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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): 18.0-999.0, 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) | 0 |
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): 12.0-999.0, 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 | 0 |
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): 3.0-17.0, 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) | 0 |
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): 18.0-75.0, 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 | 0 |
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): 18.0-999.0, 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 | 0 |
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): 1.0-16.0, Pediatric Urinary Lithiasis The patients with pediatric urinary lithiasis Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system | 0 |
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): 18.0-999.0, 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 | 2 |
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): 18.0-999.0, 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 | 1 |
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): 18.0-999.0, 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 | 0 |
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): 18.0-40.0, 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 | 0 |
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): 18.0-65.0, 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 | 0 |
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): 18.0-65.0, 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 | 0 |
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): 30.0-60.0, 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 | 0 |
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): 18.0-65.0, 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 | 0 |
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): 30.0-85.0, 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 | 0 |
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): 18.0-999.0, 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 | 0 |
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): 40.0-75.0, 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 | 0 |
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): 18.0-999.0, 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 | 0 |
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): 18.0-65.0, 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 | 0 |
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): 18.0-99.0, 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 | 1 |
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): 15.0-999.0, 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 | 0 |
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, Healthy Adolescents ages 14-19 | 2 |
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): 18.0-85.0, 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 | 1 |
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): 18.0-50.0, 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 | 0 |
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): 18.0-40.0, 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 | 0 |
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): 11.0-14.0, 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 | 0 |
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): 18.0-50.0, 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 | 0 |
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): 18.0-50.0, 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 | 0 |
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): 11.0-70.0, 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 | 0 |
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): 18.0-50.0, 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 | 0 |
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): 18.0-55.0, 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 | 0 |
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): 18.0-45.0, 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 | 0 |
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): 12.0-18.0, 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 | 0 |
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): 0.0-999.0, Dengue Clinical diagnosis of Dengue Fever | 2 |
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): 2.0-11.0, 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 | 0 |
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): 4.0-11.0, 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 | 0 |
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): 12.0-18.0, 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 | 0 |
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): 12.0-17.0, 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 | 0 |
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): 18.0-999.0, 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) | 0 |
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): 18.0-48.0, 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 | 0 |
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): 17.0-65.0, Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative | 0 |
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): 18.0-45.0, Dengue Male or female at least 18 and less than or equal to 45 years old at time of screening In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at day 270) Willing and able to give written informed consent to participate Willing and able to communicate with the investigator and understand the requirements of the study Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two premature ventricular contraction's (PVC's) in a row, or ST elevation consistent with ischemia) Weight: greater than or equal to 110 lb Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders Any history of malignancy with the exception of basal cell carcinoma Previous history , or current diagnosis of diabetes mellitus Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest History of allergy to penicillin, neomycin, streptomycin or gentamicin History of hypersensitivity to any vaccine History of previous vaccination with Yellow Fever (YF) vaccine or Japanese Encephalitis (JE) vaccine or planned receipt of either YF or JE vaccine during the course of the study Previous history of infection with dengue or West Nile or seropositive antibody status to dengue or West Nile virus or participation in a vaccine trial for either of these Travel or planned travel to a dengue-endemic area including the Caribbean, Mexico, Central America, South America or Asia during the study period or in the month prior to screening. An updated map of dengue endemic areas is available at the CDC Yellow Book 2010 website (http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-5/dengue-fever-dengue-hemorrhagic-fever.aspx) and a list of dengue endemic countries is provided in the Manual of Procedures (MOP) | 0 |
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): 0.115-45.0, Typhoid Fever Main Subjects belonging to 4 age groups will be enrolled into the trial: adults (18 to 45 years of age), children (24 to 59 months of age), older infants (9 to 12 months of age at enrollment) and infants (6 weeks of age at enrolment) Written informed consent will be obtained by the all subjects or their parents/ guardians (depending on the age group) before enrollment into the trial Only females with a negative pregnancy test and willing to participate in family planning consultations (organized by the site study team) will be allowed to participate to the trial Infants who have been vaccinated with 1 dose of BCG, HBV and OPV at birth can be enrolled into the trial, while infants who have received DTwP+HBV+Hib or OPV due at 6 weeks of age as per local EPI schedule cannot be enrolled into the trial | 0 |
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): 1.0-1.083, Dengue Dengue Hemorrhagic Fever Yellow Fever Aged 12 to 13 months on the day of inclusion Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg as reported by the parent/legally acceptable representative Subject in good health, based on medical history and physical examination Subject has completed his/her vaccination schedule according to the official immunization calendar of Colombia and/or Peru, respectively Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by 2 independent witnesses if required by local regulations) Subject and parent/legally acceptable representative/tutor able to attend all scheduled visits and to comply with all trial procedures Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Planned receipt of any vaccine in the 4 weeks following first trial vaccination Previous vaccination against yellow fever (YF), hepatitis A, or measles, mumps and rubella Receipt of blood or blood-derived products in the past 3 months which might interfere with assessment of the immune response Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 weeks or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Personal known seropositivity for human immunodeficiency virus (HIV) as reported by the parent/legally acceptable representative History of previous maternal vaccination against YF as reported by the parent/legally acceptable representative Personal history of YF or dengue infection/disease as reported by the parent/legally acceptable representative Known systemic hypersensitivity to any of the vaccine components of the vaccines that will be used in the trial, or history of a life-threatening reaction to the vaccines used in the trial or to vaccines containing any of the same substances | 0 |
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): 18.0-50.0, Chikungunya Virus Vaccines, Virus-like Particles Viral Vaccines Humoral Immunity Chikungunya Fever A participant must meet all of the following < TAB> 18 to 50 years old < TAB> Available for clinical follow-up through Week 44 < TAB> Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process < TAB> Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly < TAB> Able and willing to complete the informed consent process < TAB> Willing to donate blood for sample storage to be used for future research < TAB> In good general health, with a BMI less than or equal to 40, without clinically significant medical history, and has satisfactorily completed screening < TAB> Physical examination and laboratory results without clinically significant findings within the 56 days prior to enrollment Laboratory within 56 days prior to enrollment A participant will be excluded if one or more of the following conditions apply Female-Specific < TAB> Woman who is breast-feeding or planning to become pregnant during the time projected for individual study participation < TAB> Systemic immunosuppressive medications or cytotoxic medications within 12 weeks prior to enrollment [with the exceptions that a short course of corticosteroids (less than or equal to10 days duration or a single injection) for a self-limited condition at least 2 weeks prior to enrollment will not study participation] < TAB> Blood products within 16 weeks prior to enrollment < TAB> Immunoglobulin within 8 weeks prior to enrollment < TAB> Prior vaccinations with an investigational CHIKV vaccine < TAB> Investigational research agents within 4 weeks prior to enrollment < TAB> Live attenuated vaccines within 4 weeks prior to enrollment < TAB> Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 2 weeks prior to enrollment | 0 |
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): 18.0-50.0, Dengue Disease Dengue Fever Male or female age 18 to 50 (inclusive) years old at the time of enrollment Have negative anti-dengue, Japanese encephalitis, West Nile, and yellow fever ELISA serological tests Be informed of the nature of the study and provide written informed consent If the subject is of child-producing potential, he/she agrees to practice adequate birth control or abstain from sex Have access to the WRAIR Clinical Trials for at least 270 days, and be willing to refrain from participation in other investigational clinical trials Be in good general health -Subjects meeting any of the following will be excluded from the study History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, yellow fever, and dengue Have a known or suspected hypersensitivity or adverse reaction to vaccines including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0 Have a positive screen for hepatitis B surface antigen (HBsAg), hepatitis C antibody, or HIV antibody Are pregnant or breastfeeding Have donated or received blood, blood products, or plasma within 30 days prior to Day 0 Have any acute illness, including an oral body temperature >100.4°F, within 7 days before the initial injection on Day 0 Have a past or current history of malignant disease except for adequately treated skin cancer Exclusions but are not limited to conditions pertaining to or evidence of immunodeficiency; allergies requiring treatment with antigen injections; autoimmune disease; severe migraine headaches; unstable asthma; clinically significant cardiac arrhythmias, diabetes mellitus, thyroid disease, a bleeding disorder or a seizure disorder | 0 |
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): 11.0-17.0, Immunization Rate Age 11-17 years old Active patient (visit in last 2 years) of clinics in study Need one or more vaccines or well-care visit Up to date on vaccines and well-care | 0 |
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): 65.0-999.0, Pneumococcal Vaccines Pneumococcal Conjugate Vaccine Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component Previous vaccination with any licensed or experimental pneumococcal vaccine Documented Streptococcus pneumoniae infection within the past 5 years Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care | 0 |
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): 1.0-14.0, Japanese Encephalitis Children aged between 1 and 14 years who had clinically diagnosed encephalitis on the basis of history of fever that lasted less than 14 days, altered consciousness with or without a history of new onset seizures with CSF finding of white cell count less than 1000 cells/mm3 with no organisms on Gram stain and a CSF: plasma glucose ratio > 40% admitted in Kanti Children's Hospital and BP Koirala Institute of Health Sciences, Nepal Asexual Plasmodium falciparum parasites in blood Coma appears secondary to other systemic condition, eg hepatic failure, cardiac failure, toxins Patients who have documented antibiotic treatment before admission and in whom partially treated bacterial meningitis appears more likely than encephalitis Children with simple febrile convulsions, defined as a single seizure lasting less than 15 minutes followed by full recovery of consciousness within 60 minutes Pregnant or breastfeeding females Children with a GCS of 3/15, who were receiving artificial ventilation without signs of spontaneous respiration, and with absent oculocephalic reflex | 0 |
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): 7.0-16.0, Dengue Dengue Fever Dengue Hemorrhagic Fever Ongoing participation in study CYD23 at the time of enrollment Assent form has been signed and dated by the subject (for subjects ≥ 7 years old), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and by 2 independent witnesses Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures Planned participation in another dengue clinical trial during the present study Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily | 0 |
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): 18.0-999.0, Diabetic Foot Ulcer Infection Non-hospitalized subjects with Type 1 or Type 2 diabetes mellitus as defined by the American Diabetes Association diagnostic (ADA, 2010). Diabetes may be treated with insulin, oral hypoglycemic agents, diet, or a combination of these therapies. Subjects whose diabetes is considered "controlled" by diet or medication in the opinion of the physician Males or females at least 18 years old Subjects must be considered by the investigator to be reliable, willing and able to give signed informed consent, and must sign the informed consent form Subjects must have a full thickness (i.e., extending through dermis but not involving tendon, bone, or joint capsule) ulcer on the foot distal to the malleoli with a surface area ≥1 cm2 after the wound has undergone appropriate debridement. Subjects must have localized mild infection of the ulcer, as defined by the IDSA as per Appendix C, with in the PGN1300 Protocol, which the investigator believes would ordinarily be treated on an outpatient basis IDSA mild infection of an ulcer is defined as The presence of ≥2 of the following items Local swelling or induration Erythema Local tenderness or pain Local warmth Subjects with IDSA-defined moderate infection as per Appendix C, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; osteomyelitis; gangrene; muscle, joint, or bone involvement Subjects with IDSA-defined severe infection as per Appendix C, within PGN1300 Protocol including systemic toxicity or metabolic instability (e.g., fever, chills, tachycardia, hypotension, confusion, vomiting, leukocytosis, acidosis, hyperglycemia, or azotemia) Subjects with systemic inflammatory response signs, as manifested by ≥2 of the following Temperature >38°C or <36°C Heart rate >90 beats/min Respiratory rate >20 breaths/min or PaCO2 <32 mm Hg White blood cell count >12 000 or <4000 cells/μL or ≥10% immature (band) forms Subjects with local wound complications (e.g., prosthetic materials) Subjects currently receiving antibiotic treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment Subjects requiring concurrent systemic antimicrobials during the study period for any infection, including diabetic foot ulcer | 0 |
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): 14.0-17.0, Overweight Adolescent Behavior Family Research Weight Loss Adolescent ages 14-17 years old living at home with at least one parent/guardian BMI ≥ 85th percentile assent from adolescent consent from a parent/guardian willingness of one parent/guardian living with adolescent to participate in the study English speaking Adolescent BMI ≥ 40 (requires additional medical attention the intervention is unable to provide) previously diagnosed type 1 or type 2 diabetes blood pressure in the range of stage 2 hypertension which requires medication treatment which interferes with outcomes related to blood pressure and glucose medications that significantly interfere with weight gain such as oral steroid use greater than two consecutive weeks antipsychotic medications participation in a standardized weight loss program within the previous 6 months inability to provide informed assent no parent/guardian consent insufficient reading ability to comprehend the self-administered assessment instruments (approximately 5th grade reading level) | 0 |
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): 0.25-16.0, Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening | 0 |
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): 45.0-999.0, Infected by Chikungunya Virus Age at onset of symptoms ≥ 45 years Seen in consultation at the University Hospital of Fort-de-France Suspected chikungunya infection (fever and sudden onset of joint pain affecting the wrists, hands, ankles or knees) Duration of symptoms suggestive of infection chikungunya less than or equal to 10 days Presence of joint pain on the day of No history of inflammatory arthritis Absence of steroidal or non-steroidal anti-inflammatory drugs taken within two weeks prior to Ability to participate in the study throughout its duration (12 months) Patient affiliated or beneficiary of a social health care Acceptance to participate in the study and monitoring proposed and signed informed consent Age at onset of symptoms <45 years Duration of symptoms suggestive of chikungunya for more than 10 days Lack of joint pain on the day of History of inflammatory arthritis Nonsteroidal anti-inflammatory drugs or Taking in the two weeks preceding the Inability to participate in the study throughout its duration (12 months) Patient is not affiliated or beneficiary of a social health care Refusal to participate in the study or to sign a consent | 0 |
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): 18.0-999.0, Influenza clinical presentation that suggest influenza virus infection, including sudden onset of high fever, cough, headache, muscle and joint pain, severe malaise, sore throat and runny nose positive to influenza virus by PCR test anti viral treatment was indicated Immune compromised patients: patients after solid organ transplant, post bone marrow transplantation, with inherited or acquired immune deficiency, or patients treated chronically with immunosuppressive drugs Pregnant women Patients who were treated with oseltamivir in the previous 6 months | 1 |
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): 0.0-999.0, Dengue Fever Stage 1 Discharge diagnosis with International Classification of Disease (ICD) code A90 A99 Availability of minimal dataset (name, IC, age, sex, diagnosis, date admit, date discharge, discharge status) Stage 2 Laboratory confirmed dengue (Non-structural 1 antigen, dengue IgM, high-titre dengue IgG, and dengue polymerase chain reaction (PCR) positive) | 0 |
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): 0.5-50.0, Dengue Subject and/or subject's parent(s)/legally acceptable representative(s) (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol. (e.g., willingness to go to the hospital/clinic for visit[s] in case of AFI, able to observe the signs of dengue and to understand how to take and report body temperature, etc.) Signed/thumb-printed (and video recorded if required by law) informed consent (and assent if applicable) must be obtained from the subject/subject's parent(s)/LAR(s) at the hospital/clinic or during a home visit. If the subject/subject's parent(s)/LAR(s) are illiterate, the informed consent form (ICF) (or informed assent form [IAF] when applicable) will be countersigned by an impartial witness Subject is part of a household with at least one child (aged less than 18 years) and in which informed consent (and assent if applicable) to study participation was obtained from at least one adult and one child Male or female aged between and including 6 months and 50 years at the time of enrolment Subject who plans, at the time of enrolment, to remain at same residence/study area during the two-year study period Child in care Participation (current or planned) in another epidemiological study or in a clinical trial that would conflict with the current study, based on investigator's judgement Terminal illness based on investigator's judgement Mental incapacity based on investigator's judgement | 0 |
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): 18.0-65.0, Dengue Fever Dengue patients confirmed by dengue virus NS1 or RNA Pregnant women Fever diseases caused by other viruses Combined bacterial infection Without complications such as diabetes and tumor | 1 |
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): 13.0-22.0, Dengue Fever Dengue Hemorrhagic Fever Has been identified as a potential subject by the Sponsor and is included in the list provided to the Investigator (i.e., aged 9 to 16 years on the day of first vaccination of CYD dengue vaccine in CYD13/CYD30 and has a post-dose 3 serum sample available [at least 400 µL of serum]) Presently in good health, based on medical history and physical examination Assent form or informed consent form (ICF) has been signed and dated by the subject (based on local regulations), and ICF has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures Subject who received any other dengue vaccination that was not part of the CYD13 and CYD30 trials Subject is pregnant, or lactating, or of childbearing potential (to be considered of non childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia, Pneumocystis Carinii HIV Infections Co-existing Condition Patients with the following are excluded Previous history of adverse reaction to pentamidine History of asthma Pulmonary Kaposi's sarcoma Patients with the following are excluded Previous history of adverse reaction to pentamidine History of asthma Pulmonary Kaposi's sarcoma Inability to understand the consent procedure | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.0-999.0, Spinal Cord Injuries Spinal cord injury of >= 1 year in duration, and no other neuromuscular diseases | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Sepsis Current diagnosis of community-acquired pneumonia Evidence of systemic inflammatory response to infection Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator Presence of organ failure | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 19.0-120.0, Lung Cancer Histologically or cytologically confirmed non-small cell lung cancer Stage IIIA (T1-3, N2) Positive (pathological) ipsilateral mediastinal node Selective stage IIIB meeting all of the following No pleural/pericardial effusion or superior vena cava syndrome T4 due to invasion of carina, trachea, or mediastinal structures Mediastinal N3 nodes (without supraclavicular or cervical adenopathy) Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration) Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry Measurable disease by contrast CT scan allowed | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia years of age or older acute respiratory tract infection patients from outpatient clinics and the emergency department under the age of 18 suspected hospital-acquired pneumonia suspected aspiration pneumonia inpatients | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Greater than or equal to 18 years of age Orally/nasally intubated and receiving mechanical ventilation for <24 hours prior to scheduled randomization and administration of the first dose of Study Drug, and in the judgment of the attending physician, expected to remain intubated and mechanically ventilated for at least 48 hours Expected to survive for at least 21 days and to remain at the investigational site and not transferred to another institution while intubated during the 21-day study period Willing and able to provide written informed consent, or if unconscious or have altered sensorium, have a surrogate provide written informed consent as approved by the institution Negative pregnancy test within 7 days prior to randomization if a female of childbearing potential (Negative pregnancy test results [urine or serum] obtained for reason other than the purposes of this study are acceptable.) Current diagnosis of pneumonia (Patients currently receiving antibiotics for treatment of pneumonia and patients who meet the study definition of clinically defined pneumonia at the time of screening will be excluded.) Absolute neutrophil count less than 1000/mm3 Human immunodeficiency virus infection with a last known CD4 count less than 500/mm3 Recipient of organ transplantation and receiving immunosuppressive therapy Current hematologic malignancy Previously documented cystic fibrosis Severe cranio-facial trauma or other medical condition expected to require imminent tracheostomy Patient, patient’s family and/or physician not in favor of aggressive medical management or presence of an advanced directive to withhold life-sustaining treatment Moribund state or expected to survive less than 21 days due to an uncorrectable medical condition Participation in a clinical trial of any unlicensed drug, biologic or device within 30 days prior to the first dose of study drug | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-35.0, Respiratory Tract Infections Chronic Bronchitis Pneumonia Subjects meeting all of the following will be considered for enrollment into the study Male and female adult outpatient subjects diagnosed with AECB or CAP Female subjects must be either postmenopausal for ≥ 1 year or surgically incapable of bearing children. Women of childbearing potential must have a normal menstrual flow ≤ 1 month before study entry, a negative serum pregnancy test immediately prior to study entry, and meet the for acceptable birth control Informed consent must be obtained in writing for all subjects upon enrollment Subjects will have a diagnosis of AECB or CAP, as defined below AECB-Specific Subjects greater than or equal to 35 years of age Subjects with a documented history of chronic bronchitis: with a basal forced expiratory volume in one second (FEV1) < 70% and > 35%; who have had at least one or more AECB in the previous year; and with FEV1/forced vital capacity (FVC) < 70% Subjects with a clinical diagnosis of AECB, presumed to be due to bacterial infection based on increased sputum purulence with either increased dyspnea or sputum volume Subjects producing spontaneous sputum Subjects presenting with any of the following will not be included in the study Subjects with a known history of congenital long-QTc syndrome Subjects who are pregnant or breast-feeding Subjects who have hypersensitivity to telithromycin, azithromycin, or the macrolide classes of antibiotics Subjects who require or receive treatment with rifampin (Rifadin), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), phenobarbital, or St. John's wort (herbal supplement) within 2 weeks prior to Visit 1 or during the study Subjects who require treatment during the study with ergot alkaloid derivatives, cisapride (Propulsid), pimozide (Orap), bromocriptine, cabergoline (Dostinex), or pergolide (Permax) Subjects who have previously participated in this study Subjects with a previous history of myasthenia gravis Subjects with current acute respiratory failure or subjects who require aggressive airway management Hospitalized subjects and subjects from institutional care facilities | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 64.0-999.0, Pneumonia Lower Respiratory Tract Infection Symptoms or signs of lower respiratory tract infection as defined by standardized criteria Residents were excluded if they were not expected to live longer than 30 days from the date of enrollment, had a previous anaphylactic or serious allergic reaction to quinolones, had advanced directives that they are not be transferred to hospital for treatment | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Mycoplasma Pneumoniae Working at hospital facility where outbreak of Mycoplasma pneumoniae occured Pregnant, on antiseizure medications, allergic to macrolide antibiotics | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 8.0-17.0, Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-17.0, Bacterial Infection Parent or legal guardian has signed the informed consent Age greater than 48 weeks post-conception and less than 18 years of age Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study) Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of "abnormal CXR," the subject will be followed for safety and replaced for analysis) Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage [NB-BAL]) Presence of severe hypoxia (PaO2/FIO2 < 120) Documented or suspected increased intracranial pressure Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL) Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL Coagulopathy Documented platelet count <50,000 x 10^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation) Extra-corporeal circuit, requiring anticoagulation, or | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community-Acquired Pneumonia Age: 18 years and above Clinical and radiological diagnosis of community-acquired pneumonia Informed consent of patient Hospital admission Prior hospital admission (less than 15 days) Alternative diagnosis at the discharge Immunosuppression (HIV infection, immunosuppressive therapies, neutropenia) Risk factors for unusual etiologies Patient is pregnant | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia Community acquired pneumonia Hospitalization Immunocompromised patients Patients under chemotherapy treatment Patients under steroids treament | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Ventilator Associated Pneumonia Respiratory Infection Tracheobronchitis be on mechanical ventilation greater than 3 days greater than or equal to 18 years of age survival greater than 14 days greater than 2 ccs of tracheal secretions/4 hours allergy to drugs, pregnancy | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-70.0, Spinal Cord Injury Chronic spinal cord injury that occurred more than 6 months ago An impaired ability to cough (cough peak flow less than 300 L/min) Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen End-tidal carbon dioxide level less than 43 mm Hg Without a fever or other signs of an acute illness for the previous 2 weeks Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment Under 18 years of age Currently have a tracheotomy tube Have a history of an acute illness in the last 2 weeks Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing Already utilizing an oximetry protocol Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Community Acquired Pneumonia Symptoms of lower airway infection and radiologic sings of pneumonia Age<18 Serious psychiatric illness Mentally retarded Hospitalized last 14 days | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 5.0-999.0, Anemia, Sickle Cell Diagnosis of sickle cell anemia (Hgb SS) or sickle-β0-thalassemia (Hgb Sβ0) Current episode of ACS, defined as a new lobar or segmental pulmonary infiltrate seen on a chest radiograph and two or more of the following findings Temperature of 38.5°C or higher Tachypnea (i.e., rapid breathing) Dyspnea or increased work of breathing Chest wall pain Oxygen saturation of less than 90% in room air by pulse oximetry Current episode of ACS diagnosed in the 24 hours prior to study entry Ability to take medication in capsule form Prior participation in this study Diagnosed with any medical condition that will likely be worsened by corticosteroid therapy, including any of the following conditions Diabetes mellitus High blood pressure Esophageal or gastrointestinal ulceration or bleeding Known avascular necrosis Diagnosis of ACS in the 6 months prior to study entry Treatment with oral or parenteral corticosteroid therapy for any reason in the 14 days prior to study entry Use of inhaled corticosteroids or systemic corticosteroids for respiratory illness in the 3 months prior to study entry Long-term lung condition that requires treatment with corticosteroids | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia, Bacterial Provide signed and dated informed consent Adults, 18 years of age or older of either gender and of any race weighing up to 150 kg. Female patients of childbearing potential MUST be nonpregnant (confirmed by negative serum pregnancy test), nonlactating, and must be willing to practice reliable birth control measures during and for at least 30 days after treatment with study drug(s) Have a new pulmonary infiltrate on chest radiograph Exhibit at least two of the following clinical symptoms of pneumonia on history or physical Cough Production of purulent sputum or change in character of sputum Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness to percussion, bronchial breath sounds, or egophony) Dyspnea or tachypnea Documented fever, defined as body temperature >38.0 ºC (100.4 ºF) taken orally; >38.5 ºC (101.2 ºF) tympanically; or >39.0 ºC (102.2 ºF) rectally or hypothermia, defined as core body temperature of <35.0 ºC (95.0 ºF) An elevated total peripheral white blood cell count (WBC >10,000/mm3); or >15% immature neutrophils (bands), regardless of total peripheral white count; or leukopenia with total WBC <4500/mm3 Patients with Grade V pneumonia (based on Fine Score; Attachment 8) Patients in respiratory failure or incipient respiratory failure if the patient is not a candidate for mechanical ventilation (for any reason) Any of the following pulmonary conditions that may preclude interpretation of study results Cystic fibrosis Primary lung cancer or another malignancy metastatic to the lungs Known bronchial obstruction or a history of post-obstructive pneumonia Known or suspected active tuberculosis Severe shock (systolic blood pressure <90 mm Hg for >30 minutes not corrected by fluid bolus) Clinical evidence of bacterial meningitis (based on lumbar puncture results) Severe renal impairment (calculated creatinine clearance <30 mL/min) | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Post Nasal Drip Postnasal Drip with chronic cough Postnasal drip by rhinoscopy Cough by visual analog scale Patients have to be 18 years old or older Cough-variant asthma must be excluded by a negative methacholine challenge test within one year, or documented failure of chronic cough to resolve after administration of inhaled corticosteroid (> one-month duration). Asthma is defined by the ATS guidelines Subjects must have a negative chest radiogram or Chest CT scan within 6 months No active GERD symptoms (< 7 RSI score) & a stable dose of Proton Pump Inhibitor (4 weeks) of Postnasal Drip without cough Postnasal drip by rhinoscopy No cough by visual analog scale Subject for Postnasal Drip with Chronic Cough Presence of nasal polyposis and/or sinusitis or active GERD symptoms on examination Current smokers (smoking within the 2 months prior to the study) will be excluded Patients with an upper respiratory tract infection within the preceding 8 weeks Patients taking angiotensin converting enzyme inhibitors Patients on leukotriene receptor antagonist and/ or nasal topical corticosteroids or inhaled corticosteroids. Patient must be off nasal or inhaled corticosteroid by at least 4 weeks Same for Post Nasal Drip without cough except A chest radiogram is not necessary in this group Patients taking leukotriene inhibitors, or using nasal steroid therapy | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 13.0-999.0, Ventilator Associated Pneumonia Etiological Organisms Antimicrobial Drug Susceptibility Pattern Stress Ulcer Prophylaxis Age greater than 12 years Those on mechanical ventilation for more than 48 hours Pre-existing pneumonia at the beginning of ventilation or Developing pneumonia within 48 hours of ventilation Patients on oral antibiotics | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 1.0-45.0, Respiratory Sounds Patient and/or parents/guardian signed informed consent Patients with cough or shortness of breath Chest tubes Skin lesions precluding attachment of sensors Respiratory distress Pregnant women | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.0-16.0, Bacterial Infections Bacteremia Meningitis Urinary Tract Infection Mastoiditis Lobar Pneumonia Septic Arthritis Cellulitis Osteomyelitis Positive blood, urine, synovial, bone, pleural effusion, abscess or CSF culture Cellulitis, lobar pneumonia, osteomyelitis | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-5.0, Pneumonia, Bacterial Healthy children aged between 2 months and 5 years attending the well baby clinic in hospital Informed consent obtained from parents or legal guardian | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-4.917, Acute Respiratory Infections Pneumonia Children aged 2 to 59 months attending the outpatient's clinics of participating sites WHO defined non-severe pneumonia Accessibility for follow-up Written informed consent by a parent or legal guardian WHO signs of severe pneumonia recognised by lower chest wall retraction. Children who present with wheezing will be evaluated for lower chest wall indrawing after treatments with nebulised salbutamol. WHO signs of very severe disease/pneumonia defined as any of the following Cyanosis Inability to drink Convulsions Abnormally sleepy or difficult to wake Severe malnutrition recognised by weight for age less than third percentile by the NCHS (National Child Health Statistics) growth chart and/or oedema (see chart) All patients with a previous history of 3 or more episodes of wheeze or diagnosed to have asthma Known or clinically recognisable congenital heart disease with cyanosis or, congestive heart failure or cardiomegaly Known or clinically recognisable acute/chronic organ system disorders including jaundice, nephrotic syndrome, severe anaemia manifested as extreme pallor etc Other infectious conditions requiring antibiotic therapy at the day of contact including meningitis, tuberculosis, dysentery, osteomyelitis, septic arthritis etc | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-80.0, Chronic Cough Healthy Volunteers Over 18 years old Measurable cough reflex sensitivity No current or past history of chronic cough or chronic respiratory disease No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip Chronic Cough Patients Over 18 years old Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post nasal drip and gastro-oesophageal reflux disease Normal CXR Normal lung function Recent Upper Respiratory Tract Infection (4 weeks) Pregnancy/breast feeding Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10 packyears Diabetes Mellitus Opiate or ACE Inhibitor use Any centrally acting medication which has the potential to alter cough reflex sensitivity Significant and ongoing chronic respiratory, cardiovascular (in particular hypertension), gastro-intestinal, haematological (porphyria), neurological or psychiatric illness Drug or alcohol abuse History of allergy or reaction to ketamine of other NMDA receptor antagonists | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.493-999.0, Pneumonia presumed community-acquired pneumonia as diagnosed by the attending emergency department physician age > 6 months immunodeficiency (primary, advanced HIV) cystic fibrosis malignancy known cardiac or lung defects bronchiectasis previous pneumonia or lung abscess in past 6 months conditions requiring treatment with immune suppressants | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia CAP Those pneumonia patients have not been admitted within 14 days before diagnosing pneumonia Those pneumonia patients are not met the of HCAP as stated below HCAP Regular hemodialysis, peritoneal dialysis or infusion therapy (ex TPN, repeated blood transfusion etc ) at a hospital or hemodialysis clinic Receive radiation therapy or chemotherapy at out-patient clinics within 90 days to be admitted to an acute care hospital for two or more days within 90 days before the onset of pneumonia Resided in a nursing home or long-term care The patients with HAP: pneumonia developed two days after admission or within 14 days after discharge (except RCW) VAP: HAP and with mechanical ventilation for at least 48h (except RCW patients) HIV positive with a CD4+ < 200 | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Adult (age>18 years) hospitalized patient with hospital-acquired pneumonia due to Gram negative bacteria pregnancy lactating woman colistin allergy severe renal impairment epilepsy | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 50.0-999.0, Community Acquired Pneumonia Adult subjects 50 years of age or older Subject must reside in the surveillance area Subjects who present to a study healthcare facility where the treating physician clinically suspects CAP Any subject who is transferred to a study healthcare facility after already being hospitalized for 48 hours or more at any other in-patient facility (such as a community hospital) Hospital Acquired pneumonia (ie, develops signs and symptoms of pneumonia after being hospitalized for 48 hours or more) | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Cough Healthy Controls Healthy volunteers Over 18 years Measurable cough reflex sensitivity − required as is the primary end−point No current or past history of chronic cough or chronic respiratory disease Chronic Cough Patients Over 18 years Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for cough variant asthma/post−nasal drip and gastro−oesophageal reflux Normal chest radiograph − primary respiratory cause for cough excluded Normal lung function − primary respiratory cause for cough excluded Measurable cough reflex sensitivity − required as primary end−point Recent upper respiratory tract infection (<4 weeks) − this can lead to increased sensitivity of the cough reflex which resolves as the infection settles Pregnancy/breast−feeding − unknown effects of oesophageal acid infusion Current smokers or ex−smokers with < 6 month abstinence or history > 20 pack years − smoking can alter the sensitivity of the cough reflex Opiate or ACE inhibitor use or centrally acting medication − can alter the cough reflex sensitivity Symptomatic gastro−oesophageal reflux, post−nasal drip or asthma (chronic cough cohort may have been treated for these in the past but cough did not resolve) − these conditions are known to cause cough and alter cough reflex sensitivity Significant ongoing chronic respiratory/cardiovascular/gastro−intestinal/haematological/ neurological/psychiatric illness. We are aiming to recruit healthy volunteers and chronic cough patients who are otherwise healthy | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 1.0-12.0, Pneumonia Children aged 1 to 12 years with acute community-acquired pneumonia (cough, tachypnea, fever and with a chest radiography with lobar, segmental or bronchopneumonia within the first 48 hours) Severely ill patients (hospitalized in intensive care units) Pleural effusion treated with chest drainage Atelectasis detected by x-ray Pneumonia or pleural effusion in the previous six months Other pulmonary underlying disease, heart disease, cerebral palsy or immune deficiency | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-80.0, Sleep Apnea Syndrome Polygraphy Community Acquired Pneumonia Infections Group A Hospital admission and Community acquired pneumonia Nosocomial infections Low level of conscientiousness Neurological disease Impossibility to complete the questionnaires Group B Hospital admission and other infections different to respiratory infections | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Respiratory Tract Infection Adults, equal to or more than 18 years years of age Patients with respiratory tract infections, including any of the following Acute tracheitis, acute tracheobronchitis Acute sinusitis Chronic sinusitis Acute tonsillopharyngitis Acute bronchitis Mild community-acquired pneumonia Acute exacerbation of chronic bronchitis Known hypersensitivity to or previously intolerant of macrolides Illness severe enough to warrant hospitalization or parenteral therapy Concomitant use of any of the following medications Drugs metabolized by CYP3A isozyme: alprazolam, astemizole, carbamazepine, cilostazol, cisapride, cyclosporin, disopyramide, ergot alkaloids, lovastatin, methylprednisolone, midazolam, omeprazole, oral anticoagulants (e.g. warfarin), pimozide, quinidine, rifabutin, sildenafil, simvastatin, tacrolimus, terfenadine, triazolam and vinblastine Drugs metabolized by other isozymes within CYP450 system: phenytoin, theophylline and valproate Colchicine, Digoxin, Some antiretrovirals: zidovudine and ritonavir Severe immunodeficiency and chronic disease conditions Renal or hepatic impairment (creatinine clearance under 30 mL/min, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) equal or more than 3x higher level in comparison with the norm) Mental condition rendering the subject unable to understand the nature of the study | 2 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Ventilator Associated Pneumonia All patients admitted to intensive care units,with score in the Glasgow Coma scale less than nine Requiring mechanical ventilation for more than 48 hours Includes all patients with structural or metabolic coma Pregnant women History of allergic reactions to ampicillin sulbactam Patients admitted as potential organ donors Patients with an indication of antibiotic therapy, or who have received more than 2 doses of any antibiotic previously Hospital stay for more than 48 hours before intubation | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age between 2 to 59 months who present to LHWs with severe pneumonia Informed consent given by a legal guardian Very severe disease Persistent vomiting Parental or caretaker refusal to participate in the study Children currently being treated for non-severe pneumonia who advance to severe pneumonia Suspected or known kerosene oil ingestion Prior enrollment in the study within 2 weeks of last follow up Children with severe malnutrition . Children with severe diarrhea with signs of dehydration | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Pneumonia Male or female patients aged ≧18 years old Patients with nosocomial bacterial pneumonia at least 48 hours after hospitalization or patients with healthcare-associated pneumonia(HCAP*) Clinical findings At least two of the following signs Cough Fever: axillary temperature > 37.5℃ or tympanic temperature > 38.5℃ Hypothermia: axillary temperature < 34℃ or tympanic temperature < 35℃ Purulent sputum production or respiratory secretion Total peripheral white blood cell (WBC) count > 10,000/mm3; or > 15% band forms, regardless of total peripheral white count; or leucopenia with total WBC < 4500/mm3 Auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, or egophony) Woman who are pregnant (determined by urine test) or lactating state Patients with known bronchial obstruction or a history of postobstructive pneumonia. (This does not patients who have chronic obstructive pulmonary disease) A neutrophil count <1000/mm3 Patients with pneumonia due to viral, fungal, or mycobacterial infection Patients who were known to have been infected with human immunodeficiency virus Documented Legionella pneumonia Patients were infected with gram negative (G-) microorganism known to be resistant to one of the study antibiotics during trial Subjects with sputum gram stain of PMN>25, epithelial cell <10, and gram positive (G+) cocci in cluster predominant and phagocytosis Patients who have received any other investigational drug within 30 days prior to enrollment Patients who have received medications like cefoperazone, cefoperazone/sulbactam and cefepime within 30 days prior to enrollment | 1 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.5-1.917, Pneumonia Laboratory Confirmed Influenza Children will be included if they are de jure residents 6 months to 23 months old at the time of first dose vaccination residing in households under surveillance Children will be excluded if they have known chronic respiratory, cardiac, or neurological (including seizure disorders) illnesses, are severely malnourished or require hospitalisation for any other reason, are suspected of having tuberculosis (WHO guidelines) [83], are known to have egg allergy, or parents withhold consent | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 18.0-999.0, Stage III Non-small Cell Lung Cancer Adult patients 18 years and older with histology proven NSCLC with inoperable stage III A or IIIB disease Inoperable stage III A defined by multiple and or/bulky N2 mediastinal lymph nodes on computed tomography (CT) scan such that in opinion of treating investigator, the patient was not a candidate for surgical resection N2 disease must be documented by either biopsy, fluorodeoxyglucose positron emission tomography (PET), and or CT scan if nodes are more than 2 cm Stage IIIB patients must have N3 or T4 status. N3 status must be documented by presence of contralateral (to the primary tumor) mediastinal lymph node or supraclavicular or scalene lymph node proven by either biopsy, fluorodeoxyglucose PET, or more than 2 cm on CT scan No prior treatment for lung cancer ECOG Performance status of 0-1 Initiation of consolidation chemotherapy within 4-8 weeks of concurrent chemo-radiotherapy without progression Adequate organ function leukocytes >3,000/mcL absolute neutrophil count >1,500/mcL Patient who have had prior treatment for lung cancer Prior history of radiation to chest Known malignancy other than the current cancer Uncontrolled intercurrent illness including but not limited to ongoing active infection, history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within last six months or ventricular arrhythmias requiring medication, psychiatric illness that would impair patients ability to comply with study requirements Pregnant or lactating women (any women becoming pregnant during the study will be withdrawn from the study) Patient with documented or symptoms of peripheral neuropathy History of allergic reaction to compounds similar to the ones used in this study Malignant effusions (pleural or pericardial) Superior sulcus (Pancoast) tumors Any condition that would hamper ability to give informed consent or ability to comply with study protocol | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.25-5.0, Streptococcus Pneumoniae Nasopharyngeal Carriage To estimate the nasopharyngeal carriage rate and longitudinal pattern of Streptococcus pneumoniae in healthy children aged less than 5 years living in the area of Milan, Italy To describe the circulation of antimicrobial non-susceptible Streptococcus pneumoniae strains in healthy children aged less than5 years To describe the nasopharyngeal carriage distribution of Streptococcus pneumoniae strains in healthy subjects less than 5 years old To examine the role of risk factors in the Streptococcus pneumoniae carriage rate in healthy children To evaluate the possible impact of vaccination policy in the referenced population | 0 |
A 31 yo male with no significant past medical history presents with productive cough and chest pain. He reports developing cold symptoms one week ago that were improving until two days ago, when he developed a new fever, chills, and worsening cough. He has right-sided chest pain that is aggravated by coughing. His wife also had cold symptoms a week ago but is now feeling well. Vitals signs include temperature 103.4, pulse 105, blood pressure 120/80, and respiratory rate 15. Lung exam reveals expiratory wheezing, decreased breath sounds, and egophany in the left lower lung field. | eligible ages (years): 0.0-2.0, Wheezing Bronchiolitis Age less than or equal to 24 months Presenting to the pediatric ED with wheezing On home oxygen at baseline Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta) Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation Transferred from an outside hospital | 0 |
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