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A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-25.0, HIV Infections H1N1 Influenza Virus for Step I HIV infected HIV-1 was perinatally acquired, in the opinion of the investigator Participants receiving antiretrovirals (ARVs) must have been receiving a stable regimen for 90 days prior to entry with no intention to modify their regimen within 60 days following study entry Participants not receiving ARVs at entry must not have received ARVs within 90 days prior to entry and must NOT plan to initiate ARVs within 60 days following study entry Ability to complete all study immunizations and evaluations, in the opinion of the investigator Agrees to use contraception, if necessary Documented platelet count of more than 50,000 per mm3 and an absolute neutrophil count (ANC) of more than 500 per mm3 within the 30 days prior to study entry Youth of legal age (from 18 to 25 years of age), parent or legal guardian, or participants who are emancipated minors must provide informed consent for Step II Received the first dose of Influenza A (H1N1) 2009 monovalent vaccine at least 21 days ago for Step I Pregnancy Known allergy to egg protein (egg or egg product) or other components in the vaccines (these may but are not limited to: neomycin and polymyxin) History, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal influenza vaccines that would contraindicate receipt of any influenza vaccine History of probable or proven pandemic 2009 Influenza A (H1N1) infection prior to study entry Has received any live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry Has received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to study entry or expects to receive another nonlicensed agent during the course of the study Has an acute illness or a documented temperature greater than or equal to 100.0 degrees Fahrenheit within 24 hours prior to study entry Use of anti-cancer chemotherapy or radiation therapy within the 36 months preceding study entry or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection) Has an active neoplastic disease | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Healthy Volunteers NIH employees scheduled to receive the H1N1 vaccine through OMS Healthy status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol Age 18 years and older (no upper limit) Able to comprehend the investigational nature of the protocol and provide informed consent Recipient of another vaccine or immune modulating drug within 6 months prior to study entry. Seasonal influenza vaccine may be administered up to 3 days prior to enrollment or after completion of study participation (day 7 blood draw) Confirmed influenza within the past 1 year Severe allergies to eggs or their products Prior severe reactions to vaccines Participation on any blood collection or blood donation procedure during study that will bring the total blood draw > 550m1 over 8 weeks Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Physical Activity Resident of Senior housing Ability to engage in mild exercise Vision sufficient to view TV medium Willingness to engage in tai chi/qigong training and practice Unable to provide informed consent Unable to attend initial training session | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Acute Lithiasic Cholecystitis Grade I or II Symptoms Lasting for Less Than 5 Days Required Cholecystectomy Preoperative Amoxicillin Clavulanic Acid for at Most 5 Days Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder) Requiring early cholecystectomy (progression of symptoms <5 days In an adult patient (>18 years) For each patient included the consent form must have been read, understood and signed Severe acute cholecystitis (with organ dysfunction) Acalculous cholecystitis Biliary peritonitis Abscess perivesicular Cholangitis Acute Pancreatitis Septic shock Stone of bile duct Physical or mental state does not allow participation in the study Contraindication to surgery | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 21.0-999.0, Breast Cancer Female Histologically proven stage 0-III invasive carcinoma of the breast that is ER and/or PR positive by immunohistochemical staining, who are receiving a standard dose of aromatase inhibitor (AI) therapy (letrozole 2.5mg once daily or exemestane 25mg once daily or anastrozole 1mg once daily). Women with oligometastatic disease may be included at the discretion of the principal investigator. Surgical resection, chemotherapy, and radiation therapy must have been completed at the time of study enrollment, with the exception of trastuzumab AI therapy has been ongoing for ≥ 2 weeks and treatment is expected to continue AI-associated musculoskeletal symptoms, defined as Grade 1 or higher musculoskeletal pain that developed or worsened (6 or 7 on CGICS) during AI therapy or Grade 1 or higher sensory neuropathy that developed or worsened (6 or 7 on CGICS) during AI therapy Average pain of ≥4 on the 11-point Likert scale of question #5 of the Brief Pain Inventory ECOG performance status 0-2 Willing and able to sign an informed consent document Known hypersensitivity to duloxetine or any of the inactive ingredients New musculoskeletal pain that is due specifically to fracture or traumatic injury Treatment with monoamine oxidase inhibitors (MAO-I) within 14 days of enrollment Concurrent treatment with phenothiazines (including thioridazine), propafenone, flecainide, triptans, MAO-Is, SSRIs, SNRIs, or tricyclic antidepressants Currently primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder Chronic liver disease, end stage renal disease, or creatinine clearance < 30 mL/min as defined by the Cockroft-Gault equation Uncontrolled narrow-angle glaucoma or clinically significant coagulation disorder Pregnant or breast feeding History of alcohol or other substance abuse or dependence within the year prior to enrollment Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 6.0-999.0, Influenza A Virus, H1N1 Subtype Clinical diagnosis of severe pandemic H1N1 influenza patients and pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza Rapid Diagnostic Tests:positive Age≥6 years Influenza symptoms occurred less than 48 hours and body temperature≥37.5℃ for pandemic H1N1 influenza patients with risk factors for severe H1N1 influenza Suffering from mental illness Attending other clinical studies on influenza Critical pandemic H1N1 influenza patients | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-999.0, Acute Respiratory Infection Aged 50 years or older at study entry. 2) Literacy in English language sufficient for understanding the study protocol and completing questionnaires. 3) Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?" 4) Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation. 5) Successful completion of tasks during run-in period, including 2 in-person appointments, 2 phone contacts, and 1 set of homework questionnaires. 6) A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study. 7) A score of 24 points or higher on the Folstein mini-mental status exam, administered by research personnel at entrance to run-in trial and again just prior to consent and enrollment in the main study. - Physical or medical condition prohibiting adherence to study protocol. Prospective participants must meet the American Heart Association guidelines225 for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment. 2) Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice? 3) Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the BRFSS classification226 system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) >4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week. 4) Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease; Co-Investigator Dr. Muller will advise in questionable cases). 5) Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed. 6) Current use or forecasted need for antibiotic or antiviral medications (eg. prophylactic or suppressive therapy for chronic urinary tract infection, recurrent herpes, or other chronic infections. 7) Malignant disease (prospective participants' physicians to advise. Dr. Barrett to make final decision in questionable cases). 8) Function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). 9) Influenza vaccination (flu shots) within 6 months prior to enrollment. 10) True egg allergy or true allergic reaction to prior flu shot, either of which would have to at least one of the following: a) large rash or swelling (more than 12 inches in diameter), b) any swelling in throat, c) any difficulty breathing, d) reaction with hospitalization, or e) anaphylaxis. Reactions that would NOT people: a) local pain or swelling, b) fever, c) malaise, feeling lousy, or d) cold, flu or other infectious illness | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, HIV Above 18 years of age Stable antiretroviral regimen or not yet in need of treatment (in case of HIV-infected patients) Use of systemic immunosuppressive medication An ongoing infection Recent flu-like symptoms and pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza A Virus/H5N1 Subtype The individual had a clinically compatible illness (defined as respiratory symptoms and an abnormal chest x-ray or encephalitis), AND Influenza A/H5 RNA identified in a clinical sample by reverse transcription-polymerase chain reaction [RT-PCR], OR Influenza A/H5 cultured from a clinical sample, OR High titres (1:80 or higher) of anti-H5 antibodies by microneutralization in convalescent samples of patients who had a compatible illness but no or negative RT-PCR, AND The patient survived or if they died an archived biological specimen is available for potential DNA extraction, AND Valid, written consent is obtained The biological parents and biological siblings of all the cases and any other family members linking two cases, AND Valid, written consent is obtained | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Bacterial Infections Adult volunteers, 18 to 45 years of age, who sign an informed consent form following a detailed explanation of participation in the protocol Volunteers who are in good health as determined by medical history, physical examination and clinical judgement Volunteers who will be available for the duration of the study Volunteers willing and able to give written informed consent Volunteers who are contraindicated for BCG vaccination according to the Manufacturer's Data Sheet Individuals who have hypersensitivity to any component of the vaccine used in this study Individuals who have severe or multiple allergies, including to drugs or pharmaceutical agents Volunteers who are receiving drug treatment for, or who have a significant history of, cardiological or respiratory disease. Volunteers who are suffering from severe cardio-respiratory disease, including hypertension, or an active neurological disorder Individuals found to be HIV antibody positive at screening, or with a known impairment of immune function, or those receiving immunosuppressive therapy, including regular inhaled steroids. Intermittent steroid use (less than twice per month in the preceding 3 months) is acceptable Individuals with acute infections (including fever >38°C) Women who are pregnant or lactating Women capable of becoming pregnant who do not agree to have pregnancy testing before immunisation, and/or who do not agree to take effective contraception for the duration of the study period Individuals with a current problem with substance abuse or with a history of substance abuse, which, in the opinion of the investigator, might interfere with participation in the study Individuals with any condition, which, in the opinion of the investigator, might interfere with the evaluation with the study objectives | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Pelvic Organ Prolapse Female Age ≥ 18 years Have experienced symptoms of overactive bladder (e.g., urinary urgency, frequency, or urge incontinence) for at least 3 months. Specifically women must average 8 or more voids in 24 hours and have 3 or more episodes of urinary urgency or urge incontinence over the 72 hours when the diary is being completed A practitioner trained in the pelvic organ prolapse quantification examination will evaluate each woman's pelvic organ support and vaginal dimensions. Women with a stage 1 or greater vaginal prolapse will be eligible for the study The presence of factors that would contraindicate use of antimuscarinic medications (e.g. urine retention, narrow angle glaucoma, uncontrolled constipation, dementia) An existing condition that would contraindicate use of a vaginal pessary (e.g., patient's vaginal length <6 cm) Patient is currently using a vaginal pessary Patient is unable to tolerate an object in vagina Patient has a history of cervical, vaginal or endometrial cancer Patient is not able to speak English Patient is currently using an anticholinergic medication, or has used one in the past 30 days Patients with mixed urine incontinence that is predominantly stress urine incontinence (determined by their baseline PFDI) Patients with a known allergy to solifenacin Patients with severe hepatic impairment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza subjects with serum HAI titer had at least 1:40 at least 3 weeks after AdimFlu-S (A/H1N1) injection | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-74.0, Cancers Cardiovascular Diseases Cataract Gastrointestinal Diseases Osteoporosis Fractures All women born between 1914 and 1948, living in central Sweden None | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-6.0, Development Coordination Disorder Children with proper( age expected) intelligence and IQ level Study in regular education system The DCD diagnosis must be confirmed by a pediatrician Score above 9 in the Movement Assessment Battery test for Children Score below 3.83 in Children Activity Scale for Parents routinely take medication any physical limitations neurologic and/or muscle disease any significant hearing and/ or vision limitations | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Human Papillomavirus Prevention Mother is greater than or equal to 18 years of age Mother has a daughter who is between the ages of 11-15 years Daughter has not received any doses of the HPV vaccine When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated." Cannot read/speak English | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-65.0, Exercise Sedentary healthy, mobile, 18-65 year old employees who report they are engaging in less than 30 minutes of moderate intensity physical activity per week employees with significant auditory or visual problems and those who have severe musculoskeletal disorders that prevent them from engaging in physical activity. Medical clearance will be requested for those who report any cardiovascular disease | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 55.0-75.0, Type 2 Diabetes woman Type 2 diabetes Menopausal or aged between 55 and 75 years old Recent HbA1c between 6.5-10% Oral anti-diabetic drugs or insulin therapy Hypertension or antihypertensive drug Tobacco Excessive drinking Post-menopausal hormonal treatment Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID Secondary cardiovascular prevention antioxidant using Fish intake >2 times a week Anemia <10g/L Thrombopenia <110g/L Creatinine clearance <30 ml/min and/or proteinuria >1g/L | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Subjects who the investigator believes that they can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male and female adults, 18 to 60 years of age and over 60 years of age Satisfactory baseline medical assessment by history and physical examination Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits Female subjects of non-childbearing potential may be enrolled in the study Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series Participation in previous year's (2009) Fluviral registration study Administration of any influenza vaccine within 6 months preceding the study start (35 or more subjects in the >60 year old age stratum will be recruited from among those who did NOT receive any inactivated influenza vaccine in 2009-2010 season, i.e. seasonal TIV or pandemic H1N1v) Administration of any other vaccine(s) within 30 days prior to study enrollment or during the study period. Subjects who receive such treatment after enrollment will be followed per protocol and included in the safety analysis, but excluded from the according-to-protocol cohort Clinically or virologically confirmed influenza infection within 1 year preceding the study start Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature <38.0°C Significant acute or chronic, uncontrolled medical or psychiatric illness. "Uncontrolled" is defined as Requiring institution of new medical or surgical treatment within one (1) month prior to study enrollment, or Requiring the re-institution of a previously discontinued medication or medical treatment within one month prior to study enrollment, or Requiring a change in medication dosage in the one month prior to study enrollment due to uncontrolled symptoms or drug toxicity (elective dosage adjustments in stable subjects are acceptable), or | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Elective Cranial Procedures With Dural Incision Pre-Operative Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered) Intra-Operative Subject's linear extent of durotomy is ≥2 cm Subject's dural margins from the edges of bony defect are ≥3 mm throughout Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an if cells are appropriately sealed (e.g. bone wax) Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an criterion) Subject has a systemic infection or evidence of any infection near planned operative site. Intra-Operative Subject has an Incidental finding that meets any pre-operative criterion listed above Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-2.917, Influenza All Subjects Healthy children 6-35 months of age (naïve cohort) or 12-35 months of age (fully primed cohort) Free of obvious health problems as established by medical history and clinical examination before entering the study Parent/legal guardian willing and capable of signing written informed consent Parent/legal guardian expected to be available for entire study Parent/legal guardian can be reached by telephone Fully Primed Cohort -Have received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study All Subjects Have known allergy to eggs or other components of the vaccine. *Refer to the Fluzone package insert for a list of vaccine components Known or suspected latex allergy Former premature infants (<32 weeks) History of bronchodilator use more than 2 times per week within 28 days of vaccination Significant underlying chronic illness (e.g., congenital heart disease, bronchopulmonary dysplasia) Immunodeficiency disease or use of immunosuppressive therapy by the participant, including perinatal exposure to or infection with human immunodeficiency virus (HIV), or known infection with hepatitis B or hepatitis C Any other condition that, in the clinical judgment of the investigator, may interfere with vaccine evaluation. Children receiving antibiotics are eligible for enrollment Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.) Previous, exposure to an investigational drug or investigational vaccine within 28 days prior to vaccination in this trial | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-40.0, Influenza Subject must have a BMI >18.5 and ≤ 28.5 kg/m2 Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose) Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in Subject must refrain from consuming alcohol for 72 hours prior to each dose Subject must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator Subject must give voluntary written informed consent to participate in this trial Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder Subject must not have an oral temperature >38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort) Subject must not suffer from an inherited or acquired immunodeficiency Subject must not suffer from a disease or be undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or non-steroidal anti-inflammatory drugs Subject must not have a serologically positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) Subject must not have a history of severe allergic reactions and/or anaphylaxis Subject must not have any arm rash or tattoos which could confound the interpretation of any injection site reactions Subject must not have participated in a previous clinical trial within 90 days prior to the first vaccination | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Immunity to Influenza Vaccine healthy aged 65+ years <65 years influenza vaccine allergy Guillain-Barre weight <110 pounds | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-30.0, Acute Lymphoblastic Leukemia Adult B Lymphoblastic Lymphoma Ann Arbor Stage I B Lymphoblastic Lymphoma Ann Arbor Stage II B Lymphoblastic Lymphoma Childhood B Acute Lymphoblastic Leukemia Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Childhood B Lymphoblastic Lymphoma Down Syndrome Hypodiploid B Acute Lymphoblastic Leukemia Philadelphia Chromosome Positive B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932 Note: B-LLy patients are not eligible for AALL08B1, and can enroll directly onto AALL0932 B-ALL patients must have an initial white blood cell count < 50,000/uL Patients must have newly diagnosed National Cancer Institute (NCI) Standard Risk B-ALL or B-LLy Murphy stages I or II; patients with Down syndrome are also eligible Note: for B-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to B-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and for immunophenotypic analysis to establish the diagnosis of B-LLy defined by the submitting institution will be accepted All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and NCI requirements for human studies must be met With the exception of steroid pretreatment (defined below) or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or B-LLy or for any cancer diagnosed prior to initiation of protocol therapy on AALL0932 Patients receiving prior steroid therapy may be eligible for AALL0932 Patients with central nervous system 3 (CNS3) leukemia CNS status must be known prior to enrollment; (Note: the CNS status must be determined based on a sample obtained prior to administration of any systemic or intrathecal chemotherapy, except for steroid pretreatment); B-LLy patients with CNS3 disease are not eligible for this protocol or the COG HR ALL protocol; it is recommended that intrathecal cytarabine be administered at the time of the diagnostic lumbar puncture; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; this is allowed prior to registration; systemic chemotherapy must begin within 72 hours of the first dose of intrathecal therapy B-ALL patients with testicular leukemia are not eligible for AALL0932 For B-LLy patients the following additional apply T-lymphoblastic lymphoma Morphologically unclassifiable lymphoma Absence of both B-cell and T-cell phenotype markers in a case submitted as lymphoblastic lymphoma | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-3.0, Child Development children aged one to three years of chronological age, of both genders, enrolled full-time, ie more than six hours in childcare elected for search children with minor changes or deviations in child development, who did at least one major meal (lunch or dinner) in the nursery, or other educational institution attended, in addition | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Healthy Volunteers Influenza NIH employees scheduled to receive the Influenza and H1N1 vaccines through OMS. 2. Health status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol. 3. Age 18 years and older (no upper limit). 4. Able to comprehend the investigational nature of the protocol and provide informed consent Recipient of another vaccine or immune modulating drug within 6 months prior to study entry. 2. Severe allergies to eggs or their products. 3. Prior severe reactions to vaccines. 4. Participation on any blood collection or blood donation procedure during study participation. 5. Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual) | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-999.0, H1N1 Virus Participants of the clinical service evaluation of novel H1N1v vaccine First or second blood sample for the clinical service evaluation successfully collected Withdrawn from clinical service evaluation of novel H1N1v vaccine Second blood sample for the clinical service evaluation not collected | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.75-50.0, Vaccination Parents of child >9 months to 25 months Child with at least one visit to one of the participating clinical sites in the previous 12 months Parental cell phone number recorded in the registration system | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Healthy Completed a medical screening questionnaire English speaking No allergies to the drugs Able to complete the forms If a woman of childbearing age, agree to use contraception History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age) Use of any medication that would contraindicate benzodiazepine administration Pregnant or nursing | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Seasonal Influenza seasonal influenza vaccine indications according to the CDC employees of partner corporations executing study none | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-75.0, Colorectal Cancer Screening Adults aged 50-75 at the time of their flu shots who are also due for colorectal cancer screening none - | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-75.0, Colorectal Cancer Participants must be primary care patients one of 6 participating clinics 2. Participants must be aged 50-75 3. Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010) None | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-999.0, Hematopoietic Stem Cell Transplant Hematologic Malignancy Patient Population HSCT recipients who are greater than 60 days post transplant Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no known disease relapse No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months Controls Age 18 to 50 years No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome No flu vaccine in previous 4 months | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Subject is 18 years of age or older on the day of inclusion Informed consent form (ICF) has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks post-vaccination Known pregnancy, or a positive urine pregnancy test Currently breastfeeding a child History of serious adverse reaction to any influenza vaccine Receipt of any vaccine in the 4 weeks preceding the trial vaccination Planned receipt of any vaccine between Visit 1 and Visit 2 Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first study vaccination or during the course of the study Receipt of any influenza vaccine since 01 August 2010 (including 2009 H1N1 monovalent vaccine) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Thrombocytopenia, bleeding disorder, or receipt of anticoagulants contraindicating intramuscular vaccination | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Cow's Milk Allergy Proved cow"s milk allergy Pregnant women | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Migraine Age 18 years or older Have had migraines for at least 3 years Have between 4 and 15 migraines a month Able to speak and read the English language Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes individuals at high risk for cardiovascular disease | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Influenza General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration Negative HIV, hepatitis B and C antibody screens Negative class A drugs, alcohol and nicotine screen Seronegative (≤10 HAI) for challenge virus Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ) History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant Venous access inadequate for phlebotomy demands Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time Subject is diabetic History or evidence of autoimmune disease or known impaired immune responsiveness Recent and/or recurrent history of autonomic dysfunction | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 25.0-999.0, Influenza Healthy individuals aged 25-40 years, or ≥65 years old. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after trivalent Influenza vaccination Receipt of immune products Receipt of blood products 3 months prior to study entry or expected receipt through 6 months after study entry Receipt of any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry* Receipt of any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry* Receipt of the 2010-2011 influenza vaccine 2. Documented influenza infection during the 2010-2011 influenza season. Not excluded from the study, volunteers with prior upper respiratory infections during the 2010-2011 influenza illness. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, auto immune diseases, severe gastrointestinal diseases, and uncontrolled hypertension Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; cancer; current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months*; receipt of high-dose inhaled steroids is also an (nasal and topical steroids are allowed.)], congenital immunodeficiency, anatomical or functional asplenia Pregnancy or breast feeding 4. Conditions that could affect the safety of the volunteers such as | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Breast Cancer Early stage breast cancer patients taking adjuvant endocrine therapy (ie, tamoxifen, anastrozole, letrozole, exemestane) Age ≥ 60 years Must have broadband internet access at home (to enable the base for the system to communicate to the Vitality server) Must have a landline or mobile phone Non-English speaking patients | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-999.0, Herpes Zoster Varicella-zoster Vaccine All Groups Must not have a fever of ≥100.4° F on the day of vaccination Any underlying chronic illness must be in stable condition History of varicella or residence in a VZV-endemic area for ≥30 years Group 1 years of age or older Took part in the Shingles Prevention Study (SPS) (V211-004, NCT00007501) and received a single dose of Zoster Vaccine, Live ≥10 years prior to enrollment in this study Group 2 years of age or older Group 3 All Groups History of hypersensitivity reaction to any vaccine component or an anaphylactic/anaphylactoid reaction to neomycin Prior history of herpes zoster Pregnant or breast-feeding, or expecting to conceive within the duration of the study Has been treated with immunoglobulin or any blood products, other than autologous (self-donated) blood transfusion, in the 5 months prior to vaccination Received any other vaccine within 4 weeks prevaccination On immunosuppressive therapy Has known or suspected immune dysfunction Is taking any non-topical antiviral therapy with activity against herpesviruses, including, but not limited to acyclovir, famciclovir, valacyclovir, and ganciclovir Groups 2, 3, and 4 | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-999.0, Egg Allergy Eligible for Vaccination Against Influenza Age > 6 months Clinical history of allergic symptoms (hives, swelling, vomiting, respiratory problems, low blood pressure) within 2 hours after ingestion of egg OR Eczema/atopic dermatitis worsened by egg exposure Confirmation of clinical history by positive egg skin prick test or serum egg-specific IgE or a positive oral food challenge. [The >95% positive predictive values of egg serum IgE in subjects >2 years old with atopic dermatitis is 6 kU/L or greater. In subjects >2 years old without atopic dermatitis, the value is 7 kU/L or greater. In subjects less than 2 years old, the value is 2 kU/L or greater.] FluMist (LAIV) cohort: Patients age 2-49 years a history of asthma symptoms or treatment within the past 12 months will receive intranasal FluMist Flu Shot (TIV) Intramuscular influenza vaccine cohort: Patients 6 months to 2 yrs or > 49 years or WITH a history of asthma symptoms / treatment within the past 12 months. History/Treatment of asthma in the past 12 months is defined as follows: 1. wheezing in the past 12 months 2. use of inhaled corticosteroids (ICS), combined ICS / long acting beta agonist (LABA), or oral steroid in the past 12 months 3. emergency room or acute care visit or hospitalization for asthma or wheezing in the past 12 months Subjects who potentially have outgrown their egg allergy (no allergic reaction with ingestion of whole egg in the past 18 months and an egg serum specific IgE level ≤2 kU/L) Pregnancy Current moderate to severe illness with a fever Allergy to other components of the vaccine gentamicin, gelatin, arginine, thimerosal or a history of a previous allergic reaction to the influenza vaccine Abnormal Vital Signs History of Guillain-Barre' Syndrome (GBS) HIV/AIDS or another disease that affects the immune system, or cancer Long term health problems that are contraindicated for the LAIV or TIV | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Hemodialysis Patients Patients under chronic hemodialysis history of flu infection in last month history of flu vaccination in 2009 hospitalization in last month taking immune suppressants drugs hemodialysis less than twice weekly | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, H1N1 Influenza Virus Influenza Rapid Test Influenza A(+) B(-) Influenza Rapid Test Influenza A(+) B(+) Influenza Rapid Test Influenza A(-) B(-) was negative control Influenza Rapid Test Influenza A(-) B(+) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Amyotrophic Lateral Sclerosis Aged 18 to 80 years old, inclusive, on Day 1 Diagnosis of sporadic or familial ALS Onset of first ALS symptoms within 24 months prior to Day 1 World Federation of Neurology El Escorial are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis Upright slow vital capacity (SVC) of 65% or more at screening Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days Must be able to swallow tablets at the time of study entry Other medically significant illness Clinically significant abnormal laboratory values Pregnant women or women breastfeeding Prior exposure to dexpramipexole Currently taking pramipexole or other dopamine agonists. Other protocol-defined inclusion/ | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Rheumatoid Arthritis Patients suffering from RA Aged 18 to 64 years old Active disease requiring a change in drug regimen Known allergy to vaccine | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Healthy years of age or older willing to complete daily and monthly questionnaires willing to receive the fall influenza vaccination as part of the study protocol willing to provide 3 blood samples, 3 saliva samples, and 2 stool samples and answer a food frequency questionnaire over the course of the study willing to discontinue any immune-enhancing dietary supplements ( e.g., prebiotics and fiber supplements, probiotics, echinacea, fish oil, vitamin E >100% of the RDA or >15 mg/day) willing to take the study fiber for 24 weeks willing to provide a social security number to receive study payment Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided had a cold in the last 12 months able to take foods and the study fiber without the aid of another person eligible and willing to receive the influenza vaccine for the current year. That is, you cannot have already received an influenza vaccine for the 2010/2011 season prior to receiving it from the study current smoker chronic allergies involving the upper respiratory tract (Chronic = taking allergy medicine daily) taking any medication for constipation or diarrhea currently taking any anti-inflammatory drugs on a regular basis currently treated for Alzheimer's disease allergy to milk or a serious allergy to eggs (note lactose intolerance should not be a problem because 1 fiber packet contains only 0.3 g of lactose whereas 1 cup of milk contains 12.8 g of lactose) currently being treated for any known illnesses or conditions that may impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune, hepatitis, cancer, etc.), diabetes, kidney disease, gastrointestinal diseases (gastric ulcers, Crohn's, ulcerative colitis, etc.) received chemotherapy or other immune suppressing therapy within the last year received antibiotic therapy in the past two months receiving supplemental oxygen | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza Male or Female, of all ages (assuming appropriate consent is obtained). 2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI). For example: 1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days. 2. Nasal congestion 3. Rhinorrhea 4. Sore throat 5. Cough 6. Headache 7. Myalgia 8. Malaise Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-55.0, Influenza Provision of signed and dated, written informed consent prior to any study-specific procedures Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements Healthy male and non-fertile female subjects aged 18 and 55 years inclusive Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential Male subjects should be willing to use barrier contraception during sexual intercourse Body weight 50 to 100 kg inclusive and body mass index (BMI) 18 to 30 kg/m2 inclusive Clinically non-significant findings on physical examination in relation to age Negative Rapid Flu Test (TRU FLU® kit) Negative nasal examination upon admission to the study center History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps Subjects with a history of sinus surgery and/or persistent hypertrophic inferior turbinates History of vaccination with live vaccine within 7 days or attenuated vaccine within 14 days of the administration of the investigational product Any clinically significant abnormalities in clinical laboratory safety assessment results A positive result at screening on serum hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies Significant orthostatic reaction at screening or upon admission to the study center as judged by the Principal Investigator | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Fasting Is the individual a healthy, normal adult man and women who volunteers to participate? Is s/he within 18 and 45 years of age, inclusive? Is his/her BMI between 19 and 30, inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Fed Is the individual a healthy, normal adult man and women who volunteers to participate? Is s/he within 18 and 45 years of age, inclusive? Is his/her BMI between 19 and 30, inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Primary Health Care Aged Clinical Information Must be greater than or equal to 65 years of age Must be patients of participating physicians Cannot speak English Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-84.0, Breast Cancer women aged 40 through 84 years old in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health plans for 18 or more months has a current Reliant Medical Group (formerly called Fallon Clinic) primary care provider has working telephone significant cognitive impairment serious illness, precluding screening bilateral mastectomy life expectancy less than 5 years | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-89.0, Tetanus healthy adult volunteers immunocompromised febrile allergy to the vaccine constituents previous tetanus immunization within 5 years medical and non-medical employees | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 8.0-13.0, Motor Activity All subjects must comply with all the following Healthy and physically active, and no diabetes or metabolism related disorders in their first degree relatives (as determined by medical and activity questionnaire) Caucasian, with English as a first language and an adequate standard of literacy BMI adjusted for age and gender which falls between the 9th and 91st as shown in the Child Growth Foundation BMI growth charts 13 years of age Having obtained his/her informed assent Having obtained his/her legal representative's informed consent Willing to allow their family doctor (GP) to be informed about their participation in this study Subjects representing one or more of the following are excluded from participation in the study Post-pubertal Taking any medication Smoker Undergoing medical treatment or investigations Body mass index > 24 Suffer from chronic diseases (with regular intake of drugs, medical history) Vegetarians Vaccination in the last 4 months Any know food allergies or intolerance | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 17.0-999.0, Pre Term Labor Multiple Pregnancy She is >=24weeks 0days but less than 36 completed weeks, with a singleton pregnancy or >=34weeks 0days with a multiple pregnancy and has been admitted to the Labor and Delivery Unit She is in the latent phase of spontaneous labor, or has been admitted for induction of labor She has given her informed consent to participate as a subject She has none of the Known major fetal malformation or chromosome abnormality Involvement in another clinical trial currently or previously in this pregnancy Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, sensitivity to adhesives) Significant medical or obstetric problem that in the investigator's opinion would make the woman incapable of taking part in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-85.0, Chronic Obstructive Pulmonary Disease COPD Age 40-85 Unable to understand English Expected life expectancy < 2 years Unable to attend hospital | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, HER-2 Positive Breast Cancer Written informed consent Females; 18 years of age or greater Histologically proven invasive breast cancer American Joint Committee on Cancer (AJCC) clinical stage IIA IIIB Tumor size greater than 10 millimeters HER2 positive Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Estrogen receptor (ER) positive or negative Ejection fraction greater than or equal to lower limit of normal for the institution by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) Fine needle cytology only without other histologic evidence of invasive breast cancer Inflammatory breast cancer AJCC clinical stage T1a-b breast cancer (primary tumor less than or equal to 10 millimeters) Evidence of metastatic disease HER2 negative Ejection fraction less than lower limit of normal for the institution by ECHO or MUGA Corrected QT interval greater than 480 milliseconds Pre-existing cardiac dysfunction Prior history of invasive cancer within the past 3 years Synchronous bilateral breast cancer | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-47.0, Rabies Willingness to provide written consent Seronegative for rabies Belgian soldiers who are deployable and visit the Travel clinic in Brussels during their preparation phase before deployment OR military students at the schools of Belgian Defense are eligible in preparation of an overseas exercise or during the scheduled vaccination program at the end of their studies Prepared to follow the study schedule Subjects who have had rabies vaccination (complete or incomplete) in the past due to post-exposure prophylaxis Subjects with a known allergy to one of the components of the vaccine Immune depressed persons or intake of immunodepressant medication Subjects who take mefloquine Planned deployment to overseas areas within 35 days | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 21.0-999.0, Breast Cancer Female Age 21 years or greater. Both pre and postmenopausal women will be included in this study. Postmenopausal status will be defined as the absence of menses for > 12 months, serum FSH > 20 mIU/ml, or history of bilateral oophrectomy Hispanic descent and fluent in Spanish History of histologically-confirmed stage 0, I, II, or III (see Appendix I for TNM staging system) invasive breast carcinoma without evidence of disease recurrent or metastatic disease at trial entry Minimum of 3 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery. Current use of hormonal therapy is permitted No uncontrolled diabetes mellitus, defined as Hgb A1C >7 No uncontrolled comorbidities (i.e., hypertension) Currently a non-smoker (rationale: women who smoke are much less likely to engage in healthy lifestyle behaviors, and it is probably more important for these women to stop smoking than it is to change their dietary patterns) Consumes <5 servings of fruits and vegetables per day, as assessed by the Block Fruit and Vegetable Screener Evidence of recurrent or metastatic breast cancer Uncontrolled diabetes (type 1 or 2), defined as Hgb A1C >7 Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia; active gastrointestinal bleeding; active liver disease; active malignancy, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ, Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, Stage Ia Grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements Previously participated in Cook For Your Life! classes Currently active in a dietary change program | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza Healthy children, adults or the elderly will be included that participated in randomized clinical trials (RCTs) and quasi-RCTs comparing influenza vaccine(s) with placebo Placebo-controlled randomized clinical trials (RCTs) reporting laboratory-confirmed influenza among healthy participants vaccinated with antigens of influenza strains that differed from those circulating All influenza vaccines will be included, and will be categorized as TIV, LAIV, and others (that is, non-TIV or non-LAIV) Only RCTs written in English will be included RCTs which are not providing any data will be excluded Studies using rapid influenza diagnostic tests will not be included, as their sensitivity is low (especially during flu season) and false positives are common during low activity seasons Laboratory-confirmed influenza through antibody assay as part of the primary outcome will not be included, as this is a less sensitive test than PCR and viral culture | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 2.0-99.0, Argininosuccinic Aciduria Carbamoyl-Phosphate Synthase I Deficiency Citrullinemia Ornithine Carbamoyltransferase Deficiency Hyperargininemia N-Acetylglutamate Synthase Deficiency Patients: Any gender and ethnicity age 2 years and older with a diagnosis of a urea cycle disorder are eligible to enroll in this protocol. Patients need to be medically and nutritionally managed by a local metabolic provider. If necessary, we will obtain written consent from the patient to review medical records from their home physician to confirm eligibility. Healthy Volunteers: Any gender and ethnicity age 2 years and older are eligible to enroll in this protocol. Have access to own personal medical provider <TAB> Less than 2 years of age Inability to travel to NIH because of their medical condition Recent (6 month) history of vaccination or immune modulating drug Severe reactions to eggs and or latex History of severe reactions to previous immunizations (e.g. hives, rash, difficulty breathing) Persons without a personal medical provider Persons with current infections or under care of medical provider for an ongoing medical issue | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-45.0, Eating Behavior Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH) to 45 years old BMI less than 40 kg/m2 Stable body weight (fluctuation of less than ± 3%) for past 3 months Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than ~100 kcal Erratic/intermittent breakfast eating Currently pregnant or lactating Shift workers/diagnosed sleep disorders Use of tobacco products Use of non-prescription drugs/hormone replacement/steroid-based medications Diagnosed endocrine, metabolic, or digestive disorder Hemoglobin <11 g/dl Plasma Glucose >120 mg/dl | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last menstrual period, ultrasound or uterine height). 2. Subject is able to understand and comply with planned study procedures. 3. Subject has provided written informed consent prior to initiation of any study procedures. 4. Subject intends to reside in the study area until her newborn infant is 6 months of age Member of a household which already has a woman who is participating or has participated in this study 2. History of severe reactions following previous immunization with influenza or meningococcal vaccines 3. History of Guillain-Barré Syndrome 4. Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra 5. Known chronic medical condition that in the judgment of the investigator could compromise the evaluation of the study vaccine or puts the subject at risk 6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 7. Any of the following complications with the ongoing pregnancy: preterm labor (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or preeclampsia. 8. Acute illness and/or an oral temperature greater than or equal to 37.8 degrees C, within 72 hours of vaccination (This may result in a temporary delay of vaccination) 9. Receipt of any other vaccine, excluding tetanus toxoid, within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines and meningococcal A conjugate vaccine (MenAfriVac)) prior to vaccination in this study 10. Woman who intends to travel out of the study area for the 40 days after delivery 11. Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines 12. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to administration of study vaccines (including systemic corticosteroids, e.g. prednisone or equivalent > 0.5 mg/kg/day; topical and inhaled steroids are allowed) 13. Any condition which in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the evaluation of the study vaccines | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Flu Employee at partner corporation Employee already received a flu shot this season | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Bacterial, Viral and Other Infectious Agents Subjects must meet all of the following to participate in the study: 1. Able to provide written informed consent. 2. Able to communicate effectively in verbal English or Spanish. 3. Willing to provide blood, saliva, urine and stool specimens from herself, and willing to provide blood, saliva, urine and stool specimens from her infant. 4. Willing to provide consent for review of Primary Provider Medical Records regarding, for the mother, medical history and infectious and other conditions during pregnancy, and for the infant, Apgar scores, height and weight measurements at birth and over time, infectious and other disease diagnoses and treatment, and vaccination records More than one fetus. 2. High risk pregnancy. 3. Intent to move from the Bay Area within three years after enrollment. 4. History of diagnosis and/or treatment, and any current diagnosis or treatment, of type 1 diabetes or of major mental illness. 5. History of diagnosis and/or treatment, and any current diagnosis or treatment, of a thyroid disorder or other endocrine condition. 6. History of diagnosis and/or treatment, and any current diagnosis or treatment that has resulted in severe immunosuppression. 7. A household member who has a compromised immune system 8. Other conditions that in the opinion of the PI would make the subject an unacceptable candidate for this study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Human Employee of Express Scripts Eligible to receive a flu shot at Express Scripts Over 18 years of age Children Non Express Scripts employees | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-12.0, Food Allergy French speaking children with confirmed IgE mediated food allergy Aged 0-12 years old in another trial Chronic severe diseases | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study? | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 5.0-999.0, Allergies Allergic Rhinitis Asthma Pediatric and adult timothy grass and Dermatophagoides farinae-sensitive subjects with allergic rhinoconjunctivitis with or without asthma perennially or during grass pollen season. 2. Subjects must be 5 years of age or older. 3. Sensitivity to the relevant allergen will be documented by a positive skin prick test result (see Appendix E for details). 4. All female subjects of child-bearing potential will be required to provide a urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study. 5. Subjects must be planning to remain in the study area during the trial. 6. Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study. 7. Subjects and/or their parents must be mentally and physically capable of self-administering oral drug No absolute contraindications to allergen skin testing and/or sublingual immunotherapy are known. However, the risk of serious systemic anaphylactic reactions to pollen or any potent allergenic extract suggests a number of preexisting conditions that should be considered relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). 1. Subjects having a history of unexplained anaphylaxis within 2 years or a history of multiple (≥2) episodes of anaphylaxis in the past year, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma. Anaphylaxis must be medically diagnosed. 2. Subjects with unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that in the mind of the investigator might interfere with the evaluation or administration of the test drug or pose additional risk to the subject e.g. gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease. 3. Subject with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with or without controller medication. 4. Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study. 5. Subjects who have received timothy grass or dust mite allergen immunotherapy within 3 years prior to admission in this study. 6. Subjects who are current users of oral, intramuscular, or intravenous corticosteroids, tricyclic antidepressants, or are taking a beta-blocker (oral or topical). 7. Subjects routinely using medication that could induce adverse gastrointestinal reactions during the study. 8. Subjects refusing to sign the EpiPen Training Form (see Appendix F). 9. Pregnant or breast feeding females. 10. Subjects who have any symptoms at dose levels 1 or 2 at the Preliminary Dosing Visit (see, below). 11. Subjects with significant pet allergies who have significant exposure at home or at work | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-17.0, Appetite • Is a healthy boy or girl between 14 and 17 years of age Is a healthy boy or girl between 4 and 6 years of age • Is suffering from any diseases such as major heart conditions, type 1 diabetes, cancer, eating disorders, or any serious illness that requires intensive and long-term medical treatment Has allergies/sensitivities/dislikes to eggs, soy, or wheat Uses drugs recreationally Is actively attempting to lose weight | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, Healthy Volunteers Healthy men and non-childbearing potential women Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m^2) Are reliable and willing to make yourself available for the duration of the study and are willing to follow study procedures and research unit policies Taking over-the-counter or prescription medication with the exception of vitamins or minerals Smoke more than 10 cigarettes per day Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per day | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Multiple Sclerosis Diagnosis of multiple sclerosis Receiving Ampyra® consistently for at least 2 weeks prior to the screening visit No history of seizures except simple febrile seizures Sexually active woman of childbearing potential who is not surgically sterile, <two years post-menopause or is not using effective birth control methods Subject who is pregnant or breastfeeding | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-65.0, Fibromyalgia In order to qualify the subject: 1. must have been diagnosed with fibromyalgia by a medical doctor 2. must be between the ages of 18 to 65 years of age 3. must have a weekly overall body pain average score ≥ 4 4. must pass a screening questionnaire that calculates a physical impairment of ≥ 10 5. must be on stable doses of his/her current medication for at least past four weeks 6. must limit any changes in his/her medication(s) (e.g., dose change, addition or discontinuation of any medication that effects the central nervous system, e.g., benzodiazepines, sedative/hypnotic, etc. ) during the 10-week study period unless medically necessary 7. must report all medication including herbal supplements and over-the-counter medications, e.g. cold medication, eye drops, etc. that he/she is currently taking to a member of the research team 8. must be willing to maintain a medication diary provided to him/her during the 10-week study period 9. must be willing to abstain (not take) any fibromyalgia related medication including over-the-counter for at least 8-hours prior to each of the two testing visits (Otherwise, he/she may take these medication(s) immediately after pain sensitivity testing has been completed and as prescribed in-between visits) 10. must agree to use a proven method of contraception to prevent pregnancy throughout this study The subject will not be allowed to participate if: 1. he/she has a history of seizures 2. he/she has atopic dermatitis (also called eczema) or chronic urticaria (hives) 3. he/she has chronic thrombocytopenia (a low blood platelet count) 4. she is currently pregnant, are planning to become pregnant, or is breastfeeding 5. he/she has been diagnosed by a psychiatrist with Schizophrenia or bipolar disorder 6. he/she has been diagnosed with another major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and/or other connective tissue diseases) 7. he/she plans to undergo an elective surgery within the study timeline 8. he/she is in the process of filing, or plan to file for disability benefits within the study timeline 9. his/her screening labs results are abnormal (i.e., elevated SGPT and low platelet count) 10. he/she is currently using any anti-allergy drugs (ophthalmic or oral histamine antagonist), leukotriene inhibitors (e.g., montelukast) or prednisone | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Healthy, no Evidence of Disease Healthy individuals seen at the Employee Health Clinic who will be eligible to receive influenza vaccine Willingness to comply with study expectations subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure ONLY Willing to suspend use of any other vitamin D supplementation during the 3 month treatment interval; if currently using > 2,000 IU/day of vitamin D supplementation, must suspend use 30 days prior to enrollment -not RPCI employee | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Breech Presentation at Term singleton breech presentation gestation age above 36 weeks + 6 days multiples cannot understand German language | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Mucositis Patient has oral mucositis pain that is grade 3 or 4 according to the World Health Organization (WHO) Oral Mucositis Scale Patient has received at least one prior chemotherapy or radiation treatment Patient is at least 18 years old Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.25-0.417, Meningitis Influenza Healthy subjects aged 3 to 5 months, normal intelligence The subjects' guardians are able to understand and sign the informed consent Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature<=37°C on axillary setting for the first vaccination Subject who has a medical history of Meningitis Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws Any acute infections in last 7 days | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 5.0-18.0, Sleep Burns 18 years old anoxic brain injury preexisting neurological disorder pre-existing sleep disorder no informed consent or HIPAA release | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 10.0-12.0, Child Healthy and physically active (as determined by medical and activity questionnaire) 12 years of age Within approximately 2 years of estimated age of peak height velocity (PHV) Minimum aerobic fitness of 35 ml/kg/min as assessed by the McMaster All-out Progressive Continuous Cycling Protocol Having obtained his/her informed assent Having obtained his/her legal representative's informed consent Post-pubertal Taking any medication Smoker Undergoing medical treatment or investigations Body mass index > 24 Suffer from chronic diseases (with regular intake of drugs, medical history) Vegetarians Vaccination in the last 4 months Any know food allergies or intolerance Pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, HIV Dementia Men and women 18 years of age or older and less than 65 years of age. Able to read and understand English. HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study. Significant dementia but able to give consent (International HIV Dementia Scale score <10). Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test. Beck Depression Inventory score <16. Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit. Baseline CBC and chemistry panel Grade 1 or normal. For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry. NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia. All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. Ability and willingness of subject to provide informed consent Inability to give informed consent. No proxy consent allowed. Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline). Untreated hypogonadism, hypothyroidism or hyperthyroidism. Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit. Pregnancy or breast feeding. Clinically significant EKG abnormalities at screening. History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia. Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis. History of epilepsy. Untreated depression. Uncontrolled diabetes (glucose <70 or >200 at screening). Use of interferon or ribavirin during study and for 1 month prior to screening. History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related. History of schizophrenia, mania or other serious mental illness. History of methylphenidate allergy. Other serious concurrent medical illness other than HIV. History of radiation therapy to the brain or brain injury. History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study. Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit. Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study. History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit. If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study. Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study. History of tic disorders in the past 3 months or any history of Tourette's syndrome. Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height) Uncontrolled migraine headaches. History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis. Family history of sudden cardiac death in a young relative. History of fainting with exercise. History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale. - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-80.0, Allergies Twin participants ages 0 to 80 years who are with or without allergy disease Patients with special risks attendant to venipuncture will be excluded | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-65.0, Smoking Healthy female smokers ages 18 Read and write English Regularly smoke 5 or more cigarettes a day Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week known history of cardiovascular pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension Pregnant or planning to become pregnant within the next 12 months Women hospitalized for a psychiatric disorder Receiving treatment for bipolar disorder or schizophrenia Current alcohol abuse or psychological problems when quitting in the past that required treatment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-75.0, Infection Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division Patients with SIRS (systemic inflammatory response syndrome) Intravenous vancomycin therapy deemed necessary Age less than 20 years Age more than 75 years Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation History of adverse events to vancomycin 5. Pregnant woman | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol A male or female 18 years of age and older at the time of the first vaccination Written informed consent obtained from the subject Healthy subjects as established by medical history and clinical examination before entering into the study Female subjects of non-childbearing potential may be enrolled in the study Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period Administration of any influenza vaccine within 6 months preceding the study start or planned use of such vaccines during the study period Administration of any other vaccine(s) within 30 days prior to study enrolment or during the study period Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination Acute disease and/or fever at the time of enrolment Significant acute or chronic, uncontrolled medical or psychiatric or neurological illness Any confirmed or suspected immunosuppressive or immunodeficient condition Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests Insulin-dependent diabetes mellitus Presence of blood dyscrasias, including hemoglobinopathies and myelo | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Chronic Kidney Disease End Stage Renal Disease Anemia Minimum age 18 years 2. Completed the Treatment Period of an ongoing FG-4592 FibroGen-sponsored anemia study in the U.S Subjects assigned to epoetin alfa in a previous ongoing FG-4592 anemia study 2. Pregnant or breastfeeding females 3. Females of childbearing potential, unless using contraception as detailed in the protocol; male subjects with sexual partners of childbearing potential who are not on birth control unless the male subject agrees to use contraception 4. Subjects who received FG-4592 in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment 5. Any medical condition that in the opinion of the investigator may pose a safety risk to a subject in this study, or which may interfere with study participation | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Eosinophilic Esophagitis Food Allergies Male and female subjects 18 years and older 2. Previous diagnosis of eosinophilic esophagitis with clinical symptoms including heartburn, dysphagia, vomiting, epigastric pain, recurrent vomiting, food impaction as well > 15 eosinophils per high powered field (400x magnification) by endoscopic esophageal biopsy in both the proximal and distal esophagus 3. Previous diagnosis of gastroesophageal reflux with < 15 eosinophils per high powered field (400x magnification) by endoscopic biopsy Male and female subjects less than 18 years of age 2. Pregnant female subjects 3. Subjects who are receiving systemic steroids and are unable to stop prior to enrollment 4. Subjects who are receiving systemic antihistamines and are unable to stop prior to enrollment 5. Subjects who are unable to cooperate/comply with study procedures or communicate with investigator in order to successfully complete the study 6. Subjects with severe skin disorders such as atopic dermatitis, dermatographism, or psoriasis who would be unable to complete skin or patch testing 7. Subjects with an infirmity, disability, or geographical location which seems likely to prevent regular attendance for patient visit - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Sickle Cell Diabetes Cancer Cardiovascular Disease Genetic Screening Aged 18 years or older Ability to complete in-person, web-based or telephone survey/interview(s) Ability to read English or Spanish (in some cases) Affected by or have at least one first or second-degree relative affected by or have a spouse/partner affected by the disease(s) of interest OR Biological or non-biological (e.g. adopted or step) relative of the primary participant or spouse/partner of the primary participant or biological relative of primary participant Individuals with cognitive difficulties will be excluded from the study, as participants will be required to comprehend and legally consent to participation in this study and complete the survey/interview(s) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.417-1.417, Malaria Healthy infant/child aged 5-17 months at the time of first study vaccination 2. Informed consent of parent/guardian 3. Infant / child and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up Clinically significant skin disorder (psoriasis, contact dermatitis etc.), immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness Weight-for-age Z score of less than -3 or other clinical signs of malnutrition History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunisation History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, beta-propiolactone Haemoglobin less than 8.0 g/dL, where judged to be clinically significant in the opinion of the investigator Serum Creatinine concentration greater than 70 µmol/L, where judged to be clinically significant in the opinion of the investigator Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator Blood transfusion within one month of enrolment Previous vaccination with experimental malaria vaccines Administration of any other vaccine or immunoglobulin less than one week before vaccination with any study vaccine | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-60.0, Enhancement of Protective Antibody Response After Probiotic Consumption healthy male and female adult between 18 and 60 years old non menopausal female( with effective contraception) female non pregnant not wishing to be pregnat during the study capable to respect the protocol affialted to the social security system aggreeing to be registered in the national fileof volunteers food allergy( component of the experimental product vaccines) manifestation of allergy vaccinated against flu during the 2 previous winters Food allergy, allergy to one of the component of the experimental products or allergy to one of the component of the flu vaccine Subject displaying manifestation of allergy or being treated for these Subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and winter 2010-2011) Subject who had symptoms evocating flu during the previous winter (winter 2010-2011) Subject immunodepressed Subject with immunomodulatory treatment | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Influenza Residents of one of the participating LTC sites years or older at the time of consent require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff Age less than 65 years Life expectancy less than 6 months History of allergic reaction to influenza vaccine, its components, or eggs History of severe allergic reaction to latex History of Guillian-Barre Syndrome Actively undergoing chemotherapy Actively undergoing radiation therapy Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days Serious current immunosuppression or immunosuppression expected in the next 6 weeks Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 30.0-69.0, Acute Respiratory Infection Aged 30-69 years at study entry Must answer "Yes" to either "Have you had at least 2 colds in the last 12 months?" and/or "On average do you get at least 1 cold per year?" Prospective participants must meet the American Heart Association guidelines for suitability for an exercise program. Prospective participants will be advised (but not required) to seek their physicians' advice before enrollment Self-reported ability and willingness to follow through with either exercise or meditation training, or neither, according to randomized allocation, and to participate in blood draws, nasal wash, self-report questionnaires, and weekly monitoring for 9 months A score of 14 or lower on the PHQ-9 depression screen, self-reported both at entrance to run-in trial and again just prior to enrollment in the main study Fluency and literacy in English language sufficient for understanding the study protocol and completing questionnaires Successful completion of tasks during run-in period, including 2 in-person appointments, 1 phone contact, 1 set of homework questionnaires, and baseline nasal wash and blood draw Current or recent use of meditative practice, or previous meditation training. Assessed by answering "Yes" to any of the following questions: Do you meditate on a regular basis? In the last year, have you meditated at least weekly for 2 or more months in a row? Have you ever been trained in meditation? Have you ever been involved in a mindfulness class or mindfulness practice? Potential participants must not engage in moderate exercise more than twice per week or vigorous exercise more than once per week, as assessed by the following questions adapted from the Behavioral Risk Factor Surveillance System (BRFSS) classification system: On average, how many times per week do you engage in moderate recreational activities such as walking, tennis doubles, ballroom dancing, weight training, or similar activities that last at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 times per week; E) >4 times per week. How many times per week do you engage in vigorous sport and recreational activities such as jogging, swimming, cycling, singles tennis, aerobic dance or other similar activities lasting at least 20 minutes per occasion? A) Less than 1 time per week; B) 1 time per week; C) 2 times per week; D) 3 or more times per week Women who are pregnant at screening or plan to become pregnant during the course of the study (determined by self-report) will be excluded. Women who become pregnant any time during the course of the trial will not be dropped and will continue to be followed throughout the duration of the study Physical, medical or mental condition(s) precluding adherence to study protocol. Conditions malignant disease (prospective participants' physicians to advise and Dr. Barrett, and/or designee Dr. Rakel or Dr. Muller, to make final decision); and function-impairing psychopathology (prospective participants' psychiatrist or psychologist to advise). Questionable cases will be reviewed by the study physicians True contraindication for influenza vaccine (flu shots) or refusal to accept influenza vaccine. Subjects will be asked to verify they have a) no known egg allergy, b) no prior reaction to influenza vaccine, and c) never been told they have Guillain-Barre Syndrome Current use or forecasted need for immunoactive drugs (eg. steroids, immunosuppressants, chemotherapy); nonsteroidal antiinflammatories will be allowed Immune deficiency or auto-immune disease (eg. HIV/AIDS, lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease). Questionable cases will be reviewed by study physicians | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-999.0, Influenza participants were enrolled (toddlers: 6 months to 3 years; school-aged children: 6 to 12 years and older adults: ≥60 years） Eligible participants were generally healthy or had stable chronic medical conditions (for older adults only) History of allergic reaction to any component of the study vaccines or previous influenza vaccine History of systemic hypersensitivity to hens' eggs History of Guillain Barré syndrome following administration of any influenza vaccine Any immunodeficient or immunocompromised conditions Receipt of cytotoxic or immunosuppressive drugs within the past 6 months Receipt of blood-derived product within the past 3 months Receipt of any vaccine within one month prior to study entry with exception of paediatric routine vaccination Receipt of non-study 2010-2011 seasonal TIV Participation in any other study with a non-approved drug during the study Acute febrile disease and other self-limiting illness were the temporary | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Parent Attitudes Parents of dehydrated children aged 0-18 Child with severe dehydration Child with chronic disease causing dehydration | 0 |
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