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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Influenza Influenza Vaccines Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study A male or female between, and including, 18 and 60 years of age 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 If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to first vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study History of vaccination with investigational influenza pandemic vaccine History of administration of an experimental/licensed vaccine Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51; from 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6 and Month 12; from Month 6 up to Month 6 + 30 days; from Month 12 up to Month 12 + 30 days Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination History of hypersensitivity to vaccines History of allergic disease or reactions likely to be exacerbated by any component of the vaccine History of chronic alcohol consumption and/or drug abuse Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Influenza Influenza Vaccines Subjects who the investigator believes that they can and will comply with the requirements of the protocol A male or female between, and including, 18 and 60 years of age 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 If the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series Administration of any licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study Planned administration of a vaccine not foreseen by the study protocol during the following periods: from Day 0 up to Day 51, 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Month 6; from Month 6 up to Month 6 + 30 days (or Month 6 + 51 days for the control groups) Previous vaccination with a pandemic candidate vaccine or a vaccine containing the same adjuvant as the study vaccine Previous proven contact with H5N1 wild type virus (i.e. contact with an individual with laboratory-confirmed H5N1 infection, or contact with an animal (e.g. poultry) which died as a result of H5N1 infection) Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the candidate vaccines Any confirmed or suspected immunosuppressive or immunodeficient condition, or autoimmune diseases such as Guillain Barre Syndrome, based on medical history and physical examination (no laboratory testing required) History of hypersensitivity to vaccines History of allergic disease or reactions likely to be exacerbated by any component of the vaccine History of chronic alcohol consumption and/or drug abuse Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Recurrent Lymphoepithelioma of the Nasopharynx Recurrent Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx Histologically or cytologically confirmed nasopharyngeal carcinoma, meeting the following World Health Organization (WHO) type II-III disease Stage IV or recurrent disease Must have failed at least 1 prior line of chemotherapy for metastatic or recurrent disease Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan No known brain metastases Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 or Karnofsky PS 70-100% Life expectancy > 3 months WBC >= 3,000/mm³ Absolute neutrophil count >= 1,500/mm³
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Von Willebrand's Disorder Healthy Must be female Aged 18 to 50 years, with regular menstrual cycles Healthy volunteers and women with von Willebrand's disorder are both being recruited Pregnancy Use of hormonal therapy including birth control pills Use of hemostatic agents such as DDAVP or anti-platelet agents
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-70.0, Primary Operable Breast Cancer Women that are scheduled to undergo surgery of a single, stage I-III, invasive ductal or lobular carcinoma tumor with curative intent No evidence of metastatic disease prior to surgery. Minimal workup would chest XR, abdominal ultrasound and bone scan Age between 20 and 70 year old ASA score of 1-2 The patient is able to understand the study objectives and procedures, able to comply with the protocol, and is capable to sign an informed consent Patients with metastatic disease, known prior to surgery Patients in whom surgical resection is planned without curative intent Patients who have undergone neoadjuvant treatment Patients with renal failure, measured by creatinine level >1.5 Patients with significant heart failure (NYHA functional class 3 or higher) Patients with significant liver failure (known cirrhosis, Bilirubin level>2) Patients suffering from asthma Patients with known allergy to one or more of the study medications Patients with known allergy to any medication from the non-steroidal anti-inflammatory drug group Patients with diabetes mellitus (type 1 or 2)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Premenstrual Dysphoric Disorder PMDD diagnostic and severity 1. Women with PMDD according to DSM-IV-TR At screening by history At the end of the Qualification Phase by review of symptom records. 2. The first 2 consecutive or 2 out of 3 consecutive qualification cycles must fulfill the following For women who were not on any medications for the PMDD symptoms Late luteal phase (7 days which the last six days before menses through day one) daily average of > or equal 3.5 for at least 4 of 7 of these days on any 5 distinct items with no overlap on Daily Record of Severity of Problems (DRSP) Scale, at least one item must represent a non-physical symptom. Entries in the diary must be present for at least three of these days for the item to be used as an criterion for that month Follicular phase (days 8-12 after first day of menses) daily average less than or equal 2.5 on DRSP scale for non-physical symptoms only. The average will be calculated for days 8-12 of the cycle, day 1 being the first day of menstrual bleeding. Entries in the diary must be present for at least three of these days for the item to be used as an criterion for that month Late luteal phase (6 days before menses through day 1) daily average at least twice as high as follicular phase daily average for five distinct items Functional impairment questions for late luteal phase require more than or equal to 4 score on at least one item for at least 2 or more days For women who were on anti-depressants or oral contraceptive for at least 2 months Late luteal phase daily average of 2.5 or more for at least 4 of 7 of these days on any 5 distinct items with no overlap on DRSP-scale, at least one item must represent a non-physical symptom. Entries in the diary must be present for at least three of these days for the item to be used as an criterion for that month Women, who are pregnant, gave birth within the last 8 months, breast-feeding or intending to become pregnant within 6 months. 2. Contraindication or hypersensitivity to levetiracetam. 3. Ongoing psychotherapy, which has begun <3months prior to the study visit. 4. Participation in another clinical trial within the last 3 months prior to the screening visit. 5. Known hypersensitivity to Levetiracetam 6. Any disease or condition that can compromise the function of body systems and which could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication. 7. Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results. 8. Uncontrolled thyroid problems. 9. Active use of substances, excluding caffeine and nicotine, will not be permitted during the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Aphthous Stomatitis Patients willing and able to provide written informed consent for the study Patients with a history of at least three episodes of minor recurrent aphthous stomatitis (RAS) within the past one year Patients with a history of other forms of RAS (major, herpetiform) Patients who will be using any other vitamins/supplements during the study or those who have used any vitamins/supplements on a regular basis during the 90 days immediately preceding enrollment onto the study (regular use is defined as continuous daily use for at least a two week period) Patients who are under the age of 18 Women who are pregnant or nursing or those who plan to become pregnant Patients with a history of gout, kidney stones or iron overload disease Patients who currently smoke tobacco products Patients who are former smokers who have quit smoking within the past 30 days Patients with sulfite allergy Patients with a history of any systemic condition associated with oral ulceration. These Behcet's syndrome, Sweet's syndrome, Celiac disease, Crohn's disease, ulcerative colitis, HIV infection/AIDS, cyclic neutropenia and PFAPA syndrome (periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis) Patients on medications commonly associated with causing oral ulceration. These nicorandil, methotrexate and chemotherapeutic agents used for cancer
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Influenza Influenza, Human A male or female aged 18-60 years old at the time of vaccination, who previously participated in 108656 clinical trial Subjects who the investigator believes that they can and will comply with the requirements of the protocol Written informed consent obtained from the subject Free of obvious health problems as established by medical history and clinical examination before entering into the study If the subject is female, she must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the administration of the study vaccine, or planned use during the study period Planned administration of an influenza vaccine other than the study vaccines during the entire study period Previous vaccination against influenza since January 2007 Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Administration of immunoglobulins and/or any blood products within three months preceding the dose of study vaccine or planned administration during the study period History of hypersensitivity to a previous dose of influenza vaccine History of confirmed influenza infection within the last 12 months Pregnancy
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-40.0, Influenza Male or non-pregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 40 years, inclusive Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to 1 year) who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, intrauterine devices, and licensed hormonal methods) for the entire study period Is in good health, as determined by vital signs (heart rate < 100 beats per minute, blood pressure: systolic less than or equal to 140 mm Hg and greater than or equal to 90 mm Hg, diastolic less than or equal to 90 mm Hg; oral temperature < 100 degrees Fahrenheit), medical history to ensure stable* medical condition and a targeted physical examination based on medical history. (*A stable medical condition is defined as no recent change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company, etc, or is done for financial reasons, as long as in the same class of medication, will not be considered a violation of the criterion. Any change to prescription medication due to improvement of a disease outcome will not be considered a violation of the criterion.) Able to understand and comply with planned study procedures Provide informed consent prior to initiation of any study procedures and are available for all study visits Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, aluminum hydroxide, and chicken protein) Have a positive urine or serum pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding Have immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy Have long-term use of oral steroids, parenteral steroids, or high-dose inhaled steroids (>800 micrograms/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed.) Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study Have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. (This includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients) Have a history of severe reactions following immunization with contemporary influenza virus vaccines Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 1 week of vaccination
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 13.0-999.0, Tonsillitis Pharyngitis Patients selected among the cases referred to tonsillectomy for recurrent pharyngitis episodes to a tertiary care university ENT clinic (Oulu, Finland) At least three pharyngitis episodes difficult enough for the patients to seek for medical attention during the past 12 months Patients with other serious diseases (day surgery not feasible) Patients having long time antibiotic treatment for other disease Patients diagnosed to have peritonsillar abscess Pregnancy Age of 12 or under Patients living outside Oulu or its 8 neighbouring cities (day surgery not feasible) Patients suffering only from halitosis or bacterial plugs of palatine tonsils
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-40.0, Depression Pregnant woman between 18 and 40 years of age Have depression as their only mental health disorder Have been receiving fluoxetine or citalopram for the treatment of depression for at least one month on the day of study entry for patients in the fluoxetine and citalopram arms, or no pharmacological treatment for patients in the control arm ≤ 26 weeks pregnant by estimated date of confinement Ability to give informed consent Singleton pregnancy Pregnant women no history of depression Having any comorbid mental disorder other than generalized anxiety disorder as a secondary disorder History of or current epilepsy, endocrine, cardiac, pulmonary, renal or hepatic dysfunction that could negatively influence pregnancy and/or neonatal outcome Abusing alcohol or drugs Use of any self prescribed herbal treatments for depression
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 25.0-40.0, Human Papillomavirus (HPV) Vaccine Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for vaccination visits and for the follow-up visit) should be enrolled in the study. • The female subject should be married of Vietnamese origin, residing in Vietnam, and between, and including, 25 to 40 years of age at the time of the first vaccination Written informed consent obtained from the subject (prior to enrolment) Healthy subjects as established by medical history and clinical examination before entering into the study Subjects must have a negative urine pregnancy test Subjects of childbearing potential (i.e. active menstrual cycle) at the time of study entry must not be pregnant and must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period and up to one month after the last vaccine dose Subjects who have delivered recently or breastfeeding women must have completed a period of at least 3 months post-pregnancy and should not be breast-feeding in order to be enrolled in the study. Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs on 14 consecutive days within six months prior to the first vaccine dose and up to one month after the last dose of the vaccine. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed) Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before (Days and 30 days (i.e. Days 0 after the first dose of vaccine. However, the administration of tetanus toxoid vaccine up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period Any medically diagnosed or suspected immunodeficient condition such as human immunodeficiency virus (HIV) infection based on medical history and physical examination (no laboratory testing required) History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines, e.g. AS04, aluminium, MPL Hypersensitivity to latex (found in syringe-tip cap and plunger)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 40.0-60.0, Heart Disease Healthy Females 60 years of age
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Tonsillitis Age at least 18 years Indication for tonsillectomy (patients undergoing a tonsillectomy as a portion of additional surgical procedures will not be included) Have the ability to understand and the willingness to sign a written informed consent document History of bleeding disorders History of liver or kidney dysfunction History of allergy to sulfa containing medications History of lactose intolerance History of asthma, urticaria, or allergic-type reactions to aspirin or NSAIDs Women who are currently pregnant, nursing, or trying to conceive History of allergy or intolerance to acetaminophen or hydrocodone History of allergy to any COX-2 inhibitor, including celecoxib or rofecoxib PT, PTT, hemoglobin, or hematocrit values that are outside of institutional limits History of cardiovascular disease
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-75.0, Healthy Be a cooperative, healthy male or female between the ages of 18-75 inclusive. 2. Have a physical examination which reveals no clinically significant abnormalities at the screening visit. 3. Have fewer than 6 gastric or duodenal erosions visible on nasal endoscopy at Visit 2. 4. If the subject is female and of childbearing potential, she has been using effective contraception since the last date of her menses, will continue to use effective contraception during the study period, is not breast-feeding or lactating at screening and has had a negative urine pregnancy test at screening. Women who have been post-menopausal for less than 2 years will also require a urine pregnancy test at screening. 5. Have provided written informed consent prior for admission to this study. 6. H. pylori negative serologic exam prior to baseline nasal EGD Active GI disease (e.g. IBD), or a history of GI ulcers or bleeding 2. History of gastric or intestinal surgery 3. Use of ASA, NSAIDs, coxibs, or acetaminophen at any dose within 2 weeks prior to the randomization visit of the study. 4. Positive FOBT at baseline. 5. Use of over-the-counter or prescription: sucralfate, antacids, H2-receptor antagonists, misoprostol, or proton pump inhibitors 4 weeks prior to enrollment and/or during the study 6. A known allergy to the topical anesthetic, lidocaine
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Chronic Lymphocytic Leukemia Untreated stage A CLL patients Healthy volunteers Patients with other malignancies Patients receiving corticosteroids or other immunosuppressive drugs Patients who have received vaccination against influenza in the past 6 months Patients who have had an allergic reaction to a flu shot in the past, or have an allergy to eggs or who previously developed Guillain-Barré syndrome within 6 weeks of getting a flu shot Patients failing to give informed consent Patients using homeopathic remedies such as echniaea cream
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-1.0, Childhood Immunization Completion Childhood Immunization Dropout Immunization Card Center Based Education All children visiting the selected EPI centers for DPT1 immunization Not residing in the same area for last six months
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza A male or female 18 years of age or greater at the time of the first vaccination Written informed consent obtained from the subject Among 18 to 49 year old subjects, good general health as established by medical history and clinical examination before entering into the study Among subjects > 49 years of age, stable health status within 1 month prior to enrollment Access to a consistent means of telephone contact Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits Evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subjectunable/unlikely to provide accurate safety reports Diagnosed with cancer, or treatment for cancer, within 3 years An oral temperature ≥37.8º C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus infection Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin Administration of any vaccines within 30 days before study enrollment Previous administration of any H5N1 vaccine Use of any investigational or non-registered product or planned participation in another investigational study within 30 days prior to study enrollment, or during the 364 days following the first test article dose. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Ocular Melanoma Patients must have uveal melanoma for which enucleation is indicated, usually lesions greater than 8 mm in diameter and greater than 2 mm in thickness Patients should have no evidence of metastatic disease as determined by history, physical examination, and appropriate liver injury enzymes Patients should have received no prior interferon Age >18 years. Because of limited data on the use of pegylated interferon in patients <18 years of age and uncertainties about possible differences in NK response, children are excluded from this study. Since ocular melanoma is rare in children this is not expected to be an issue Life expectancy of greater than 3 months ECOG performance status of 0 (Karnofsky 60% or better; see Appendix II) Patients must have normal organ and marrow function as defined below Hgb >/= 12.5 g/dl or hematocrit >/= 38% Leukocytes >3,000/mcL Patients who have had agents known to be immunosuppressive (e.g, glucocorticoids) within the 4 weeks prior to planned receipt of study drug Patients receiving any other investigational agents Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study because interferon alpha has the potential for teratogenic effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with interferon, breastfeeding should be discontinued if the mother is treated with this agent HIV-positive patients are ineligible because of the known immunosuppression associated with this disease Patients with history of other malignancies are eligible provided that they are clinically free of metastases at the time of the study Patients who have donated blood in the 56 days prior to the 500cc blood draw in this study are not eligible
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Tonsillitis Obstructive Sleep Apnea Patient planned for tonsillectomy for indications of chronic tonsillitis or obstructive sleep apnea Written informed consent form is given from patient or patient's parents (in case of pediatric patient) Pregnancy History of bleeding disorders Unilateral tonsillectomy Much difference in size of both tonsils (if the difference is more than or equal to 2, it will be defined as much different in size in this study) Patient unable to understand evaluation method Patient unable to be contacted via telephone
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Influenza Male and Female of all age groups Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination Must be able to collect sample using the nasal swab sample type Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-25.0, Infections, Papillomavirus Papillomavirus Vaccines Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study A female between, and including, 20 and 25 years of age at the time of the first vaccination Written informed consent obtained from the subject Healthy subjects as established by medical history and history directed clinical examination before entering into the study Subjects must not be pregnant Subjects must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after each dose of vaccine. Administration of routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of study vaccine is allowed Concurrently participating in another clinical study, at any time during the study period (up to Month 13), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device) A subject planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose Pregnant or breastfeeding women Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period Previous administration of components of the investigational vaccine Previous vaccination against hepatitis B or planned administration of any hepatitis B vaccine other than that foreseen by the study protocol during the study period History of hepatitis B infection
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 35.0-90.0, Breast Neoplasms Ultrasonography be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer have had no screening mammogram in the past 10 months agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed agree to have a screening mammogram in approximately one year agree to answer follow up question in approximately one year meet the usual for breast screening (be asymptomatic of focal breast disease) have no history of breast cancer for at least one year agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy greater than 7 cm compressed breast thickness at mammography
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, To Determine the Bioavailability of Tranylcypromine Subjects will be normal, healthy adult men and women who volunteer to participate Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has 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 taht the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to tranylcypromine? Does/ s/he have clinically significant laboratory abnormalities that would interface 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, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface 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 saliva alcohol 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 alst blood sample has been taken? Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two? Has s/he used any prescription drug 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 during the study?
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-35.0, Contraceptive, Oral, Hormonal Healthy female volunteers Age: 18 years (inclusive), smokers must not be older than 30 years at History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days) Willingness to use barrier methods of contraception (condoms with spermicide, diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during the trial Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation) Obesity (BMI > 30.0 kg/m2) Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit 1 or a normal result has to be documented within the last 6 months before Visit 1) Laboratory values outside range at Screening Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g Cardiovascular - presence or a history of venous or arterial thrombotic/thromboembolic events (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g., transient ischemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, e.g., a family history indicating a hereditary predisposition. - uncontrolled arterial hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg) Liver - presence or history of liver tumor (benign or malignant) -
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Conjunctivitis, Allergic At least 18 years of age & either sex, any race Willing and able to follow all instructions and attend all study visits Positive history of ocular allergies Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge Have planned surgery during trial period Female currently pregnant, planning a pregnancy, or lactating Use of disallowed medications
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Anovulation Hyperandrogenism Polycystic Ovary Syndrome Single Nucleotide Polymorphism A clinical and laboratory diagnosis of the polycystic ovary syndrome (cases). Female family members of index cases, up to a great grandmother and fathers of index cases None
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-0.077, Premature Birth Mother and Father, if named on the birth certificate application, are English speaking If mother and Father are married, husband is the man identified as the father on the birth certificate application Documentation of Informed Consent for Mother and newborn. Father named on the birth certificate application must consent for newborn to participate Mother's age (and Father if named on the birth certificate application) is 18 years of age or older Infant is a singleton, inborn newborn Newborn gestational age assessment documented in the health record between 23 weeks 0/7 days and 36 weeks 6/7 days Newborn gestational age assessment documented in the health record > 37 weeks and 0/7 days Mother identifies herself as Black or African American on the birth certificate application Mother (or Father identified on the birth certificate application) refuses to sign informed consent Mother (or Father identified on the birth certificate application) does not speak English Father, identified on the birth certificate application, objects to infant's participation Husband is not the father named on the birth certificate application Mother (or Father, if named on the birth certificate application) is less than 18 years of age Mother fails to identify her ethnic group as Black or African American on the birth certificate application Mother is cognitively impaired as a result of receiving narcotic analgesia within four hours of the time the research is explained, consent explained, or the interview is conducted Mother is documented to be cognitively impaired by her physician in the medical record Father appears to be cognitively impaired at the time the research is explained, consent explained, or the interview is conducted Mother or infant has a history of blood transfusion in the last six months
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Advanced Cancer Patient with advanced cancer (local recurrence or metastatic) at the time of their follow up visit to the outpatient palliative care clinic or at an agreed date after the first visit to the outpatient palliative care clinic. 2. Patient designates a family member who is a patient's parent, spouse, adult child, sibling, other relative, or significant other (any other person defined by the patient as a partner) to answer the family questionnaire. 3. Patient is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population). 4. Patient with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process. 5. Patient willing to participate in the study and sign informed consent. 6. Family member is 18 years of age or older (as the assessment tools used in this study have not been validated in the pediatric population). 7. Family member with normal cognitive status as determined by the interviewer and by her/his ability to understand the nature of the study and consent process. 8. Family member willing to participate in the study and sign informed consent. 9. All participants in the international centers must be from Argentinian, Chilean, or Guatemalan descendence respectively. 10. All participants in the U.S. must be from self-reported Hispanic descendence, first or second generation immigrants, and reside in the U.S. for at least 5 years Either patient or family member can not complete the assessments independently. 2. Either patient or family member refuses to participate in the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-42.0, Gestational Diabetes Mellitus 42 years of age at 20-30 weeks of gestation Caucasian or African-American and non-users of medications known to influence carbohydrate metabolism <18 years or >42 years of age non-Caucasian or non-African-American ethnicity use of drugs that could interfere with glucose or insulin metabolism; or health problems such as diabetes mellitus or liver, heart, lung and kidney diseases
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Influenza A male or female 18-64 years old at the time of the first vaccination Written informed consent obtained from the subject Good general health as established by medical history and clinical examination before entering into the study Access to a consistent means of telephone contact Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of short and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Diagnosed with cancer, or treatment for cancer, within 3 years Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may be enrolled, but other histological types of skin cancer are exclusionary Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may be enrolled Presence of an oral temperature ≥37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection Receipt of systemic glucocorticoids within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin Administration of any vaccines within 30 days before study enrollment or during the 30 days following the last test article dose. Subjects who receive such immunizations on an emergent basis after enrollment will be followed per protocol and included in the Total Vaccinated Cohort (TVC), but excluded from the According to Protocol (ATP) Cohort for both safety and immunogenicity
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-60.0, Obesity Diabetes Diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive Body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group) Not involved in regular physical activity (more than 3 times per week) Women must have regular menstrual cycles (1 menstrual bleeding each month) For men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches) You smoke You have liver, kidney, thyroid or heart diseases, or cancer You are claustrophobic You have metal objects in your body such as implanted rods or surgical clips If you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism If you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.) If you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded) If you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month) You have previously had a BMI >35 kg/m2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Multiple Sclerosis Myasthenia Gravis Transverse Myelitis years or older Diagnosis of multiple sclerosis, myasthenia gravis, or other autoimmune or inflammatory neurological disease inability to give informed consent
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza A male or female 18 years of age or older at the time of the first vaccination Written informed consent obtained from the subject Stable health status as defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits Subjects who the investigator believes can and will comply with the requirements of the protocol Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Diagnosed with cancer, or treatment for cancer, within 3 years Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enroll within 3 years of diagnosis, but other histologic types of skin cancer require a 3 year untreated and disease-free window as above Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic tamoxifen are excepted and may enroll Presence of an oral temperature ≥ 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin Administration of any vaccines within 30 days before the first study vaccine dose
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 4.0-999.0, Food Allergies Chronic, reproducible symptoms following meals. 2. Multiple food allergies where dietary avoidance is nearly impossible. 3. Patients age 4 and older. 4. Testing to verify food allergies is positive History of anaphylaxis, angioedema, asthma, or life-endangering reactions to certain food products. 2. Children under the age of 4. 3. Previous attempts to treat food allergy (subcutaneous injections). 4. General medical condition that precludes elective therapy (including pregnancy). 5. Inability to follow food allergy SLIT regimen. 6. Autoimmune Disease. 7. Chronic use of steroids
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Postoperative Nausea and Vomiting All of the following must be met for the potential subject to be eligible for participation: 1. The subject is a female scheduled to undergo ambulatory breast surgery performed under general anesthesia 2. The subject is expected to undergo general inhalation anesthesia. 3. The subject presents with two of the three following high-risk factors associated with PONV (must be in their medical history in order to be eligible) She is a non-smoker She has documented history of PONV and/or motion sickness She is expected to receive intra-operative and postoperative opioid. 4. The subject's American Society of Anesthesiologist physical status is ASA I-III 5. The subject is between18 to 65 years of age. 6. The subject is expected to be discharged from the hospital/surgical center on the same day as the surgery. 7. The subject has provided written informed consent to participate in the study. If any of the following are met, the potential subject is NOT eligible for participation: 1. The subject has a history of allergic reaction to, intolerances of or contraindications for any of the study medications or required anesthetic agents. 2. The subject has received or is expected to receive any excluded preoperative drug within 48 hours prior to induction; or is expected to receive any excluded intra-operative or postoperative medications. 3. The subject is pregnant or lactating. (If the potential subject is pre-menopausal, a urine pregnancy test must be performed within 24 hours/1 day of study prior to the planned surgery time and confirmed negative in order for the potential subject to be enrolled). 4. The subject is taking warfarin. 5. The subject has a history of alcohol and/or drug abuse within 1 year of study medication, or has a positive screening or pre-study test for alcohol or drugs of abuse. 6. The subject is expected to require the use of a nasogastric tube postoperatively. 7. The subject has a diagnosed latex allergy. 8. The subject has used oral aprepitant (Emend®) within the last 30 days. 9. The subject has participated in a randomized study or has been exposed to any experimental drug within 30 days prior to enrollment of this study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Contraception Healthy females who want oral contraception No cervical or vaginal abnormalities on gynecological examination Negative Chlamydia test Pap smear without evidence of moderate or severe dysplasia or any malignancy within the preceding 12 months Negative urine pregnancy test conducted during Visit 1 One normal menstrual period in 35 days prior to Visit 1 Regular menstrual cycles (every 26-35 days) Last term pregnancy at least 42 days prior to Visit 1, and have had at least one normal menstrual period (typical in duration and amount of flow for the subject) since her last pregnancy Post-menarcheal and pre-menopausal At least one normal menstrual period (typical in duration and amount of flow for the subject) since having undergone uterines urgery or removal of an IUD, Norplant, DepoProvera or other hormonal injectables or implants History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy Previously discontinued ORTHO TRI-CYCLEN LO or YAZ due to breakthrough bleeding Pregnant or lactating Body mass index (BMI) of >40kg/m2 Clinical evidence of carcinoma or other malignancy (history of basal cell carcinoma of the skin is not exclusionary) History of alcohol or drug abuse in the investigator's judgment based on history and physical examination (within 12 months prior to Visit 1) Significant depression or psychiatric disease in the investigator's judgment based on history and physical examination which would result in an unreliable patient Patient deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information Have any medical condition or planned surgical procedure which, in the opinion of the investigator, may be exacerbated by treatment with study medication or a patient receiving any concurrent therapy that could be affected by treatment with study medication Disallowed therapies: currently taking therapeutic anticoagulants (e.g,. Coumadin, Heparin) or have a bleeding disorder (e.g. von Willebrand's Disease), DepoProvera or other hormonal injectables in the six months before Visit 1, currently have Norplant or other hormonal implants in place, or have had removal of Norplant within 60 days prior to Visit 1, used a steroid-containing IUD within 3 months prior to Visit 1
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1
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Contraception Signed and dated informed consent Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive) at Visit 1 Otherwise healthy female subjects requesting contraception and currently using a LNG, NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and suffering from at least moderate pelvic pain, headache or both defined by an average of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is the expected standard deviation of the population VAS reduction) Normal or clinically insignificant cervical smear not requiring further follow up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the last 6 months before screening) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation before start of treatment) Body mass index (BMI) >32 kg/m2 Hypersensitivity to any of the study drug ingredients Individuals not willing to consume pork and beef products. Women may be included if they are willing to take the capsules Safety relevant laboratory values, provided by the central laboratory, outside range before start of treatment Any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication (such as but not limited to duodenal ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise) Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment Undiagnosed abnormal genital bleeding Abuse of alcohol, drugs, or medicines (eg, laxatives)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with active disease. 2. Patients must be age 18 or over at the signing of consent and must understand and voluntarily sign an informed consent. 3. Prior treatment with purine analog based chemotherapy or chemoimmunotherapy. 4. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0-2. 5. Adequate renal function indicated by serum creatinine less or equal to 2 mg/dl. Adequate hepatic function indicated as total bilirubin less or equal to 2 mg/dl and ALT less or equal to two times the upper limit of normal. 6. Disease free of prior malignancies for 3 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. Patients with malignancies with indolent behavior such as prostate cancer treated with radiation or surgery can be enrolled in the study as long as they have a reasonable expectation to have been cured with the treatment modality received. 7. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (sensitivity of at least 50 milli-International unit (mIU/mL) 10-14 days prior to starting lenalidomide. A female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 8. Continued from #7. FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts talking lenalidomide. FCBP must also agree to ongoing pregnancy testing. 9. Continued from #8: Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. 10. Men must agree not to father a child. They must agree to use a latex condom during sexual contact with females of childbearing potential while participating in the study and for at least 28 days following discontinuation from the study even if he has undergone a vasectomy. They will be warned that sharing study drug is prohibited and will be counseled about pregnancy precautions and potential risks of fetal exposure. They must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from the study. 11. Continued from #10: Counseling about the requirement for latex condom use during sexual contact with females of childbearing potential and the potential risks of fetal exposure must be conducted at a minimum of every 28 days. During counseling, subjects must be reminded not to share study drug and to not donate blood, sperm, or semen (during study participation and for 28 days following discontinuation from the study) Known sensitivity to lenalidomide or other thalidomide derivatives or rituximab. 2. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood). 3. Known positivity for HIV or active hepatitis (B or C). 4. Pregnant or breast feeding females. 5. History of tuberculosis treated within the last five years or recent exposure to tuberculosis. 6. Any serious medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk if he/she were to participate in the study. 7. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus (PE), in the six months prior to enrollment are not eligible for this study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 21.0-55.0, Flu Men and women 21-55 years old Willingness to participate in the study for a full year including multiple blood draws and PET-CT scanning Diabetes Use of systemic steroids Pregnancy or unwillingness to practice birth control of some kind through the PET-CT scanning period Recent vaccination for other reasons (e.g., traveler's vaccines) Significant intercurrent illness that might interfere with vaccination "take" or interpretation of PET-CT scanning (e.g., chemotherapy for cancer)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Fertility Women 18 years or older Can understand written and spoken English Current or past user of DMPA or desires initiation of DMPA for contraception Provider has approved DMPA use in this woman Willing to consider/attempt DMPA self-injection Willing to receive phone calls/letter for follow up Willing to return letters for follow up Has contraindications to DMPA use Vaginal bleeding of unknown etiology Medication use for Cushing's syndrome Currently pregnant Blood pressure >160/100 Intolerance to the idea of irregular or absent menses
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Influenza Male and female adults 18 to 64 years of age at time of first vaccination, inclusive Written informed consent obtained from the subject Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits Subjects who the investigator believes can and will comply with the requirements of the protocol Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if clinically stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Diagnosed with cancer, or treatment for cancer, within 3 years Presence of an oral temperature >= 37.8ºC, or acute symptoms greater than "mild" severity on the scheduled date of vaccination Any confirmed or suspected immunosuppressive or immunodeficiency condition including history of human immunodeficiency virus (HIV) infection Receipt of systemic glucocorticoids (prednisone >= 10 mg/day for more than 14 consecutive days) within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin Administration of any vaccines within 30 days before the first study vaccine dose Previous administration of any H5N1 vaccine Use of any investigational or non-registered product (drug or vaccine) or planned participation in another investigational study within 30 days prior to study enrollment, or during the 12 months following test article administration. Use of any investigational or non-registered product with immunosuppressive properties is exclusionary at any time during the trial
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? 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 stndy? 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 indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? 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 h/story (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? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? 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? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Healthy Is the individual a healthy, normal adult man and woman who volunteers to participate? ls s/he at least 18 years of age? 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 stndy? 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 indicated that the individual was ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to amlodipine? 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 h/story (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? Has s/he consumed grapefruit or grapefruit juice during the 7rday period preceding study initiation? 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? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation? Has s/he donated plasma during the two week period preceding study initiation? Has s/he received an investigational drug during the 30 day period preceding study initiation? Is s/he a heavy smoker (usually smoking more than 10 cigarettes per day)?
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-55.0, Healthy Healthy adult male or female volunteers, 18-55 years of age 2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983) 3. Medically healthy subjects with clinically normal laboratory profiles 4. Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum IUD in place for at least 3 months barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and throughout the study surgical sterilization of the partner (vasectomy for 6 months minimum) hormonal contraceptives for at least 3 months prior to the start of the study Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible. 5. Voluntarily consent to participate in the study Subject candidates must not be enrolled in the study if they meet any of the following 1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease 2. In addition, history or presence of alcoholism or drug abuse within the past 2 years hypersensitivity or idiosyncratic reaction to anticonvulsants 3. Female subjects who are pregnant or lactating 4. Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose 5. Subjects who, through completion of the study, would have donated in excess of mL of blood in 14 days, or mL of blood in 14 days (unless approved by the Principal Investigator) mL of blood in 90 days mL of blood in 12 days mL of blood in 180 days mL of blood in 270 days mL of blood in I year 6. Subjects who have participated in another clinical trial within 28 days prior to the first dose
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Pelvic Inflammatory Disease women admitted to Emergency with pelvic-inflammatory disease or tubo-ovarian abscess from the year range: 1995-2000
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Influenza Pandemic Influenza Subjects who Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry Are clinically healthy, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination Are physically and mentally capable of participating in the study Are willing to refrain from blood donation for the duration of Part A of the study (until Day 42 [= 21 days after the second vaccination]) Agree to keep a daily record of symptoms for the duration of the study If female and capable of bearing children have a negative urine pregnancy test result within 24 hours of the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study Subjects will be excluded from participation in this study if they Have a history of exposure to H5N1 influenza virus or a history of vaccination with an H5N1 influenza vaccine Are at potential occupational risk of contracting H5N1 influenza infection (e.g., poultry workers) Suffer from or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, rheumatic, autoimmune, hematological, metabolic or renal disorder Have a Body Mass Index > 35 Have hypertension at screening that is graded as greater than Stage 1 (defined as a systolic pressure > 159 or diastolic pressure > 99) while seated and at rest (measurement shall be repeated twice before subject is excluded) Have clinically significant abnormal clinical laboratory values at screening as determined by the Investigator Have clinically significant electrocardiographic abnormalities at screening Test positive for HIV, HBcAb or HCV Suffer from any kind of immunodeficiency
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 21.0-45.0, Lactation Bone Diseases, Endocrine Group 1: Post-partum (singleton pregnancy) African-American women who are exclusively breastfeeding, defined as 1 or fewer bottles of supplemental formula/day Group 2: Post-partum (singleton pregnancy) African-American women are non-lactating, which is defined as bottle-feeding or having weaned their baby from breastfeeding for at least 4 weeks prior to study Group 3: Controls Healthy non-pregnant African-American women will be race and age-matched to the breast-feeding women in group one. They may not have been lactating or pregnant within the last year Subjects with cardiac, hypertensive, vascular, renal (serum creatinine of >1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease will be excluded from the study Smokers and those with a history of significant alcohol or drug abuse are excluded Baseline hypertension (systolic BP > 160 mm/Hg) or hypotension (systolic BP < 90 mm/Hg) Subjects taking any chronic medications except stable doses of thyroid hormone, prenatal, vitamin supplements, or oral contraceptives Those who have received any investigational drug in past 90 days will be excluded from the study Women who are currently pregnant will be excluded from the study. Women who became pregnant by In Vitro Fertilization IVF or any hormonal manipulation (i.e. fertility drugs such as clomid ®) are also excluded, as they may have an altered pre-pregnant hormonal state. All women will have a urine pregnancy test performed at each of the two study visits and must not be pregnant in order to continue in the study. Subjects are not allowed to donate blood between study visits
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Asthma Eczema Allergy (mother) Pregnant women Living in Sealand, Denmark Fluent in Danish Language Willing to let the newborn child participate in the study (mother) Participating in other clinical trial
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 16.0-50.0, Bacterial Vaginosis Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following must be met for enrolment in the study: 1. ages 16-50 and premenopausal; 2. capable of giving written informed consent; 3. English speaking; 4. negative pregnancy test on enrolment day; 5. agree to follow study protocol; 6. documented BV infection by positive vaginal swab +/ positive whiff test/pH > 4.5; 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable); 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices); 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication); 10. agree to no new medications or antibiotics during treatment; 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas; 12. patient is reliable for follow up The following women would be excluded from study participation: 1. less than 16 or post-menopausal; 2. negative vaginal swab regardless of whiff test/pH > 4.5; 3. menstruating at diagnosis; 4. symptoms so severe as to make allocation to placebo unacceptable to the patient; 5. currently pregnant or at high risk for pregnancy; 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV); 7. current yeast infection as determined by history, physical and swabs; 8. history of PID; 9. allergy to latex or metronidazole; 10. presently lactating; 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam; 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response; 13. using lithium, anti-coagulants or disulfiram drugs; 14. any antifungal or antibiotic use 14 days prior to enrolment 15. PAP smear done within one week of enrollment
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Norovirus Signed written informed consent 2. Age 18 years, inclusive 3. Good general health as determined by a screening evaluation within 30 days before administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo 4. Expressed interest and availability to fulfill the study requirements 5. Agrees not to become pregnant from the time of study enrollment until at least 56 days after the last administration of Norwalk VLP Vaccine, adjuvant/excipients or placebo; if a woman is sexually active and capable of conception (i.e., no history of hysterectomy or tubal ligation), she must agree to use hormonal or barrier birth control. A woman is eligible if she is monogamous with a male who has had a vasectomy. 6. Demonstrated to be an H type-1 antigen secretor 7. Agrees not to participate in another clinical trial with an investigational product for the entire duration of the study (six months after the last study dose i.e. 201 days) 8. Agrees to storage of unused clinical specimens for an indefinite period of time only for those specimens collected by the University of Maryland CVD for use in future research at the CVD. [A University of Maryland site-specific criterion] History of any of the following medical illnesses Chronic rhinitis, runny nose, sneezing Clinically significant nose bleed within the last year Diabetes Cancer Heart disease (hospitalization for a heart attack, arrhythmia, or syncope) Unconsciousness (other than a single brief "concussion") Seizures (other than febrile seizures as a child <5 years old) Recurrent infections (more than 3 hospitalizations for invasive bacterial infections such as pneumonia or meningitis) Asthma requiring treatment with inhaler or medication
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Subjects 18 to 59 years of age, or 60 years of age and older, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol; 2. Are in good health or have one or more stable (See footnote) medical conditions, as determined by: 1. Medical history, 2. Physical examination, 3. Clinical judgment of the medical investigator; 3. Are able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits. 4. Subjects who experienced fever (defined as axillary temperature >38oC) within 3 days prior to Visit 1; 5. Subjects who are pregnant or breastfeeding; 6. Females of childbearing potential who refuse to use an acceptable method of birth control for a period of 56 days before and after each vaccination. Adequate contraception is defined as hormonal (e.g., oral, injection, transdermal patch, implant, cervical ring), barrier (e.g., condom with spermicide or diaphragm with spermicide), intrauterine device (e.g., IUD), monogamous relationship with vasectomised partner who has been vasectomised for 6 months or more prior to the subject's study entry, or abstain from heterosexual intercourse (e.g., through sexual orientation or religious or other beliefs about premarital intercourse); 7. Subjects with any serious disease, including: 1. cancer, 2. acute or progressive hepatic disease, 3. acute or progressive renal disease, 4. chronic pulmonary disease requiring home oxygen therapy, 5. active neurological disorder, 6. autoimmune disease (including rheumatoid arthritis); 8. Subjects for whom surgery is planned during the study period; 9. Subjects with a bleeding diathesis; 10. Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or kanamycin, or any other component of the study vaccine; 11. Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine; 12. Subjects with known or suspected impairment/alteration of immune function, for example, resulting from: 1. receipt of oral immunosuppressive therapy (e.g., corticosteroid therapy or cancer chemotherapy) (long-term, inhaled steroids for asthma management is acceptable), 2. receipt of immunostimulants or interferon, 3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visits 1 (Day 1), 2 (Day 22), or 5 (Day 382), or planned during the full length of the study, 4. high risk from developing an immunocompromising disease; 13. Actual or planned receipt of another vaccine during the period 3 weeks before to 3 weeks after vaccination on Days 1, 22, and 382; 14. Subjects with a history of (or current) drug or alcohol abuse (20g/day for females; 30g/day for males) that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives; 15. Subjects who are unable to lead an independent life either physically or mentally; 16. Have participated in a previous study of H5 avian influenza vaccine; 17. Have been previously vaccinated with a vaccine containing MF59 or similar adjuvant; 18. Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.5-999.0, Influenza Unvaccinated patients presenting to the Emergency Department aged 6 months or more who have at least one high risk attribute Age 6-59 months or >50 years Pregnant Health care worker Aged 6 months-18 years on chronic aspirin therapy Comorbidity (cardiovascular disease, pulmonary disease, metabolic disease, renal disease, hepatic disease, seizures, neuromuscular disease, cognitive dysfunction, or any reason to have had regular medical follow up or hospitalization in the preceding year) Household contact or caregiver of someone with at least one high risk attribute Prior vaccination History of Guillan-Barre syndrome within 6 weeks of prior influenza vaccination Allergy to influenza vaccination or eggs Age < 6 months old Fever with more than minor illness Hospitalization
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Human Papillomavirus Infection Female partners of HIM Study participants report no abnormal Pap smear during the past 6 months have not had a hysterectomy have never been diagnosed with genital warts are not pregnant residents of southern Florida are not and have not been enrolled in an HPV vaccine trial willing to comply with scheduled visits every 6 months for 2 years Do not meet the Criteria
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Stress Healthy first-time mothers with singleton baby delivered at term with no complications Mothers with chronic health problems Pregnancy complications, OR Infants with congenital problems or conditions requiring admission to the intensive care nursery
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Influenza, Human A subject must meet all of the following 1. 18 to 70 years old. 2. Available for clinical follow-up through Week 24. 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly. 5. Able and willing to complete the informed consent process. 6. Willing to donate blood for sample storage to be used for future research. 7. No evidence of previously undiagnosed clinically significant chronic diseases. 8. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) greater than or equal to 18.5 and less than 40 within the 28 days prior to enrollment. Laboratory within 56 days prior to enrollment: 9. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men 10. White blood cells (WBC) = 3,300-12,000 cells/mm(3) 11. Differential either within institutional normal range or accompanied by site physician approval as a differential that is consistent with healthy volunteer status 12. Total lymphocyte count greater than or equal to 800 cells/ mm(3) 13. Platelets = 125,000 000/ mm(3) 14. Alanine aminotransferase (ALT) less than or equal to 2.5 times the upper limit of normal (ULN) 15. Serum creatinine less than or equal to 1 x ULN (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males) and estimated glomerular filtration rate greater than 60. 16. Negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]. Female-Specific 17. Negative human chorion gonadotropin (beta-HCG) pregnancy test (urine or serum) for women presumed to be of reproductive potential. 18. A female subject must meet one of the following No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, OR Agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 24 of the study, OR Agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 24 of the study by one of the following methods condoms, male or female, with or without a spermicide diaphragm or cervical cap with spermicide intrauterine device contraceptive pills, patch, implant or any other FDA-approved contraceptive method male partner has previously undergone a vasectomy A subject will be excluded if one or more of the following conditions apply. Women Specific: 1. Breast-feeding or planning to become pregnant during the first 28 weeks after enrollment in the study. Subject has received any of the following substances: 2. Systemic immunosuppressive medications or cytotoxic medications, within the 12 weeks prior to enrollment. [With the exceptions that a short-acting beta-agonists in controlled asthmatics; or a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not study participation.] 3. Immunized with a current season FDA-approved influenza vaccine prior to enrollment. 4. Influenza infection within 6 months prior to enrollment (as assessed by clinician review of subject's self-report of a clinical course consistent with influenza). 5. Blood products within 112 days (16 weeks) prior to HIV screening 6. Immunoglobulin within 56 days (8 weeks) prior to HIV screening 7. Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration 8. Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration 9. Medically indicated subunit or killed vaccines (e.g., pneumococcal, or allergy treatment with antigen injections) within 14 days (2 weeks) of initial study vaccine administration 10. Current anti-TB prophylaxis or therapy Subject has a history of any of the following clinically significant conditions: 11. Autoimmune disease or immunodeficiency. 12. Contraindication to receiving an FDA approved current seasonal influenza vaccination (e.g., egg allergy). 13. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator. 14. Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema. 15. Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids. 16. Diabetes mellitus (type I or II), with the exception of gestational diabetes. 17. Thyroid disease that is not well controlled. 18. Idiopathic urticaria within the past 1 year. 19. Hypertension that is not well controlled by medication or is more than 145/95 at enrollment. 20. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 21. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study. 22. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years. 23. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. 24. Guillain-Barr Syndrome. 25. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Healthy or Stable Underlying Chronic Medical Condition Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her eighteenth year birthday but not yet reached his or her 50th year birthday) at the time of the dose of blinded investigational product Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], had a sterile male partner, was at least 1 year post-menopausal, or practiced abstinence) must have used an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the subject must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 did not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment was required to assess a female subject's capability of pregnancy Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization was not required in the previous year Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol Subject available by telephone Able to understand and comply with the requirements of the protocol, as judged by the investigator Acute illness or evidence of significant active infection at randomization Fever ≥ 100.4°F (38°C) at randomization History of asthma Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives or chronic medications that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization Previous medical history or evidence of an intercurrent illness that might have compromised the safety of the subject in the study Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids were permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30-day window around dose of investigational product Note: topical corticosteroids for uncomplicated dermatitis were permitted according to the judgment of the investigator; topical calcineurin inhibitors were permitted in accordance with their package insert at entry and during study participation Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation Receipt of any investigational drug therapy or standard vaccine within 30 days before the dose of investigational product in this study through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted) Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV) History of allergic disease or reactions likely to be exacerbated by any component of the investigational product including allergy to eggs, egg proteins, gentamicin, or gelatin; or serious, life threatening, or severe reactions to previous influenza vaccinations
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-45.0, Premenstrual Syndrome Person is over the age of 20 but not older than age 45. 2. Person is willing to participate as evidenced by signing the written informed consent form. 3. Suffers from known dominant severe symptom of breast swelling and tenderness (level 7-10 according to standard scale of PMS symptoms severity) 4. Other severe symptoms of Premenstrual syndrome (based on WHO and ACOG criteria). This may one or more of PMS symptoms with level 7-10 according to standard scale of PMS symptoms severity. 5. At work, school, home, or in daily routine, at least one of the PMS symptoms caused reduction of productivity or inefficiency 6. At least one of the PMS symptoms caused avoidance of or less participation in hobbies or social activities 7. At least one of the PMS symptoms interfere with relationships with others: i. Timing of PMS symptom(s): during the 14 days prior to onset of menstrual flow (rather than spotting) and up to 5 days during the menstrual flow. ii. Pattern and length of PMS symptomatic period: minimum of 2 days, up to 14 days. iii. For PMS diagnosis two out of last three consecutive menstrual cycles were monitored by daily monitoring of symptoms. iv. Timing and length of asymptomatic phase: day 6 to at least day 10 of the menstrual cycle. v. Cyclicity presentation of the 'off-on' phenomenon: there should be a clear shift from no PMS symptoms to PMS symptoms. vi. Reliable non hormonal contraception Pregnant or lactating woman 2. Oral contraceptives during last three months, including hormonal IUD (trade name mirena). 3. Serious health problems. 4. Unexplained menstrual disorders. 5. Treated by hormones (estrogen and progesterone). 6. For healthy: Irregular or abnormal test results
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 19.0-50.0, Influenza Healthy Healthy volunteers (as concluded from the medical history, physical examination, and clinical judgment) aged 19 to 50 years old Females using a reliable method of contraception (from 4 weeks prior to the first vaccination until 4 weeks after the second vaccination) and a negative urine pregnancy test will be required before administration of each dose of vaccine Signed informed consent Subjects able to understand and comply with the study protocol and complete the Adverse Event Form Subjects able to attend the scheduled visits Subjects with normal pre-screening values. If a subjects prescreening samples lie outside the reference values he/she will only be included in the study based upon the medical evaluation of the clinical investigator Persons with a history of anaphylaxis or serious reactions to any vaccine Persons with known hypersensitivity to any of the vaccine components Persons who have had a temperature >38oC during the previous 72 hours Persons who have had an acute respiratory infection during the last 7 days Women who are pregnant or breast-feeding Persons with chronic illness at any stage that could interfere with trial conduct or compliance Persons who have received blood products or immunoglobulins parenterally during the previous 3 months Persons who have been vaccinated with any vaccine during the 4 weeks preceding the first trial vaccination Persons with known or suspected immunosuppressive disease or who use systemic immunosuppressive drugs Persons taking immunostimulant therapy
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Healthy Healthy males and females between 18 and 55 years (inclusive) of age Non-smoking (by declaration) for a period of at least 6 months Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study Haematology and Chemistry values within normal ranges or with no clinical significance Subjects who provide written informed consent to participate in the study Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications Ongoing flu symptoms or influenza Any clinically significant abnormality upon physical examination or in the clinical laboratory test at screening visit Treatment with immune immunosuppressant drugs or other immune enhancing drugs Subjects who have been immunized with anti-influenza vaccine or infected by influenza virus within one year prior to the screening visit Administration of any vaccine 30 days before the screening visit Known history of drug or alcohol abuse Known history of HIV, hepatitis C or B virus (HCV or HBV) Subjects with known Guillain Barré Syndrome in the past or more hospitalization within the last year prior to screening visit
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-59.0, Influenza Avian Influenza Male and female subjects will be eligible for participation in this study if they are 18 to 59 years of age, inclusive, on the day of screening have an understanding of the study and its procedures, agree to its provisions, and give written informed consent prior to study entry are generally healthy, as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination are physically and mentally capable of participating in the study and follow its procedures agree to keep a daily record of symptoms for the duration of the study if female of childbearing potential: have a negative urine pregnancy test result within 24 hours prior to the scheduled first vaccination and agree to employ adequate birth control measures for the duration of the study Subjects will be excluded from participation in this study if they have a history of exposure to H5N1 virus or a history of vaccination with an H5N1 influenza vaccine are at high risk of contracting H5N1 influenza infection (e.g. poultry workers) currently have or have a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder have any inherited or acquired immunodeficiency have a disease or are currently undergoing a form of treatment or were undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (> 800µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs have a history of severe allergic reactions or anaphylaxis have a rash, dermatological condition or tattoos which may interfere with injection site reaction rating have received any blood products or immunoglobulins within 90 days prior to study entry have donated blood or plasma within 30 days prior to study entry
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Contraception Requiring contraception Normal cervical smear Maximum age for smokers is 35 History of regular cyclic menstrual periods Pregnancy or lactation Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Use of other contraceptive methods than study medication
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Hepatitis C Healthy female subjects between the ages of 18 and 45 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests) Subjects must have been on any combination of ethinyl estradiol and levonorgesterol oral contraceptives for at least one consecutive month prior to Period 1 Body Mass Index (BMI) of approximately 17.5 to 30.5 kg/m2; and a total body weight >45 kg Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures Must be willing to practice an alternative method of contraception for the duration of the study in addition to oral contraceptive use Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) Any medical reason which would contraindicate the administration of oral contraceptives (as per label). Including but not limited to history of unexplained vaginal bleeding, current breast cancer, active liver disease, uncontrolled hypertension, history of diabetes with vascular complications, history of venous thrombosis, stroke, ischemic heart disease, history of severe headaches with focal neurologic symptoms Female subjects of non-childbearing potential who meet the following Post menopausal, aged between 45-55 who have been amenorrheic for >2 years and who meet the for serum FSH levels (>30 IU/L), or Females who have undergone a hysterectomy, or Females who have undergone tubal ligation, or Females who have undergone bilateral oophorectomy History of discontinued use of oral contraceptives for medical reasons History of febrile illness within 5 days prior to the first dose Any condition possibly affecting drug absorption (eg, gastrectomy)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Contraception Female subject requesting contraception Age: 18 years (inclusive); smokers must not be older than 35 years at the time of informed consent Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at screening visit or a normal result has to be documented within the previous 6 months) History of regular cyclic menstrual periods Pregnancy or lactation Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic) Use of other contraceptive methods than study medication
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-45.0, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Influenza Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol. 2. Male or female subjects 18-50 years who are either healthy or have a stable medical condition. 3. Able to understand and comply with all study procedures and to complete study diaries 4. Individuals who can be contacted throughout the study and are available for all study visits 5. Females should either be using secure contraceptive precautions including the oral contraceptive pill condom/barrier contraception partner has had a vasectomy be surgically sterilised, or post-menopausal (defined as at least two years since the last menstrual period) Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, autoimmune illnesses (including rheumatoid arthritis), acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder. 2. Individuals with a history of anaphylaxis or serious reactions to vaccines; hypersensitivity to influenzal viral protein, neomycin or polymixin, or products containing mercury. 3. Persons with known immunosuppressive disease or who use systemic immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process, or have received in the last 6 months radiotherapy or chemotherapy. 4. Subjects who are at high risk of developing illnesses of the immune system. 5. Individuals who are taking immunostimulant therapy or interferon 6. Individuals who have received blood products or immunoglobulins parenterally during the preceding three months. 7. Women should not be pregnant or lactating. 8. Women who refuse to use a reliable contraceptive method throughout the study 9. Known or suspected drug abuse. 10. Individuals who have received another vaccine or investigational medicinal product in the preceding 2 weeks. 11. Unable to lead an independent life either physically or mentally 12. Regularly drink more than 40 units of alcohol weekly 13. Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable). 14. Individuals who had a temperature >38oC in the preceding 3 days. 15. Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results. 16. Individuals who have had confirmed pandemic influenza H1 infection
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Seasonal Influenza Subject is 18 to 59 years of age , inclusive, at the time of screening (for subjects in age stratum A only) Subject is 60 years of age or older , inclusive, at the time of screening (for subjects in age stratum B only) Subject has given written informed consent prior to study entry Subject is generally healthy , as determined by the investigator's clinical judgment through collection of medical history and performance of a physical examination, such that the investigator would not hesitate to provide routine influenza immunization to the subject in the course of routine medical practice Subject agrees to keep a daily record of symptoms for the duration of the study If female of childbearing potential, subject presents with a negative urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study Subject is willing and able to comply with the requirements of the protocol Subject has a history of severe allergic reaction or anaphylaxis Subject has an oral temperature of >= 37.5°C on the day of vaccination in this study Subject has a rash or dermatologic condition or tattoos, which may interfere with injection site reaction rating Subject has received a live vaccine within 4 weeks or an inactivated or subunit vaccine within 2 weeks of study entry Subject has received a seasonal influenza vaccine within 6 months of study entry Subject currently has or had a history of a significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, hematological or renal disorder Subject has any inherited or acquired immunodeficiency Subject has a disease or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled (>800 µg/day of beclomethasone dipropionate or equivalent) corticosteroids, radiation treatment or other immunosuppressive or cytotoxic drugs Subject has a functional or surgical asplenia Subject has a known or suspected problem with alcohol or drug abuse
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Are males or non-pregnant females age 18 and older, inclusive Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 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 during the study for at least 30 days following the last vaccination Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this criterion Are able to understand and comply with planned study procedures Provide written informed consent prior to initiation of any study procedures Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein) Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential), or women who are breastfeeding Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.) Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the study period (prior to Day 180 after the third vaccination)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Swine-origin A/H1N1 Influenza Aged 18 years or over on the day of Informed Consent Form 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 after the last vaccination Entitled to national social security At Visit 05, for antibody persistence assessment Addendum 1 to Informed Consent Form has been signed and dated Having received two vaccinations with the vaccine formulation 1 or 2. At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine Addendum 2 to Informed Consent Form has been signed and dated Known pregnancy, or a positive urine pregnancy test Currently breastfeeding a child Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Receipt of any vaccine in the 4 weeks preceding the first trial vaccination Planned receipt of any vaccine prior to the Day 42 blood sample Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C 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
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.5-17.0, Influenza Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks) Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Are males or non-pregnant females age 18 and older, inclusive. 2. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 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 during the study for at least 30 days following the last vaccination. 3. Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and limited physical examination. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this criterion. 4. Have alanine aminotransferase (ALT) within normal range per local or site laboratory reference ranges. 5. Are able to understand and comply with planned study procedures. 6. Provide written informed consent prior to initiation of any study procedures Have a known allergy to eggs or other components of the vaccine (including squalene based adjuvants, gelatin, formaldehyde, octoxinol, thimerosal, and chicken protein). 2. Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential), or women who are breastfeeding. 3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months. 4. Have an active neoplastic disease or a history of any hematologic malignancy. 5. 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.) 6. Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis. 7. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years. 8. Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study. 9. Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study. 10. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 386 clinic visit days after the second vaccination). 11. Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination. This is inclusive of seasonal influenza vaccines. 12. Have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe, or would interfere with the evaluation of responses. 13. Have a history of severe reactions following previous immunization with influenza virus vaccines. 14. Have an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 3 days prior to vaccination. 15. Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol. 16. Participated in a novel influenza H1N1 2009 vaccine study in the past 2 years or have a history of novel influenza H1N1 2009 infection prior to enrollment. 17. Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection or autoimmune hepatitis. 18. Have a history of alcohol or drug abuse in the last 5 years. 19. Plan to travel outside of North America in the time between the first vaccination and 42 days following the first vaccination. 20. Have a history of Guillain-Barré Syndrome. 21. Have any condition that the investigator believes may interfere with successful completion of the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-99.0, Influenza Are males or non-pregnant females age 18 and older, inclusive Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 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 during the study for at least 30 days following the last vaccination Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and limited physical examination. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this criterion Have erythrocyte sedimentation rate (ESR) less than 30 mm per hour Are able to understand and comply with planned study procedures Provide written informed consent prior to initiation of any study procedures Have a known allergy to eggs or other components of the vaccine (including squalene based adjuvants, thimerosal, neomycin, polymyxin, and chicken protein) Have a positive urine or serum pregnancy test within 24 hours prior to vaccination if female of childbearing potential or women who are breastfeeding Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.) Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 386 clinic visit
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Influenza Any patient admitted to hospital with suspected or confirmed influenza infection Patients who do not give their consent
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Influenza A Virus, H1N1 Subtype Novel Swine-Origin 18 to 70 years old. 2. Available for clinical follow-up through Week 32. 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly. 5. Able and willing to complete the informed consent process. 6. Willing to donate blood for sample storage to be used for future research. 7. No evidence of previously undiagnosed clinically significant chronic diseases. 8. Physical examination and laboratory results without clinically significant findings, no fever (greater than or equal to 100.4 degree F) in the 72 hours prior to enrollment, and a Body Mass Index (BMI) greater than or equal to 18 and < 42 within the 56 days prior to enrollment. Laboratory within 56 days prior to enrollment: 9. Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men 10. White blood cells (WBC) = 3,300-12,000 cells/mm(3) 11. Differential either within institutional normal range or accompanied by site physician approval as a differential that is consistent with healthy volunteer status 12. Total lymphocyte count greater than or equal to 800 cells/mm(3) 13. Platelets = 125,000 000/mm(3) 14. Alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal (ULN) 15. Serum creatinine less than or equal to 1 times ULN (less than or equal to 1.3 mg/dL for females; less than or equal to 1.4 mg/dL for males) and estimated glomerular filtration rate > 60 mL/min/1.73 m(2). 16. Negative FDA-approved HIV blood test. [Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study]. Female-Specific 17. Negative human chorionic gonadotropin (HCG) pregnancy test (urine or serum) for women presumed to be of reproductive potential on the day of enrollment. 18. A female subject must meet one of the following No reproductive potential because of menopause [one year without menses] or because of a hysterectomy, bilateral oophorectomy, or tubal ligation, OR Agrees to be heterosexually inactive at least 21 days prior to enrollment and through Week 32 of the study, OR Agrees to consistently practice contraception at least 21 days prior to enrollment and through Week 32 of the study by one of the following methods: (Bullet) condoms, male or female, with or without a spermicide; (Bullet) diaphragm or cervical cap with spermicide; (Bullet) intrauterine device; (Bullet) contraceptive pills, patch, implant or any other FDA-approved contraceptive method; (Bullet) male partner has previously undergone a vasectomy Women Specific: 1. Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment in the study. Subject has received any of the following substances: 2. Systemic immunosuppressive medications or cytotoxic medications within the 12 weeks prior to enrollment. [With the exceptions that a short course (duration of 10 days or less or a single injection) of corticosteroids for a self-limited condition at least 2 weeks prior to enrollment in this study will not study participation.] 3. Blood products within 112 days (16 weeks) prior to HIV screening 4. Immunoglobulin within 56 days (8 weeks) prior to HIV screening 5. Live attenuated vaccines within 28 days (4 weeks) prior to initial study vaccine administration 6. Investigational research agents within 28 days (4 weeks) prior to initial study vaccine administration 7. Medically indicated subunit or killed vaccines (e.g., pneumococcal, or allergy treatment with antigen injections) within 14 days (2 weeks) of initial study vaccine administration 8. Current anti-TB prophylaxis or therapy Subject has a history of any of the following clinically significant conditions: 9. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by investigator. 10. Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic forms of angioedema. 11. Asthma that is severe, unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral, intravenous, or high dose inhaled corticosteroids. 12. Diabetes mellitus type I. 13. Thyroid disease that is not well-controlled. 14. Generalized idiopathic urticaria within the last 1 year. 15. Hypertension that is not well controlled by medication or is more than 145/95 at enrollment. 16 Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws. 17. Malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of the study. 18. Seizure disorder other than: 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years. 19. Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen. 20. Guillain-Barr Syndrome. 21.Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide plan or attempt. 22. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza A male or female aged 18 years or above at the time of the first vaccination Subjects who the investigator believes that they can and will comply with the requirements of the protocol Written informed consent obtained from the subject Satisfactory baseline medical assessment by history and physical examination. Stable health status is defined as the absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within one month prior to enrolment Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device Female subjects of non-childbearing potential may be enrolled in the study Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause 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 Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Potential subjects in the follow-up phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence of an axillary temperature >= 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other continue to be satisfied Diagnosed with cancer, or treatment for cancer, within the past 3 years Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible Persons with a history of histological-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and may enrol within 3 years of diagnosis, but other histological types of skin cancer require a 3 year untreated and disease-free window as above Women who are disease-free 3 years or more after treatment for breast cancer and receiving long-term prophylactic hormonal therapy are excepted and may enrol Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male and female adults, >= 18 years of age at the time of the first vaccination Satisfactory baseline medical assessment by history and physical examination Safety laboratory test results within the parameters specified in the protocol 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 as demonstrated by signature on the informed consent document Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line, or mobile, but NOT a pay phone or other multiple-user device 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 Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0 Planned administration of any vaccine other than the study vaccines between Day 0 and the phlebotomy 21 days after vaccination Planned administration of any monovalent pandemic (H1N1)v-like vaccine other than the study vaccines during the whole study (Day 0 Day 385) Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence of a temperature >= 38.0ºC (>= 100.4 ºF), oral temperature assessment preferred, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Diagnosed with cancer, or treatment for cancer, within 3 years
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-60.0, Sexual Dysfunction Breast Cancer Survivors breast cancer survivors over 20 years-old premenopausal at the time of diagnosis treated with operation and chemotherapy newly developed dyspareunia after cancer treatment recent (< 2 months) start or cessation of hormonal treatment (tamoxifen etc.) depression or other psychological problems active vaginal infection evidence of cancer recurrence previously use of lactate-containing lubricants other chronic diseases which severely disturb the sexual life
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male and female adults, >= 18 years of age at the time of the first vaccination Safety laboratory test results within the parameters specified in the protocol 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 as documented by signature on the informed consent document Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device 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 Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Diagnosed with cancer, or treatment for cancer, within 3 years Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required) Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 12.0-999.0, Influenza A Swine Flu Individuals confirmed and suffering from Influenza A Individuals suffering from influenza included in the high risk group
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Healthy Adults Age 18 and 49 years, inclusive In good health as evidenced by screening evaluation within the 30 days prior to immunization Expressed interest and availability to fulfill the study requirements Signed, informed consent For women of child-bearing potential, agreement to avoid pregnancy for the 90 days following vaccination by use of effective birth control methods Agreement to refrain from taking any experimental drug or vaccine from Day minus 30 to Day 90 (from screening until the volunteer completes the study) A known allergy to a component of the vaccine, including egg, egg products, chicken proteins, formaldehyde, gentamicin sulfate, or sodium deoxycholate A positive urine pregnancy test in the 24 hours prior to vaccination. (A negative urine pregnancy test is required within the 24 before vaccination for all women who have not had a hysterectomy or are not at least 1 year post-menopausal) A woman who is breastfeeding Any current medical illness that might jeopardize the volunteer's safety or interfere with the interpretation of the study results. These but are not limited to the following: cancer; immunodeficiency; bleeding disorder Any underlying medical condition for which influenza vaccination is recommended: chronic heart or lung conditions, including asthma; metabolic diseases; kidney disease; blood disorder (such as sickle cell anemia); weakened immune systems, including HIV/AIDS Resident of nursing homes and long term care facility Health care worker involved in direct patient care Any current illness requiring daily medication, except for vitamins, contraceptives, topical medications, antihistamines, antacids and other reflux medications, smoking cessation medications, headache medications that do not have antipyretic activity, nasal allergy medications, ophthalmologic and otic medications, psychiatric medications for well-controlled conditions such as depression or anxiety, and thyroxine for stable, inactive hypothyroidism. Volunteers may not take daily oral, nasal, inhaled, or parenteral steroids or non-steroidal anti-inflammatory medications. Medications other than those mentioned above will require approval from the PI, the sponsor, and the medical monitor Any use of antibiotics in the 7 days before enrollment Vital signs that are abnormal and thought by the investigator to increase the risk to the volunteer. Mild elevations or depressions of blood pressure or heart rate may be allowed
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-64.0, Influenza Japanese male and female adults 20 to 64 years of age at time of the first vaccination, inclusive Good general health as assessed by medical history and physical examination Subjects who the investigator believes that they can and will comply with the requirements of the protocol Written informed consent obtained from the subject Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device Females of non-childbearing potential may be enrolled in the study Female of childbearing potential may be enrolled in the study, if she 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 Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period History of previous administration of a novel [H1N1]v vaccine Previous participation in study NCT00742885 Presence of significant acute or chronic, uncontrolled medical or psychiatric illness Presence or evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence of an axillary temperature >= 37.5 °C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Diagnosed with cancer, or treatment for cancer within 3 years Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-39.0, HIV Infections H1N1 Influenza Virus for Step I Confirmed diagnosis of HIV-1 infection Pregnant Between 14 and 35 weeks of gestation Documented platelet count of greater than 50,000 mm3 and an absolute neutrophil count (ANC) of greater than 500 mm3 within 28 days prior to study entry Able to understand and comply with planned study procedures On antiretroviral therapy (ART) as outlined in the treatment guidelines for pregnant HIV-1 infected women. Women must be currently taking ART or should initiate ART either prior to or concomitantly with the first dose of the vaccine. for Step II Received the first dose of influenza A (H1N1) 2009 monovalent vaccine Has a documented platelet count of greater than 50,000 mm3 and an ANC of greater than 500 mm3 within the 28 days prior to Step II entry for Step I Has a known allergy to eggs, egg products, neomycin, or polymyxin Has a history, in the opinion of the site investigator, of severe reactions following previous immunization with seasonal TIV Participation in a novel H1N1 influenza vaccine study in the past 2 years Proven history, by reverse transcription polymerase chain reaction (RT-PCR), of novel influenza H1N1 infection or positive influenza diagnostic test since June 2009 (specificity to H1N1 not required) prior to study entry Received any other live licensed vaccine within 4 weeks or inactivated licensed vaccine within 2 weeks prior to study entry Received a nonlicensed agent (vaccine, drug, biologic, device, blood product, or medication) within 4 weeks prior to vaccination in this study or expects to receive another nonlicensed agent before delivery Acute illness and/or an oral temperature greater than or equal to 100.0 degrees F within 24 hours prior to study entry Use of anti-cancer chemotherapy or radiation therapy within the preceding 36 months of study enrollment or has immunosuppression as a result of an underlying illness or treatment (other than HIV-1 infection) Active neoplastic disease (excluding nonmelanoma skin cancer, human papillomavirus [HPV]-related cervical dysplasia, and cervical intraepithelial neoplasia [CIN] Grades 1, 2, or 3)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Influenza Human immunodeficiency virus (HIV) infection defined as documented by an enzyme-linked immunosorbent assay (ELISA) and confirmed with a Western blot at any time prior to study entry. Serum HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or any Food and Drug Administration (FDA) approved antibody test by a method other than ELISA is acceptable as an alternative confirmatory test Males or non-pregnant females age 18-64, inclusive Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 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, Depo-Provera injections or Implanon implants for at least 30 days following the last vaccination Are medically stable, as determined by the Investigator (based on review of health status, vital signs, medical history, and targeted physical examination. Vital signs must be within normal ranges prior to the first vaccination (heart rate 55-100, blood pressure systolic <160, blood pressure diastolic <90) Receipt of the 2009-2010 seasonal influenza vaccine at least two weeks prior to enrollment in this study Intend to be available for follow-up visits and phone call access through 7 months following receipt of H1N1 vaccine Are able to understand and comply with planned study procedures Subject receiving regular medical follow-up care for HIV Has a documented platelet count of >50,000mm^3 and an absolute neutrophil count (ANC) of >500mm^3 within the 3 months prior to study entry Provide written informed consent prior to initiation of any study procedures Treatment for an opportunistic infection (OI) initiated within 2 weeks prior to enrollment, or have symptoms that have not stabilized Have a known allergy to eggs or other components of the vaccine (including polymyxin, neomycin, and chicken protein) Women who are pregnant or breastfeeding Have a positive urine or serum pregnancy test within 24 hours prior to vaccination Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have a neoplastic disease that will be treated with chemotherapy or radiation, or a history of any hematologic malignancy Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids. For oral or parenteral: prednisone or equivalent (greater than or equal to 2.0 mg/kg per day or greater than or equal to 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months. For inhaled steroids: >800 mcg/day of beclomethasone dipropionate or equivalent within the preceding 6 months. (Nasal and topical steroids are allowed.) Have an uncontrolled major psychiatric diagnosis Have a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study Received an experimental agent (vaccine, drug, biologic, device, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call)
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0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Lower Extremity Surgery Upper Extremity Surgery Post-operative Pain undergoing surgery with a planned popliteal perineural catheter for postoperative analgesia age 18 years or older pregnancy inability to communicate with the investigators and hospital staff incarceration clinical neuropathy in the surgical extremity chronic high-dose opioid use history of opioid abuse
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
|
2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
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0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Pharmacokinetics Healthy, non-smoking female volunteers of childbearing potential aged 18 to 45 years weighing at least 55 kg and within 15% of ideal body weight who are taking oral contraceptives on the advice of their personal health care provider and willing to switch to Ortho-Novum 1/35 Subjects should be either sexually inactive or using a double barrier method of contraception for 14 days before the first dose of study drug and throughout the study Pregnant or lactating Recent (2-year) history or evidence of alcoholism or drug abuse Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C antibody (HCV) History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease Hemoglobin < 12 g/dL Use of any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-gp within 30 days prior to the first dose of Ortho-Novum® 1/35 or expected to require such use
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Non-erosive Gastroesophageal Reflux Disease Functional Dyspepsia Irritable Bowel Syndrome Present with symptoms suggestive of any of the following FGID according to Rome III Classification Non-erosive gastroesophageal reflux disease (NERD) Weekly symptoms of heartburn or acid regurgitation of moderate severity for at least 6 months Functional dyspepsia (FD) Weekly symptoms of epigastric burning sensation, early satiety or postprandial fullness for at least 6 months Irritable bowel syndrome (IBS) Symptoms of abdominal pain or discomfort of at least 3 times a month, in the last 6 months, associated with 2 or more of the following Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Erosive esophagitis (Still eligible for IBS patients) Peptic ulcer (Still eligible for IBS patients after complete ulcer healing) H. pylori positive Organic causes of symptoms, including malignancy, abnormal thyroid function, and inflammatory bowel disease Previous gastric surgery Pregnancy Illiterate Unable to sign the written consent form • Abdominal surgery within one year prior to joining the program
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0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Nicotine Dependence Smoking Sleep Disorders, Intrinsic Age 18-45 Not regularly exercising, defined as exercising fewer than three times per week and for no more than 20 minutes each time Free of medical illnesses (need to be cleared by a physician as able to exercise at 60% maximum heart rate (MHR)) Currently meeting DSM-IV for nicotine dependence (No Current or Past history of any other psychiatric disorder) Regularly smoking at least 08 cigarettes per day for at least 12 consecutive months, not attempted to quit smoking in the previous month, and not currently taking medication for smoking cessation Currently displaying carbon monoxide breath readings >10 and urine cotinine levels >3 Habitual bedtime between 9:30 p.m. and 1:30 a.m Body Mass Index (BMI) less than 40 Unable to exercise Currently diagnosed or treated for any psychiatric disorder; treatment with psychotropic medication will be considered on a case by case basis History or active treatment or any treatment in past year for any mood or psychotic disorder Current or past diagnosis of a sleep disorder Currently taking sleep medications or other medications known to alter sleep architecture Currently doing shift work or working at night History of travel across time zones in the past month For women of child bearing potential: pregnant or actively trying to become pregnant Parent of a child under two years of age Diagnosis of Sleep Apnea
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, HIV-1 Infections Historical Cohort: HIV-infected participant treated with antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of Kaiser Permanente (KP) between 1 January 2000 and 12 October 2007 (date of market authorization for raltegravir in USA) Raltegravir Cohort: HIV-infected participant treated with raltegravir in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007 Concurrent Cohort: HIV-infected participant treated with a new non-raltegravir antiretroviral therapy in the course of ordinary clinical practice at the clinics and medical centers of KP on or after 12 October 2007 All participants must have at least one year of continuous membership with KP prior to date when the participant received the first dispensed prescription for study drug (index date) to allow for the assessment of medical and treatment history Less than 18 years of age Do not receive their medications through the KP pharmacy system Do not receive their laboratory examinations through the KP system Participating in the raltegravir phase III or expanded access program
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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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 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Pregnancy During Breastfeeding Lactational Amenorrhea Method All women who delivers in the obstetric intent to breast-feed Eligible participants should have been planning of birth spacing Women refusal to participate in the study Women planned to use a method of contraception other than LAM Anticipation of difficulty of subsequent communication with the woman
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0
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