by modified EORTC criteria. Continued treatment with study drug is contingent upon confirmation of diagnosis of Proven or Probable IFI within 4 working days after study entry  Life expectancy of less than 30 days; chronic IFI (defined as signs/symptoms of IFI present for less 4 weeks preceding entry into study;prior systemic therapy of greater than or less than 4 days with any polyene anti-fungal agent within 14 days of study enrollment;prior systemic therapy of greater than or less than 4 days with non-polyenes for the current, documented IFI. Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug; serum creatinine greater than 2 x upper limit of normal (ULN), serum ALT or AST less than 5 x ULN; pregnant or lactating women; history of allergy or serious adverse reaction to any polyene anti-fungal agent


eligible ages (years): 18.0-80.0,  All  Invasive Aspergillosis Patients fulfilling all the following will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent  Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study


eligible ages (years): 18.0-75.0,  All  Arthritis, Rheumatoid Diagnosis of RA according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed at least 6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and 2 of the following morning stiffness >=45 min ESR >=28 mm/h CRP >=20 mg/L Men and women, >=18 to <=75 years of age Men and women of childbearing potential must be using adequate birth control measures (abstinence, oral contraceptives, IUD, barrier method with spermicide or, surgical sterilization) and should continue such precautions for 6 months after receiving the last infusion Patients must have been using oral or parenteral MTX for at least 3 months with no break(s) in treatment of more than 2 weeks total during this period. Patients must have been on a stable dose of >=12.5 mg/wk (maximum 20mg/wk) for at least 4 weeks prior to screening  Pregnant women, nursing mothers or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from the Infliximab therapy, eg Lyme disease, or a rheumatic disease other than RA Use of DMARDs other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months Prior use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents Have a history of any clinically significant adverse reaction to murine or chimeric proteins, including but not limited to allergic reactions


eligible ages (years): 18.0-75.0,  All  Psoriasis Adult male and female subjects (>= 18 to 75 years of age) with a diagnosis of moderate to severe plaque-type psoriasis for at least 6 months prior to study screening (subjects with concurrent psoriatic arthritis may also be enrolled) Subjects must be eligible for phototherapy or systemic therapy for their psoriasis and must have a Baseline Psoriasis Area and Severity Index (PASI) score of 12 or greater and have at least 10% of their total body surface area (BSA) involved at Baseline Subjects must agree to avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study Subjects must also meet the tuberculosis (TB) assessment and screening as follows: Have no history of latent or active TB prior to screening; have no signs or symptoms suggestive of active TB upon medical history and/or physical examination; have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study medication; within 1 month prior to the first administration of study medication, either have negative diagnostic TB test results (defined as 2 negative tuberculin skin tests) OR have a newly identified positive diagnostic TB test result (defined as at least 1 positive tuberculin skin tests) during screening in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study medication Subjects must have had a chest x-ray (posterior-anterior and lateral) within 3 months prior to Screening with no evidence of malignancy, infection, fibrosis, or current or old active TB Specific parameters must also be met with regard to screening laboratory test results and liver enzymes in order to be eligible to participate in the study  Subjects who have non-plaque forms of psoriasis, current drug-induced psoriasis, are pregnant, nursing, or planning pregnancy Subjects previously treated with MTX or infliximab; subjects who are taking specific drugs within the specified time frame prior to Baseline as follows: any therapeutic agent targeted at reducing tumor necrosis factor (TNF) or any biologic, live virus or bacterial vaccinations within 3 months; any systemic medications or treatments that could affect psoriasis or PASI evaluations, or any systemic immunosuppressants or lithium within 4 weeks; any topical medications or treatments that could affect psoriasis or PASI evaluations within 2 weeks. The only allowed topical treatments for psoriasis are shampoos (containing tar or salicylic acid only) and topical moisturizers. Subjects should not use these topical agents during the morning prior to a study visit. Non-medicated shampoos may be used on the morning of a visit Subjects with poor health, including concomitant congestive heart failure (CHF); history of chronic or recurrent infectious disease, as specified; human immunodeficiency virus, hepatitis B, or hepatitis C; demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis; systemic lupus erythematosus; or who have had serious infections (eg, hepatitis, pneumonia, or pyelonephritis], or who have been hospitalized or received IV antibiotics, or who had an opportunistic infection (eg, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB), or a transplanted organ within specified time frames; or other conditions as specified in the protocol Subjects who have used any investigational drugs within 4 weeks of Screening, who are participating in other clinical studies, staff or family members of study staff are excluded from participation in the study


eligible ages (years): 18.0-999.0,  All  Aspergillosis Male or female hospitalized patients aged > 18 yr The patient has a hematologic malignancy or will receive a bone-marrow transplant The patient starts with a course of chemotherapy within 4 days or is already neutropenic at admission The expected duration of severe neutropenia (PMN<0.5x10*9/L) following study entry is > 10 days The patient is receiving oral antibiotic prophylaxis and fluconazole Written informed consent has been obtained  The patient shows evidence of a pulmonary fungal infection or a fungal sinusitis at trial entry The concomitant use of systemic anti-aspergillus treatment such as itraconazole or any intravenous formulation of amphotericin B at study entry Known hypersensitivity to amphotericin B Any evidence of pneumonia or pneumonitis at trial entry Any impossibility to use a nebulizer properly Expected survival < 3 months at entry Pregnancy


eligible ages (years): 18.0-85.0,  All  Non-small Cell Lung Cancer Histologic confirmation of non-small cell lung cancer, mesothelioma or a radiographic lesion highly suspicious for malignancy Written informed consent Must be scheduled for a biopsy or surgical resection  Subjects with any "other" prior cancer (other than lung) within 5 years of date of surgery are NOT eligible (unless there is preoperative pathologic confirmation that the lung mass is a second primary cancer) Subjects with any type of lung cancer other than non-small cell lung cancer(NSCLC)


eligible ages (years): 10.0-999.0,  All  Invasive Aspergillosis Adults and children > 10 years old The patient is able to understand and has signed a written informed consent OR the parent or legal guardian is able to understand and has signed a written informed consent, which must be obtain prior to the initiation of any study procedures Immunocompromised due to hematologic malignancies, chemotherapy-induced neutropenia, solid organ transplantation, other conditions resulting in severe neutropenia, HIV infection, prolonged corticosteroid therapy (≥ 20 mg Prednisone or equivalent for ≥ 3 weeks) or treatment with other immunosuppressant medications Evidence of Proven or Probable Invasive Aspergillosis, by modified EORTC (Appendix 2), as modified below: • Proven Invasive Aspergillosis • Histopathologic or cytopathologic examination showing hyphae consistent with the presence of aspergillus from needle aspiration or biopsy specimen with evidence of associated tissue damage (either microscopically or unequivocally by imaging); or • Positive culture result for aspergillosis from a sample obtained by sterile procedure from normally sterile and clinically or radiologically abnormal site consistent with infection, excluding urine and mucous membranes • Probable Invasive Aspergillosis • At least 1 host factor criterion; and • 1 microbiological criterion; and major (or 2 minor) clinical from abnormal site consistent with infection; and • No other pathogens detected to account for the clinical or radiographic signs of infection Or (Modification of EORTC Criteria): • Patients with recent Neutropenia (absolute neutrophil count < 500 cells/mm3 within 14 days of study enrollment); and • Chest CT scan positive for "Halo" or "Air Crescent" Sign (see Section 4.2.1, Diagnostic Considerations, below) and • No other pathogens detected to account for the clinical or radiographic signs of infection Females of childbearing potential must be surgically incapable of pregnancy, or practicing an acceptable method of birth control with a negative pregnancy test (blood or urine) at baseline  Life expectancy < 30 days Allogenic stem cell transplant in the 6 previous months Chronic invasive fungal infection, defined as signs/symptoms of invasive fungal infection present for > 4 weeks preceding entry into study Prior anti-fungal systemic therapy of ≥ 96 hours for the current, documented IA. (On the other hand, is permissible prior systemic anti-fungal therapy for prophylaxis or as empiric therapy for febrile neutropenia) Use of another investigational, unlicensed drug within 30 days of screening or concurrent participation in another clinical trial using an investigational, unlicensed drug • Serum creatinine > 2x upper limit of normal (ULN) Serum ALT or AST > 5 x ULN Pregnant or lactating women History of allergy or serious adverse reaction to any polyene anti-fungal agent or echinochandin derivatives


eligible ages (years): 12.0-999.0,  All  Aspergillosis Patients with newly diagnosed acute leukemia or high risk myelodysplastic syndrome (MDS) receiving induction chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with relapsed acute leukemia or MDS receiving salvage chemotherapy with expected duration of neutropenia (absolute neutrophil count of < 500/mL) of at least 10 days Patients with severe aplastic anemia (SAA) receiving chemotherapy or immunosuppressive therapy using antithymocyte globulin Patients receiving allogeneic/autologous hematopoeitic stem cell transplant (HSCT) using myeloablative conditioning regimens Patients are at least 12 years of age, with Karnofsky score of 70%.? Patients on consolidation chemo regimens like HIDAC and HyperCVAD type B with expected duration of neutropenia (ANC < 500/ml) of at least 10 days  Patients who are human immunodeficiency virus (HIV) infected Patients with uncontrolled bacteremia or active pulmonary infection at the time of randomisation Patients with pre-existing proven and probable invasive fungal infections, according to the definitions of the invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Disease [10] Patients receiving concomitant piperacillin/tazobactam or co-amoxyclavulinic acid Patients on palliative chemotherapy Patients with history of allergy to triazoles Patients with prior history of anaphylactic reaction to conventional amphotericin B Patients with serum levels of aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, or bilirubin more than 5 times the upper limit of normal or renal impairment with calculated creatinine clearance < 30ml/min Patients with expected life-expectancy < 72 hours


eligible ages (years): 18.0-999.0,  All  Acute Myeloid Leukemia Allogeneic Haematopoietic Progenitor Cell Transplant Patient has decided voluntary to consent his or her participation signing the consent form before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care Patients with Acute myeloid Leukemia (AML), that will start induction chemotherapy or those patients submitted to an Allogeneic haematopoietic progenitor cell transplant The patient is >18 years old  Patient with prior Invasive Pulmonary Aspergillosis (IPA) history History of allergy or hypersensitivity to Amphotericin B Patient with intellectual deficit or patients with psychological alterations that make impossible the trial understanding Pregnancy or breastfeeding Patient has received other investigational drug or non traded product within 30 days before trial beginning Patient is enrolled in another clinical research study or/and is receiving an investigational agent for any reason Patient had major surgery within 4 weeks before enrollment


eligible ages (years): 19.0-65.0,  All  Rheumatoid Arthritis Patients aged >35 and <=65 years with a diagnosis of rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) for at least 1 year and no more than 10 years prior to start of therapy; have active disease (Disease Activity Score [DAS] 28 >2.8 and <3.5), with changes in the DAS 28 score <0.6 within the 6 weeks before inclusion; have stable RA basic therapy according to standard for at least 3 months; have a chest X-ray within 1 month prior to first infusion with no evidence of malignancy, infections, or fibrosis; and have screening laboratory test results that meet prespecified criteria. Patient must have at least one swollen joint. Patient must have evidence of erosive disease by x-ray at baseline  Patients were excluded if they met any of the following Women who are pregnant, nursing, or planning pregnancy within 15 months after screening (i.e., approximately 6 months following last infusion) Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer History of any other therapeutic agent targeted at reducing tumor necrosis factor (TNF) History of previous administration of infliximab History of receiving human/murine recombinant products or has a known allergy to murine products Serious infection (such as hepatitis, pneumonia or pyelonephritis) in the previous 3 months. Less serious infections (such as acute upper respiratory tract infection [colds] or simple urinary tract infection) need not be considered exclusions at the discretion of the investigator Active tuberculosis (TB) or evidence of latent TB (positive purified protein derivative [PPD] skin test, a history of old or latent TB or chest X-ray without adequate therapy for TB initiated prior to first infusion of study drug), or evidence of an old or latent TB infection without documented adequate therapy. Patients with a current close contact with an individual with active TB and patients who have completed treatment for active TB within the previous 2 years are explicitly excluded from the trial. Patients with a household member who has a history of active pulmonary TB should have had a thorough evaluation for TB prior to study enrollment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies Hepatitis B surface antigen or Hepatitis C (HCV) antibody positive; documented Human Immunodeficiency Virus (HIV) infection Have an opportunistic infection, including but not limited to evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterium infection, etc, within the previous 6 months


eligible ages (years): 6.0-999.0,  All  Cystic Fibrosis Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride greater than 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations Patient must be known to be chronically colonized with Aspergillus fumigatus Patients must be clinically stable at randomization, no use of new inhaled, oral or intravenous antibiotics or oral or intravenous corticosteroids during the 14-day period prior to randomization Patients must weigh at least 20 kg Post-menarche females must be using an effective form of contraception  Inability to give informed consent Respiratory culture positive for B.cepacia complex Renal function abnormalities-Creatinine greater than 1.5 times upper limit of normal within a 30 day period prior to randomization Liver function abnormalities : AST or ALT greater or equal to 2.5 times the upper limit of normal within a 30 day period prior to randomization Neutropenia, absolute neutrophil count< or = 1000 within a 3-day period prior to randomization History of biliary cirrhosis documented by liver biopsy or imaging History of portal hypertension Investigational drug use within 30 days of randomization date History of alcohol, illicit drug or medication abuse within 1 year of randomization Women who are pregnant, breastfeeding or trying to conceive


eligible ages (years): 18.0-75.0,  All  Arthritis, Rheumatoid Patients received placebo in main double-blind study (P04280, NCT00202852) Patients received Infliximab-containing regimen showing clinical response at week 30 in main double-blind study (P04280) [Main double-blind study (P04280, NCT00202852) criteria] Diagnosis of rheumatoid arthritis (RA) according to the revised 1987 of the American Rheumatism Association (Arnett et al, 1988). The disease should have been diagnosed >6 months prior to screening Active disease at the time of screening and pre-infusion as defined by >=6 swollen joints >=6 tender joints and of the following morning stiffness >=45 min erythrocyte sedimentation rate (ESR) >=28 mm/h  below of main double-blind study (P04280, NCT00202852) [Main double-blind study (P04280, NCT00202852) Pregnant women, nursing mothers, or a planned pregnancy within 1.5 years of enrollment Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care Patients who have any current systemic inflammatory condition with signs and symptoms that might confound the evaluations of benefit from infliximab, eg Lyme disease, or a rheumatic disease other than RA Use of disease modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to screening. (If a patient had prior exposure to leflunomide within the past 6 months, cholestyramine 8 g should be given 3 times daily for 11 days to rapidly lower the plasma level of leflunomide.) Use of intra-articular, i.m. or i.v. corticosteroids (including i.m. ACTH) within 4 weeks prior to screening Have been previously treated with infliximab or genetic recombinant therapy with RA (e.g. etanercept, adalimumab) Treatment with any other therapeutic agent targeted at reducing TNF (eg, pentoxifylline or thalidomide) within the previous 3 months Treatment with any investigational drug within the previous 3 months


eligible ages (years): 18.0-999.0,  All  Hidradenitis Suppurativa Subjects with moderate to severe HS as defined by a HSSI > 8 AND at least ONE of the following HS >1 year duration with multiple ER or doctors visits related to HS Intralesional kenalog injection >5/year, however none within 2 weeks of entry Failed systemic retinoids, but not within 3 months of entry Failed at least one prior course of antibiotic therapy, which must not have been administered within 2 weeks of entry to the study (excluding the recommended antibiotic regimen given for evidence of active infection immediately before enrollment) History of surgery (reconstructive), but not within 3 months of entry  Women who are pregnant, nursing, or planning pregnancy within 6 months after the last injection (this includes father's who plan on fathering a child within 6 months after their last injection) Use of other systemic anti-inflammatory medication except NSAIDs and low dose systemic steroids (equal or less than 10 mg daily prednisolone or equivalent) If found to have an active infection, patients must have completed topical or oral antibiotic therapy at least 7 days before first injection Have a known history of serious infections (e.g., hepatitis, pneumonia or pyelonephritis) in the previous 3 months Have or have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening Have a history of lymphoproliferative disease, including lymphoma or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infraclavicular, epitrochlear, or periaortic area), or splenomegaly Have a concomitant diagnosis or history of congestive heart failure Have a history of latent or active granulomatous infection, including TB, histoplasmosis, or coccidioidomycosis, prior to screening


eligible ages (years): 16.0-999.0,  All  Hematological Diseases Invasive Aspergillosis Age > 16 years Allogeneic HSCT for a haematological disease Written informed consent to the study  Pediatric patients


eligible ages (years): 18.0-999.0,  All  Lung Cancer Diagnosis of non-small cell lung cancer Stage I-IIIB disease No prior surgical tumor resection Respiration-induced tumor motion > 5 mm Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals Not pregnant No insufficient lung function or other parameters prohibiting a bronchoscopy Not a prisoner or institutionalized See Disease Characteristics Concurrent chemotherapy allowed


eligible ages (years): 4.0-45.0,  All  Cystic Fibrosis, informed consent age between 4 and 45 years well-known Cystic fibrosis Lung function: FEV1 (% pred.) ≥ 70%  age < 4 and > 45 years lung function: FEV1 (% pred.)< 70% other chronic diseases or infections (e.g., HIV, tuberculosis, malignancy) pregnancy known alcohol, drug and/or drug abuse inability to capture the scale and scope of the study participation in another study


eligible ages (years): 1.0-999.0,  All  Immunocompromised Host Invasive Pulmonary Fungal Infection Invasive Pulmonary Aspergillosis Invasive Pulmonary Zygomycosis Patients currently enrolled in any NIH IRB approved Clinical Center protocol or under treatment at the CNMC who are undergoing bronchoscopy or lung biopsy for diagnosis of possible invasive pulmonary aspergillosis or invasive pulmonary zygomycosis Informed consent of the patient or the patient's legally authorized representative Fulfillment of one or more of the following EORTC/MSG host History of neutropenia (ANC < 500/mm(3)) within the past 3 months temporally related to the onset of radiographic changes Receipt of an allogeneic HSCT Receipt of solid organ transplantation Prolonged use of corticosteroids at an average minimum dose of 0.3 mg/kg/day prednisone equivalent for > 3 weeks Treatment with other recognized T-cell immune suppressants such as cyclosporine, TNF alpha blockers, specific monoclonal antibodies such as alemtuzumab, nucleoside analogues during the past 90 days Myelodysplastic syndrome Severe aplastic anemia  Interstitial or diffuse infiltrates on chest CT or radiograph Inability to provide informed consent Children weighing less than 10 kg Any other concomitant condition, which in the opinion of the investigator would place the patient at risk by participating in the study


eligible ages (years): 18.0-999.0,  All  HIV Infection Pulmonary TB Age above 18 years HIV-1/2 infected patients with Pulmonary TB. This includes sputum smear positive disease Initially smear negative but (Becton-Dickinson) culture positive (e.g. miliary TB, Mediastinal adenitis and Chest x-ray with persistent abnormality after antibiotics) Persistent X-ray abnormality will be included for allocation. However final into both ITT and efficacy analysis will depend on positivity in LJ culture Living within 40 km radius from the nearest sub centre of TRC and willing for attendance as prescribed Likely to remain in the same area for at least one and half years after start of treatment Willing for house visits and surprise checks Willing to participate and give informed consent after going through the terms and conditions of the trial  Patients with known hypersensitivity to rifampicin Pregnancy and lactation at initial presentation Major complications like HIV encephalopathy, renal dysfunction (serum creatinine > 1.5 mg% in the absence of dehydration) or jaundice (serum bilirubin > 2 mgs% along with SGOT /SGPT elevation > 2.5 times the upper limit of normal) Previous anti-tuberculosis treatment for more than 1 month. Prophylaxis (non-rifampicin containing regimen) will not be considered as prior antituberculosis treatment Moribund, bedridden or unconscious patients Co-morbid conditions like uncontrolled diabetes mellitus, cardiac failure, and malignancy at initial presentation Major psychiatric illness Patients on second line ART, mainly protease inhibitors, at initial presentation


eligible ages (years): 0.0-999.0,  All  Allergic Bronchopulmonary Aspergillosis Diagnosis of ABPA Presence of all the following three immediate cutaneous hyperreactivity on aspergillus skin test elevated total IgE levels > 1000 IU/mL A fumigatus specific IgE levels > 0.35 kU/L, AND Presence of two of the following presence of serum precipitating antibodies against A fumigatus fixed or transient radiographic pulmonary opacities absolute eosinophil count > 1000/µL central bronchiectasis on HRCT  If they have taken glucocorticoids for more than three weeks in the preceding six months Failure to give informed consent Enrollment in another trial of ABPA


eligible ages (years): 18.0-65.0,  All  Liver Transplantation Aspergillus Interleukin-17 Treg Cell Immune Tolerance Liver transplantation patients  Psychopath


eligible ages (years): 0.0-999.0,  All  Invasive Aspergillosis BAL in hematological neutropenic patients at high risk of IA, admitted to our hospital, in which we usually perform a BAL for microbiological study when they present persistent fever and an opportunist infection suspicion BAL in patients without hematological illness and without IA suspicion, in which we perform an BAL because of another reason  Patients without fulfilling criteria Patients with some contraindication to perform a bronchoscopy


eligible ages (years): 35.0-85.0,  All  Osteoarthritis, Knee Adults ≥ age 35 but ≤ age 85 Painful knees for 3-60 months VAS joint pain score greater than 30 mm (scale 0-100) Knee radiograph showing minimal to moderate change (early OA) No NSAID therapy for at least one week Have the capacity to understand and sign an informed consent form Gender: Male or female Women must be postmenopausal (no menstrual period for a minimum of 1 year) or surgically sterilized and have a negative serum pregnancy test on entry in the study. Men must agree to use adequate birth control during the study for 6 months after the infusion of study agent Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization) for the duration of the study and should continue such precautions for 6 months after receiving the last infusion The screening laboratory test results must meet the following  Moderate to Severe OA, as determined by severe joint space narrowing (Kellgren grade IV) (7) in medial and lateral compartments Insulin-dependent diabetes mellitus Systemic inflammatory illness, e.g. rheumatoid arthritis Intra-articular injections within 3 months Prior treatment with infliximab or other anti-TNF drug Acute injury to knees (< 2 weeks) Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion) Have had any previous treatment with monoclonal antibodies or antibody fragments History of receiving human/murine recombinant products or a known allergy to murine products. A known allergy to murine product is definitely an criterion Documentation of a positive test for hepatitis B surface antigen or hepatitis C


eligible ages (years): 18.0-90.0,  All  Invasive Aspergillosis proven or probable invasive aspergillosis with positive GM antigen test  Seronegative aspergillosis


eligible ages (years): 16.0-999.0,  All  Hematologic Disease Solid Organ Transplantation IPA cases with solid organ transplant recipients and hematologic disease patients proven and probable invasive pulmonary aspergillosis by modified EORTC/MSG  under 16 years old possible cases of invasive pulmonary aspergillosis


eligible ages (years): 18.0-999.0,  All  Aspergillosis The patient or legally authorized representative has signed an informed consent/assent Assent will be obtained as required by the UAMS IRB The patient has a diagnosis of proven or probable invasive aspergillosis and with positive Aspergillus GM index (≥0.5 ng/ml) provide the patient is not receiving antibiotics, such as piperacillin-tazobactam, that are known to cause false positive GMI The patient is 18 years of age or older  The patient is being treated with an unlicensed investigational drug for aspergillosis The patient has been administered an antifungal agent (voriconazole, itraconazole, posaconazole, caspofungin, micafungin, anidulafungin, amphotericin B, or lipid formulation of amphotericin B) for > 7 days immediately prior to randomization for treatment of the Probable, or Proven invasive aspergillosis for which the patient is being enrolled Patient has invasive aspergillosis but with negative Aspergillus GM index The patient is pregnant or lactating. If the patient is female and of childbearing potential, the patient must have a negative pregnancy test and avoid becoming pregnant while receiving study drug. A pregnancy test should be performed within 14 days prior to the first dose of study drug The patient has alkaline phosphatase, ALT, AST or total bilirubin greater than five times the upper limit of normal The patient has hepatic cirrhosis Patients with creatinine > 3 will be enrolled only if able to receive oral voriconazole (specify oral loading dose is 6 mg/kg PO Q 12 hours for 24 hours) then oral maintenance 200 mg PO q 12 hours) The patient is on artificial ventilation, and unlikely to be extubated within 24 hours of study entry The patient has a history of allergy, hypersensitivity, or any serious reaction to the azole or echinocandin class of antifungal agents The patient has previously enrolled into this study


eligible ages (years): 16.0-999.0,  All  Cystic Fibrosis Allergic Bronchopulmonary Aspergillosis A. Fumigatus Male or female ≥ 12 years of age at enrollment Confirmed diagnosis of CF based on the following One or more clinical features consistent with the CF phenotype AND (b or c) Positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) two identifiable mutations consistent with CF Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study Clinically stable at enrollment as assessed by the site investigator Past or present respiratory culture positive for Aspergillus fumigatus IgE ≥ 250 and/or presence of class II or higher aspergillus specific IgE on enrollment Ability to comply with medication use, study visits and study procedures as judged by the site investigator -  Systemic corticosteroids (1 mg/kg if < 20 kg or > 20 mg of prednisone per day) Investigational drug use within 30 days of screening 3. Laboratory abnormalities at screening a. Serum Calcium > 11 mg/dl b. 25(OH) D > 50 ng/ml at screening. c. Creatinine ≥ 1.5, or estimated GFR <60 by Cockcroft-Gault or MDRD equation. d. LFT≥ 3xULN History of transplantation or currently on lung transplant list 5. Positive serum pregnancy test at screening (to be performed on all post-menarche females) 6. Pregnant, breastfeeding, or if post-menarche female, unwilling to practice birth control during participation in the study 7. Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data 8. Diagnosis of HIV and a CD4+ T cell count below 500 cells/ml or active hepatitis B or C infection Undergoing therapy for non-tuberculous mycobacterial infection


eligible ages (years): 16.0-999.0,  All  Invasive Pulmonary Aspergillosis hospitalisation in the hematology or intensive care department age > 16 years informed consent proven or probable IPA (EORTC/ MSG criteria) galactomannan positivity in BAL or serum  age < 16 years


eligible ages (years): 18.0-999.0,  All  Lung Transplant Recipient Single or double lung transplant recipients who are at least one year out of transplantation Age >18yrs of age Able to understand and complete informed consent  Pregnant woman or woman capable of bearing children, who will not perform urine pregnancy test Nursing mothers Subjects with hypersensitivity to Amphotericin deoxycholate or liposomal Amphotericin Subjects with a past history of bronchospasm associated with aerosol drug use Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications Subjects treated with cytolytic medications (Campath /Thymoglobulin) within the last month Subjects with an FEV1< 30% Predicted or FVC% <30% Subjects requiring supplemental oxygen Receipt of Inhaled or IV Amphotericin B within last 30 days Subjects with known fungal infection as per MSG on therapy with antifungal drugs or diagnosed on the day of bronchoscopy


eligible ages (years): 14.0-80.0,  All  Chronic Cavitary Pulmonary Aspergillosis Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks Radiological findings Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species The diagnosis of CCPA will be made if Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria FNAC from the cavity wall will be considered in atypical cases  Invasive aspergillosis Allergic broncho-pulmonary aspergillosis (ABPA) Active tuberculosis or malignancy Pregnant females


eligible ages (years): 18.0-999.0,  All  Infection The for participants to enter the study mandates that each patient have received a standard (current clinical practice) diagnostic evaluation that includes a CT scan of the chest to document bronchiectasis, prior to enrolling in the Consortium study. To enter this protocol, adults must have bronchiectasis and meet the following Males or females, age greater than or equal to18 years Chronic cough An available CT of the chest (on a CD) that shows evidence of dilated airways fulfilling radiographic for bronchiectasis in more than one lobe Ability to provide informed consent, including HIPAA consent  A participant should not be in the study if they have not had a standard clinical evaluation to rule out other potential causes of chronic sino-pulmonary disease Known diagnosis of cystic fibrosis with classic clinical presentation and elevated sweat chloride levels and/or two known disease-causing CFTR mutations History of tuberculosis or other known explanation for bronchiectasis, such as alpha 1-antitrypsin deficiency (ZZ or ZS), confirmed or probable PCD, inflammatory bowel disease, rheumatoid arthritis, Sjogren s syndrome, allergic bronchopulmonary aspergillosis, or documented primary or acquired immunodeficiency Current smoker or > 10 pack-year history of tobacco use Prior solid organ transplant


eligible ages (years): 0.083-14.0,  All  Tuberculosis Any child with at least one of the following Unexplained weight loss or documented failure to thrive or stagnant weight or Growth faltering on the growth charts over the past 3 months despite adequate nutrition and deworming Non remittent cough or wheeze for more than 2 weeks Night sweats persistent or intermittent during the last 2 weeks Prolonged fever (temperature > 38°C) for 7 days, after common causes such malaria or pneumonia has been excluded Wheeze/Stridor persistent, non remitting during the last 2 weeks Chest pain Persistent, localized, pleuritic in nature during the last 2 weeks  Current TB treatment (patient who received < 3 days of treatment or patients receiving IPT could be still included) or TB treatment completed within the past 6 months Absence of informed consent Living outside of Greater Mbarara region Unable or unwilling to attend to the follow-up visits


eligible ages (years): 5.0-80.0,  All  Invasive Aspergillosis hematological patients with lung infiltrates at high risk for invasive aspergillosis  patients without informed consent


eligible ages (years): 5.0-85.0,  All  Invasive Aspergillosis immunocomprimised patients with high risk of invasive aspergillosis and lung infiltrates informed consent  Children under the age of 5 years Informed consent not available


eligible ages (years): 18.0-80.0,  All  Ventilator Associated Pneumonia All adult patients above 18 years old admitted into the Intensive Care unit and who is to be intubated and likely to receive more than 72 hours of ventilation would be admitted into the trial  presence of cavitary lung disease based on chest x-ray findings primary lung cancer or another metastatic malignancy to the lungs, or known or suspected viral or fungal etiology pneumocystis carinii pneumonia legionella OR Mycoplasma pneumonia or active tuberculosis


eligible ages (years): 18.0-999.0,  All  Psoriasis Subjects are non-immunocompromised males or females 18 years of age or older Subjects have moderate-to-severe (≥10% total body surface area) plaque psoriasis Subject diagnosed at least 6 months prior to entering the study Negative urine pregnancy test within 7 days before the first dose of ustekinumab in all women (except those surgically sterile or at least 5 years postmenopausal) Sexually active subjects of childbearing potential must agree to use medically acceptable form of contraception during screening and throughout the study Are considered eligible according to the following tuberculosis (TB) screening Have no history of latent or active TB prior to screening. An exception is made for subjects currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent Within 1 month prior to the first administration of study agent, have a negative QuantiFERON-TB Gold test result, or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. The QuantiFERON-TB Gold test are not required at screening for subjects with a history of latent TB and ongoing treatment for latent TB or documentation of having completed adequate treatment as described above; Subjects with documentation of having completed adequate treatment as described above are not required to initiate additional treatment for latent TB  Subject is younger than 18 years of age Subject has less than 10% body surface involvement of his/her psoriasis Subjects with erythrodermic, pustular, or guttate psoriasis History of known or suspected intolerance to any of the ingredients of the investigational study product Evidence of skin conditions other than psoriasis that would interfere with study-related evaluations of psoriasis Evidence of active infections such as fevers, chills, sweats, or history of untreated Lyme disease and active severe infections within 4 weeks before screening visit, or between the screening and Week 0 visits Subject has a history of listeriosis, untreated TB, persistent or active infections requiring hospitalization or treatment with IV antibiotics, IV antiretrovirals, or IV antifungals within 30 days of baseline, or oral antibiotics, antivirals, or antifungals for purpose of treating infection, within 14 days of baseline Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening Refer to for information regarding with a history of latent TB Have had a Bacille Calmette-Guerin (BCG) vaccination within 12 months of screening


eligible ages (years): 18.0-65.0,  All  Cystic Fibrosis Healthy control subjects Age 18-65 No history of lung disease Cystic fibrosis subjects Age 18-65 No history of lung disease other than cystic fibrosis Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis  Use of recreational drugs within 30 days prior to enrollment Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history Pregnant or lactating females


eligible ages (years): 18.0-999.0,  All  Scalp Psoriasis Plaque Psoriasis Capable of giving informed consent and the consent must be obtained prior to any study related procedures Be 18 years of age or older at the time of consent; may be male or female Have had a diagnosis of plaque psoriasis at least 6 months prior to administration of study agent Presence of moderate or severe psoriasis on the body other than the scalp At least 30% of scalp affected with erythema, induration and desquamation and s-PGA score greater than or equal to 4 Be candidates for phototherapy or systemic treatment of psoriasis Women of childbearing potential and all men must be using adequate birth control measures (eg abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent Be able to adhere to protocol requirements and study visit schedule Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection  Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB Have screening laboratory test results within the following parameters Hemoglobin > 10g/dL White Blood Cells > 3.5 x 109 /L Neutrophils > 1.5 x 109 /L Platelets > 100 X109 /L Serum Creatinine < 1.5 mg/dL ( or 133 micromol/L ) AST,ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test Subjects meeting any of the following may not be enrolled in the study Currently have non-plaque forms of psoriasis (erythrodermic, guttate, or pustular)


eligible ages (years): 12.0-999.0,  All  Cystic Fibrosis Aspergillus Infections Patient with cystic fibrosis men or women age equal greater to 12 years presenting with a positive sputum culture for Aspergillus confirmed twice within 6 months before study entry and at initial visit written informed consent  patients with a contraindication to one of the antifungal agents evaluated pregnant women or nursing mothers absence of an effective method of contraception in women of child-bearing potential patients with signs or symptoms of invasive aspergillosis patients with signs or symptoms of aspergilloma patients with an infection caused by Burkholderia complex Cepacia or to mycobacteria lung transplant patients, registered on a transplantation waiting list or whose registration is imminent patients who received systemic antifungal therapy for more than 5 days within 2 months prior to patients currently enrolled in another clinical drug trial ongoing treatment with medicinal products contraindicated with itraconazole and voriconazole or with major interactions which reduce azole concentrations


eligible ages (years): 3.0-17.0,  All  Invasive Pulmonary Aspergillosis Lymphoblastic Leukaemia Myeloblastic Leukaemia Lymphoblastic Leukemia Myeloblastic Leukemia Age: patients between 3 and 18 years Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy Informed consent of parents/guardians and/or assent of the patient has been obtained  Probable or proven invasive pulmonary fungal infection before entering the trial Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL Severe hepatic impairment Moderate-severe asthma being treated pharmacologically Antifungal treatment for filamentous fungi in the last 4 weeks Participating or have participated in a clinical trial during the last 4 weeks Mentally retarded Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients Any serious concomitant disease that in the investigator's opinion could compromise the completion of the trial or affect the patient's tolerability to this treatment Pregnancy (in women of fertile age)


eligible ages (years): 18.0-75.0,  All  Pulmonary Tuberculosis (TB) HIV negative patients, adult patients >18 years who has not started anti-TB therapy Newly diagnosed pulmonary TB confirmed by microscopy or culture but also sputum-negative clinical TB cases (defined according to the WHO 2006 for sputum smear-negative TB ie. clinical symptoms of TB, chest X-ray findings and response to standard treatment)  Patients who have already started treatment with anti-TB drugs for more that 5 days HIV-positive patients History of anti-TB treatment in the past 2 years Local extra-pulmonary TB in the absence of lung manifestations Hypercalcaemia (serum calcium > 2.6 mmol/L) identified at baseline Pregnant and breast feeding women Any known liver or kidney function abnormality, malignancy or patients treated with cardiac glycosides


eligible ages (years): 18.0-999.0,  All  Infections Signature of informed consent to participate in the study Adult patients (> 18 years), diagnosed with acute myelogenous leukemia or myelodysplastic syndrome with chemotherapy (CT) intensive, or admitted to undergo allogeneic hematopoietic progenitor cells, or transplantation with graft versus host disease The patient should be included in this protocol from the start of their chemotherapy or conditioning therapy as reflected in another section  Employment of antifungal prophylaxis (30 days prior to inclusion) with triazole / polyene with activity against Aspergillus (itraconazole, voriconazole, posaconazole, amphotericin B inhalation) Use of other systemic antifungal activity against Aspergillus (amphotericin, terbinafine, flucytosine, echinocandins, etc.). Therefore it will Fluconazole prophylaxis exclusively Background of IFI proven / probable prior Probable IFI / tested at the time of in the study will cause a lack of compliance with the criteria Patients who have a lack of follow biweekly with galactomannan or PCR. Have a bacterial infection not properly treated and controlled before starting empirical antifungal treatment (according to the definition given above). And finally they have a neutropenia of short duration that it creates a significant risk of IFI. This information will not be known logically to the patient in the study


eligible ages (years): 1.0-16.0,  All  Pediatric Urinary Lithiasis The patients with pediatric urinary lithiasis  Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system


eligible ages (years): 18.0-999.0,  All  Survival After IPA Risk Factors for IPA > 18 years positive aspergillus culture in respiratory tract sample OR positive aspergillus galactomannan in respiratory tract sample  no inform consent age < 18 years


eligible ages (years): 18.0-999.0,  All  Immunocompromised Patient Aspergillosis Fusarium Any adult ≥18 years old Patients where a new course of voriconazole is indicated for suspected or confirmed invasive aspergillosis or other serious fungal infections that is deemed by the treating physician to be susceptible to voriconazole Patients must have venous access to permit the administration of voriconazole and enable the procurement of multiple plasma samples to measure voriconazole concentrations Estimated creatinine clearance ≥ 50 mL/min Able to give written informed consent Considered fit to receive the trial treatment Able to remain in the hospital for at least 5 days or until they complete their trial treatment Female patients must satisfy the investigator that they are not pregnant, or are not of childbearing potential, or are using adequate contraception Men must also use adequate contraception  Patients with an estimated creatinine clearance < 50 mL/minute (this precludes the use of intravenous voriconazole) Patients receiving any form of renal replacement therapy i.e. haemodialysis or haemofiltration Patients with hepatic insufficiency Female patients that are pregnant, breast feeding or planning pregnancy during the study Past history of intolerance to voriconazole Age <18 Evidence of a clinically relevant fungal isolate that is resistant to voriconazole QT prolongation on ECG Use of other medications that contraindicate the use of voriconazole Patients receiving any other medications that are contraindicated with the use of voriconazole i.e. terfenadine, long acting barbiturates, ergot alkaloids, etc. (Refer to SMPC). Only patients on rifampicin, rifabutin, phenytoin, and carbamazepine would have voriconazole precluded. Voriconazole influences with the pharmacokinetics of many additional agents


eligible ages (years): 18.0-999.0,  All  Lung Transplant Infection Lower Respiratory Tract Infection. Post bilateral sequential lung transplant Capable of performing airway clearance techniques / nebulisers Pulmonary exacerbation as defined by Fuchs et al Must be productive of sputum Able to provide informed consent within 48 hours of presentation *Fuchs Scale(8): Treatment with / without parenteral antibiotics for 4/12 signs and symptoms Change in sputum New or increased haemoptysis Increased cough Increased dyspnoea  Paediatric transplant <18yrs Single lung transplant native lung physiology may confound outcome measures Interstate unable to complete follow up Unable to perform lung function testing Unable to complete subjective outcome measures unable to read English fluently Critically unwell / ICU / ventilator dependent Within 2 months of transplant date *Cystic Fibrosis will be stratified


eligible ages (years): 18.0-40.0,  All  Healthy Aged from 18 to 40 years old, age difference is not more than 10 years old within the same batch of healthy volunteers, the male to female ratio of cases is 1:1. Body mass index should be in the range of 20 to 27 Body Mass Index BMI: weight (Kg)/ height (M2) Agreed to participate in the test and sign the informed consent Subjects should comply with the requirements of the clinical trial protocol and be followed Subjects have no history of TB (Tuberculosis)or family history of tuberculosis People have no pulmonary tuberculosis or extrapulmonary tuberculosis,respiratory symptom or systemic symptoms People have no tuberculosis focus after examination by X-ray chest radiograph and sputum bacilli Subjects have no acute or chronic disease, acute infectious diseases, dermatoses or skin allergy caused by various reasons Physical condition: have no history of heart, liver, kidney, gastrointestinal tract, nervous system, or metabolic disturbance, etc. ECG, blood pressure, heart rate, respiratory status and lab test indexes including blood, urine, liver and kidney function, etc are all normal within 4 weeks before screening No close contacts of tuberculosis Subjects have not participated in other clinical drug trials or inoculated against other prophylactic and immune globulin in the nearly 3 months  Health people have close contacts of TB (Tuberculosis)patients, especially excreter in 3 weeks before selection Suffering from any other serious disease, e.g. during cancer treatment, autoimmune disease, progressive atherosclerosis, diabetes accompanied with complications, chronic obstructive pulmonary disease (COPD) needing oxygen therapy, acute or progressive liver or kidney disease, congestive heart failure, etc People have history of allergy, convulsions, epilepsy, cerebropathy, neurological symptoms and signs Patients who have impaired or abnormal immune function, e.g. patients treated with immunosuppressor or immunopotentiator, received immunoglobulin preparation or blood products or plasma extraction outside the gastrointestinal tract in 3 months, human immunodeficiency virus or related diseases Acute febrile illness and infection Taking part in other clinic trials Subjects have participated in any other clinical drug trials in 3 months before our clinical tests Allergic constitution, e.g. patients have allergic history to two or more kinds of drugs or food, or drug components Substance abuse and alcoholics  Pregnant or breast feeding women


eligible ages (years): 18.0-65.0,  All  Dental Caries Two approximal carious lesions on different teeth with at least one tooth in between Both study lesions must not require an invasive treatment Size and form of the lesions: the lesions must be fully visible and assessable on radiographs The two carious lesions must fall into classes D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) Able and willing to observe good oral hygiene throughout the study Age ≥ 18 years and ≤ 65 years Willing and able to attend the on-study visits Willing and able to understand all study-related procedures  The two study test lesions are located on adjacent teeth Fluoride varnish application < 3 months prior to study treatment Tooth with numerous carious lesions Evidence of tooth erosion History of head and neck illnesses (e.g. head/neck cancer) Any pathology or concomitant medication affecting salivary flow or dry mouth Any metabolic disorders affecting bone turnover Patient suffers from diabetes Concurrent participation in another clinical trial Women who are breast-feeding, pregnant or who plan a pregnancy during the study


eligible ages (years): 18.0-65.0,  All  Dental Caries Two approximal carious lesions on different teeth with at least one tooth in between Both study lesions must not require an invasive treatment Size and form of the lesions: the lesions must be fully visible and assessable on radiographs The two carious lesions must fall into classes D1 (outer half of enamel) D2 (inner half of enamel) D3 (outer part of dentine) but only if very little dentine is involved (enamel-dentine junction) Able and willing to observe good oral hygiene throughout the study Age ≥ 18 years and ≤ 65 years Willing and able to attend the on-study visits Willing and able to understand all study-related procedures Written informed consent before participation in the study  The two study test lesions are located on adjacent teeth Fluoride varnish application < 3 months prior to study treatment Tooth with numerous carious lesions Evidence of tooth erosion History of head and neck illnesses (e.g. head/neck cancer) Any pathology or concomitant medication affecting salivary flow or dry mouth Any metabolic disorders affecting bone turnover Patient suffers from diabetes Concurrent participation in another clinical trial Women who are breast-feeding, pregnant or who plan a pregnancy during the study


eligible ages (years): 30.0-60.0,  All  Type 2 Diabetes Mellitus Pulmonary Tuberculosis Age 30 to 60 years Patients having both TB and type 2 DM Patients consenting to participate No history of previous ATT Plane to have ATT and DM treatment  Age less than 30 years or greater than 60 years Pregnant women Patients having either TB or type 2 DM Patients refuse to participate Patients having extra-pulmonary TB or Multi-drug resistant MDR TB or relapse cases Patients having hepatic or renal diseases or HIV infection Patients having hypo or hyper-parathyroidism Patients on corticosteroids or immunosuppressive or thiazides diuretics or any other drugs known to interfere with vitamin D levels


eligible ages (years): 18.0-65.0,  All  Influenza with confirmed influenza A(H1N1,H3N2) or influenza B virus infection by real time RT-PCR (rRT-PCR), age between 18-65 years old, axillary temperature ≥38ºC and with at least two constitutional symptoms (headache, chill, myalgia ，or fatigue) and one respiratory symptom (cough ，sore throat,or coryza) . Illness onset had to be within 36 hours, and informed consent was obtained  age younger than 18 or older than 65 years old patients confirmed with bronchitis, pneumonia,pleural effusion and interstitial lung disease by Chest imaging (chest X-ray or CT)  Blood routine screening tests shows numeration of leukocyte 10.0×109/L or Neutrophil percentage ≥80% Those have got suppurative tonsillitis or cough purulent sputum Those with underling primary disorders, such as hematological disease, chronic obstructive pulmonary disease（FEV1/FVC＜70％，FEV1/ predicated value＜50％； or respiratory failure or right heart failure）， hepatic disease（ALT or AST≥triple ULN）, renal disease（Serum Creatinine＞2mg/dL）,chronic congestive heart failure( NYHA Ⅲ-IV) Patient is allergic to the study medication(s). 8. Women who are pregnant or may possibly become pregnant or are lactating with a positive urine pregnant test, obesity (abody mass index (BMI) of 25 kg/m2 or more) Those with immunodeficiency ,such as malignant tumor ; Organs or bone marrow transplantation ; AIDS ;or taking immune inhibitors during the last 3 months Doubt or does alcohol/drug abuse of history. 11. Those have participated in other clinical trial within three month before study randomization Two weeks before the test , those with acute respiratory Infection，otitis,or nasosinusitis  Those already vaccinated or who will receive influenza vaccine. 14.other reasons not suitable for enrollment based on the investigator's discretion


eligible ages (years): 30.0-85.0,  All  Invasive Pulmonary Aspergillosis COPD Cases of invasive pulmonary aspergillosis secondary to COPD  Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment Known allergy to voriconazole Severe impairment of live or kidney function Septic shock Unwilling to sign informed consent


eligible ages (years): 18.0-999.0,  All  Cholecystitis Signed informed consent All patients deemed to have a clinical and surgical indication to undergo a LESS cholecystectomy  Pregnancy Breastfeeding BMI>35 Serious comorbidities precluding a LESS cholecystectomy Known or suspected neuromuscular disorders impairing neuromuscular function Allergies to muscle relaxants, anesthetics or narcotics utilized for this study A (family) history of malignant hyperthermia A contraindication for neostigmine administration Chronic opioid use Prolonged QT syndrome


eligible ages (years): 40.0-75.0,  All  COPD(Chronic Obstructive Pulmonary Disease) Clinical diagnosis of COPD according to GOLD 2013  A history of asthma or other chronic lung diseases Take Antioxidant therapy There are new or recurrent symptomatic myocardial ischemia, severe arrhythmia, cardiac insufficiency cerebrovascular disease Senile dementia or cognitive impairment cancer Severe liver and kidney and other viscera function insufficiency Language communication barriers Limb activity disorder The last 3 months participated in sports training


eligible ages (years): 18.0-999.0,  All  Chronic Obstructive Pulmonary Disease Established diagnosis of COPD by medical doctor (based on clinical history or pulmonary function test) Smoking history of at least 10 pack-years CT Thorax available for assessment of bronchiectasis FEV1 >= 30%  Mechanical or non-invasive ventilation Other main respiratory diagnosis other than COPD Active mycobacterial disease Immunosuppression other than steroids Active cancer treatment


eligible ages (years): 18.0-65.0,  All  Tuberculosis Age 18 to 65 years with body weight from 30 kg to 90 kg Sputum acid-fast bacilli (AFB) smear positive (at least 1+ on the WHO International Union Against Tuberculosis and Lung Disease scale) Likely able to produce approximately 10 mL of sputum per day Xpert MTB/RIF-confirmed M.tb Rifampin-sensitive pulmonary tuberculosis as indicated by Xpert MTB/RIF Isoniazid urine screen negative ALT < 3X upper limit of normal, creatinine < 2X upper limit of normal Willingness to have samples stored  Clinically suspected disseminated TB or acuity of illness too much as deemed by clinicians Has been treated for tuberculosis within the past 3 years Treatment with agents known to have anti-tuberculosis activity (e.g., fluoroquinolones, linezolid) for any indications during the current episode of clinical illness or within 2 months prior to screening, whichever is longer Cirrhosis or chronic kidney disease Disease complications or concomitant illness that might compromise safety or the interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g., sarcoidosis, rheumatoid arthritis, and connective tissue disorder) Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within 2 weeks prior to screening Subjects with diabetes, point of care HbA1c above 6.5, or random glucose over 200 mg/dL Conditions which compromise the subject s ability to take or absorb oral drugs Normal PA-Chest radiograph, determined during screening Total lung (left or right) collapse on PA-Chest radiograph


eligible ages (years): 18.0-99.0,  All  Tuberculosis At least 18 years of age Diagnosis of TB (and/or NTM for NIH clinical center subjects) Ongoing signs and/or symptoms of pulmonary TB (and/or NTM at the NIH CC) Suspected drug resistance (drug susceptible allowed at the NIH CC) Available to provide at least 3 sputa over 2 or more days Taking anti-tuberculosis medicines (or NTM meds at NIH CC) during the time sputa are provided Thought likely to be Mycobacterium culture positive (including NTM infected for the NIH CC) by enrolling physician GeneXpert MTB/RIF sputum TBpositive (China subjects only) Likely able to produce sputum samples while on study Willing to provide blood samples  Acute liver or kidney disease Conditions which compromise the subject s ability to take or absorb oral drugs


eligible ages (years): 15.0-999.0,  All  Cystic Fibrosis Patient Patient Without Treatment Against A.Fumigatus Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier Patient aged 15 or over Patient able to understand the nature, purpose and methodology of the study Patient and his legal representative for minors who have given their free and informed consent Affiliate or beneficiary of a social security scheme  Patients on antifungal treatment at the time of sampling Pregnant or breastfeeding Major protected by law (guardianship, curator or under Backup Justice) Inability to understand the nature and goals of the study and / or communication difficulties with the investigator Subject attending another search including a period of still going to run-in


An 18-year-old male returning from a recent vacation in Asia presents to the ER with a sudden onset of high fever, chills, facial flushing, epistaxis and severe headache and joint pain. His complete blood count reveals leukopenia, increased hematocrit concentration and thrombocytopenia.

eligible ages (years): 14.0-19.0,  All  Healthy Adolescents ages 14-19


eligible ages (years): 18.0-85.0,  All  Malaria, Falciparum Females and males >=18 years of age with uncomplicated, symptomatic malaria as indicated by the presence of both of the following: a.) Blood smears positive for Plasmodium falciparum asexual parasitemia between 1000 -100,000 parasites/mL b.) Fever or history of fever (>= 38.5 C/101.2 F rectal or tympanic; >= 37.5 C/99.5 F axillary or >= 38 C/100.4 F oral) within the prior 24 hours Serum glucose >= 60 mg/dL (by fingerstick or peripheral blood collection) Positive rapid diagnostic test (Binax NOW ICT) for P. falciparum Women of childbearing potential must have a negative urine gonadotropin prior to entry into the study and must agree to use adequate contraception during the entire study  Severe or complicated malaria including subjects with any of the following: a.) Impaired consciousness, seizures or abnormal neurologic exam b.) Jaundice c.) Respiratory distress d.) Persistent vomiting e.) Hematuria, as reported by the patient f.) Parasite density > 100,000 parasites/mL g.) Presence of non-falciparum species on microscopy Pregnant or breast-feeding women History of allergy to or hypersensitivity to azithromycin or any macrolide, sulfonamides, pyrimethamine, or chloroquine Known history of blood dyscrasias (e.g., megaloblastic anemia, agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, hemolytic anemia) History of epilepsy or psoriasis History of treatment with any antimalarial drug (chloroquine, quinine, mefloquine, Malarone, SP, artemisinin compounds) or antibacterial with known antimalarial activity (macrolides, doxycycline, clindamycin) within 2 weeks prior to enrollment into the study Known or suspected cardiovascular, hepatic or renal abnormality that in the opinion of the Investigator would place the subject at increased risk to participate in the study. The following findings are specific exclusions: a.) serum creatinine > 2.0 x ULN b.) ALT and/or AST > 3 x ULN Inability to swallow oral medication in tablet form Treatment with other investigational drugs within 30 Days prior to enrollment into the study Alcohol and/or any other drug abuse


eligible ages (years): 18.0-50.0,  All  Dengue Fever Willing to be followed for the duration of the study Willing to use acceptable methods of contraception Good general health  Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study Liver, renal, or hematologic disease Alcohol or drug abuse within 12 months of study entry History of severe allergic reaction or anaphylaxis Emergency room visit or hospitalization for severe asthma within 6 months of study entry HIV-1 infected HCV infected Hepatitis B surface antigen positive Known immunodeficiency syndrome


eligible ages (years): 18.0-40.0,  All  Viremia Able to understand and give informed consent Age 18-40 years old No medical contraindications to participation discovered at the screening visit Negative serologic test for HIV, HCV and Hepatitis B surface antigen at the screening visit Female volunteers of childbearing potential must agree to use effective birth control throughout the duration of the study. A negative urine pregnancy test must be documented prior to any injection Must weigh at least 110 lbs  Any history of allergy or history of anaphylaxis to any of the vaccine components Any history of allergic reaction to human immune globulin or a history of IgA deficiency History of hypersensitivity to ingestion of eggs or allergic reaction to vaccines prepared in eggs or chick embryo cell cultures (e.g. influenza, measles) Known or suspected immunodeficiency (e.g. HIV infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids> 10 mg prednisolone/prednisone, or equivalent, for mare than 14 days in the last three months). Persons with previous skin cancer or cured non-lymphatic tumors are not excluded from the study Any clinically significant chronic medical condition that is considered progressive including: hypertension, diabetes, gastrointestinal abnormalities (e.g. active peptic ulcer disease), cardiac, pulmonary, hepatic, renal, or neurologic disease History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions, or occupational requirements that in the opinion of the investigator would preclude compliance with the trial Receipt of any live or inactivated vaccine between the screening visit and the day 0 visit, or any vaccine within 30 days of a vaccination visit Any subject found to be HIV positive, hepatitis B surface antigen positive, or hepatitis C antibody positive at the time of screening Any contraindication to intramuscular injection Women who are pregnant, nursing or expect to become pregnant during the study period


eligible ages (years): 11.0-14.0,  All  HIV Infections Clinically-identified HIV-1 infected participants 11-14 years of age and their primary caregivers HIV status has been disclosed to the adolescent Caregiver is the legal guardian of the adolescent as indicated by the medical team Adolescent lives with the caregiver Adolescent and caregiver speak and understand English  Caregiver consent or permission denied or adolescent does not assent Adolescent diagnosed as mentally retarded as previously reported or confirmed through chart review Adolescent and/or caregiver too medically fragile. Medically fragile is functionally defined as being physically unable to attend the group


eligible ages (years): 18.0-50.0,  All  Dengue Available to participate for the duration of the study (approximately 12 months) Completion and review of knowledge assement quiz  Pregnant (by history or as ascertained by pregnancy test) or lactating female Female who intends to become pregnant during the study Plan to have elective surgery during the study period HIV infection Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed) History of splenectomy Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination Evidence of active (acute or chronic) hepatitis B or C infection Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening


eligible ages (years): 18.0-50.0,  All  Dengue Hemorrhagic Fever Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine General good health Available for the duration of the study Willing to use accepted forms of contraception  Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study Certain abnormal laboratory values Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry History of severe allergy or anaphylaxis Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry HIV infected Hepatitis C virus infected Hepatitis B surface antibody positive Known immunodeficiency syndrome


eligible ages (years): 11.0-70.0,  All  Adolescent Sexual Risk Behaviors Parents of adolescents in grades 6-10 Parents must spend at least two days per week with their adolescents One parent per household/family


eligible ages (years): 18.0-50.0,  All  Dengue Good general health Available for the duration of the study (23 weeks for Cohort 1 and 32 weeks for Cohort 2) Willing to use acceptable forms of contraception for the duration of the study  Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study Significant laboratory abnormalities Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry History of severe allergic reaction or anaphylaxis Severe asthma HIV-1 infected Hepatitis C virus (HCV) infected Hepatitis B surface antigen positive Known immunodeficiency syndrome


eligible ages (years): 18.0-55.0,  All  Typhoid Fever Healthy Males or Females aged 18 to 55 years, inclusive Capable of understanding and complying with the protocol requirements and be available for the duration of the protocol  History of malignancy, immunocompromised conditions or currently receiving immunosuppressive treatment including systemic steroids History of Typhoid Fever infection, vaccination against typhoid fever or participation in a Clinical Trial using S.typhi organism at any time History of travel to a typhoid endemic region within the last 5 years or history of raising a child from an endemic area. Endemic regions are South and East Asia, the Indian Subcontinent, Africa and Central and South America including Mexico History of persistent diarrhea, blood in stool, peptic ulcer disease, or inflammatory bowel disease Allergies or sensitivities to antibiotics, notably quinolones, penicillins, sulfonamides, cefalosporins and chloramphenicol, and components of the buffer solution, notably aspartame People who are commercial food handlers, day care workers, or health care workers involved in direct patient care. Also people with young children under 2 years of age at home or household contacts who are immunocompromised, pregnant or breast-feeding


eligible ages (years): 18.0-45.0,  All  Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Healthy, as determined by medical history, clinical examination, and biological safety parameters Aged 18 to 45 years on the day of inclusion Provision of informed consent signed by the subject or another legally acceptable representative For a woman of child-bearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, and until at least 4 weeks after the last study vaccination Able to attend all scheduled visits and to comply with all trial procedures  Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia For a woman of child-bearing potential, known or suspected pregnancy or positive serum/urine pregnancy test Breast-feeding woman 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 present trial period 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 (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 10 mg). Topical steroids are allowed Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances 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 Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response


eligible ages (years): 12.0-18.0,  All  Post-traumatic Stress Disorder Alcohol Abuse Alcohol Dependence The investigators will screen all English speaking female and male adolescents ages 12-18, who present to Harborview Medical Center with injuries so severe that they require inpatient admission and/or > 24 hour observation in the emergency department All patients where both parents and adolescents consent to the study will be enrolled in the study and randomized  Adolescents who have suffered head, spinal cord, or other severe injuries that prevent participation in the baseline interview will be excluded from the protocol Patients who require immediate intervention (e.g., self-inflicted injury, active psychosis, mania, and victims of family abuse) will be excluded and referred to the Harborview Inpatient Psychiatric Consult Service Patients who are currently incarcerated or are likely to face criminal charges will be excluded


eligible ages (years): 0.0-999.0,  All  Dengue Clinical diagnosis of Dengue Fever


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): 4.0-11.0,  All  Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases Aged 4 to 11 years on the day of inclusion Subject in good health, based on medical history and physical examination Provision of assent form signed by the subject (for subjects ≥ 7 years old) and informed consent form signed by the parent or another legally acceptable representative Subject and parent/ legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures Subject attending one of the schools involved in the trial and living in the Ratchaburi Province 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  Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment For a female subject of child-bearing potential (girls post-menarche), known pregnancy or positive urine pregnancy test on the day of the first trial vaccination Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Receipt of blood or blood-derived products in the past 3 months Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination


eligible ages (years): 12.0-18.0,  All  Anorexia Nervosa Adolescents with anorexia nervosa Ability to preform lung function tests Parents signing informed concent and adolescents signing informed ascent  A history of a lung disease Intercurrent lung illness


eligible ages (years): 12.0-17.0,  All  Depression Suicide for Adolescents Lives at home with at least one parent or guardian Speaks English Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD) for Primary Caretakers Speaks English Current diagnosis of MDD and a history of suicidality  for Adolescents Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible) Only one adolescent per family is eligible for Primary Caretakers Diagnosis of bipolar disorder or substance dependence If taking antidepressants, not on a stable dose for 3 months


eligible ages (years): 18.0-999.0,  All  HIV Infections Pneumococcal Infections Male or female subjects aged 18 years or older at the time of enrollment All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)  Subjects with active AIDS related illness, including opportunistic infections or malignancy Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment Contraindication to vaccination with pneumococcal conjugate vaccine Previous anaphylactic reaction to any vaccine or vaccine-related component History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.) Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease)


eligible ages (years): 18.0-48.0,  All  Japanese Encephalitis All aspects of the protocol explained and written informed consent obtained from the participant Aged ≥18 to < 49 years In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results Participant must be available for the study duration, including all planned follow-up visits Participant must agree to take the following precautions to avoid insect bites for 7 days following vaccination by using N,N-diethyl-meta-toluamide (DEET)-containing insect repellent, where appropriate For female participants: Negative pregnancy tests at Screening and Day 0, in conjunction with a menstrual and contraceptive history indicating a low probability of pregnancy in the opinion of the physician. Females of childbearing potential will be required to be correctly using an efficacious hormonal method of contraception or intrauterine device for at least 1 month before randomisation and during the on-study phase to Day 30. Barrier methods of contraception will not be considered acceptable for study entry. Female participants of child-bearing potential will sign an agreement that contraception will be correctly practised during the specified periods and will specify the method used. Female participants unable to become pregnant must have this documented (e.g., tubal ligation, hysterectomy or postmenopausal [at least one year since last menstrual period])  A history of vaccination or infection to Japanese encephalitis (JE) or yellow fever (YF) or other flaviviruses (including Japanese encephalitis, tick-borne encephalitis, St Louis encephalitis, West Nile virus, dengue fever, Murray Valley encephalitis). Previous vaccination will be determined by history (interview of subject) Previous or current military service History of residence in or travel to flavivirus endemic areas in the tropics (Cape York region of Northern Queensland, India, Southeast Asia, Central America, Caribbean or South America) for periods of 4 weeks or more Known or suspected immunodeficiency (e.g., human immunodeficiency virus [HIV] infection, primary immunodeficiency disorder, leukemia, lymphoma), use of immunosuppressive or antineoplastic drugs (corticosteroids > 10 mg prednisone, or equivalent, in the last three months or during the trial (up to Day 30) History of thymoma, thymic surgery (removal) or myasthenia gravis Clinically significant abnormalities on laboratory assessment (i.e., meeting the mild, moderate or severe described in the toxicity gradings for laboratory values) Anaphylaxis or other serious adverse reactions characterised by urticaria or angioedema to foods, hymenoptera (bee family) stings, or drugs (including vaccines) Transfusion of blood or treatment with any blood product, including intramuscular or intravenous serum globulin within six months of the Screening Visit or up to Day 30 Administration of another vaccine or antiviral within 30 days preceding the screening visit or up to Day 30 (these subjects will be rescheduled for vaccination at a later date) Physical examination indicating any clinically significant medical condition