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A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 3.0-999.0, Influenza Healthy subjects more than 3 years 2. Guardian and/or subjects aged at least 10 subjects can be informed consent, and sign a written Informed Consent Form. 3. Subjects, Guardians and his family can obey the demands of the scheme . 4. Axillary temperature less than 37℃ Subjects with flu or infected with flu within 3 months. 2. Subjects have a vaccine allergies, allergic to any kind of composition in experimental vaccine, such as eggs, ovalbumin etc. 3. Subjects have serious side effects to vaccine, such as allergy, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain. 4. Subjects have symptoms of acute infection within a week. 5. Subjects have autoimmune disease or immune function defect, Subjects have used immunosuppressive therapy, cytotoxic treatment or inhaled corticosteroids in the past 6 months. 6. Subjects have congenital malformations, developmental disorder or serious chronic diseases( such as Down's syndrome, diabetes, Sickle cell anemia or nerve system disease) 7. Subjects have asthma unstable that need emergency treatment, hospitalization, intubation, oral or intravenous corticosteroid in the past 2 years. 8. Subjects have medical history or family history of convulsions, seizures, encephalopathy and psychiatric disease. 9. Alienia, functional asplenia, and alienia or splenectomy in any situation. 10. Serious neurological disorders such as Green Barry syndrome. 11. Subjects have received blood products or immunoglobulin products within 3 months before experimental vaccine inoculated. 12. Subjects have received other study drug in the past month or received live vaccine, subunit vaccine or inactivated vaccine. 13. The indicators of blood test or urine test do not conform to the criteria. 14. Subjects have received allergy treatment in in the past 14 days. 15. Subjects are receiving anti-tuberculosis treatment. 16. Subjects have inoculated flu vaccine in the flu reason. 17. Axillary temperature is more than 37℃ before vaccination. 18. Subjects are pregnant or plan to become pregnant 19. Subjects are participate in other clinical trials. 20. Any factors unsuitable for clinical trail at the discretion of the investigator | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Ipsilateral Shoulder Pain Cesarean Presence of post-operative ISP, VAS >5/10 American Society of Anesthesiologists Class 1 No allergy to lidocaine American Society of Anesthesiologists Class 4 or 5 Allergy to lidocaine Nasal pathology (e.g., deviated septum) Patients who receive sedatives during cesarean Bleeding diathesis Any patient who the PI feels will be unable to comply with all protocol related procedures Shoulder pain prior to cesarean | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-125.0, Heart Failure Patients hospitalized with congestive heart failure Patients who do not have congestive heart failure Patients under age of 18 Patients not admitted as inpatients | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Community-acquired Pneumonia, Influenza, COVID-19 REMAP-CAP 1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with: 1. symptoms or signs or both that are consistent with lower respiratory tract infection AND 2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate) 2. Up to 48 hours after ICU admission, receiving organ support with one or more of: 1. Non-invasive or Invasive ventilatory support; 2. Receiving infusion of vasopressor or inotropes or both Healthcare-associated pneumonia: 1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days 2. Resident of a nursing home or long term care facility 2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 3. Previous participation in this REMAP within the last 90 days REMAP-COVID 1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection. REMAP-COVID Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 2. Patient is expected to be discharged from hospital today or tomorrow 3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection. 4. Previous participation in this REMAP within the last 90 days Each domain may have additional criteria. Refer to the study website for more information (www.remapcap.org) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Healthy Volunteers Elderly Age ≥65 year old Able to give informed consent Necessity to receive influenza seasonal vaccination in 2013-2015 Availability for the duration of the study and willingness to attend all scheduled visits Hemoglobin value ≥100 g/l , Leukocytes ≥3.5 G/L, Platelets count ≥100 G/l at the time of screening, or determined within 8 weeks before screening in the course of regular medical examination and validated by the medical doctor. Solid-organ transplant recipients Age ≥18 year old Solid organ transplantation >3 months before vaccination Stable patient followed at the outpatient clinic of the Transplantation Center Able to give informed consent. Necessity to receive influenza seasonal vaccination. Availability for the duration of the study and willingness to attend all scheduled visits Previous life-threatening reaction to influenza vaccine (i.e. Guillain-Barre Syndrome) Ongoing therapy for rejection Febrile illness in the past two weeks Contraindication against seasonal flu vaccination Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study vaccine, or planned use during the study period and safety follow-up Immunodeficiency or chronic administration (defined as more than 14 consecutive days) of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed) Hypersensitivity to the active substances, to any of the excipients, to eggs, chicken proteins, neomycin, formaldehyde and octoxinol 9 Acute disease at the time of enrollment [Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., temperature <38°C] An unstable chronic condition (unstable chronic renal failure, unstable diabetes, unstable chronic cardiac condition, uncontrolled asthma, etc.) Receipt of blood-derived products (immunoglobulin; plasma) within 120 days prior to enrollment | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Desmoplastic Melanoma A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per 1.1 Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient's chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1) Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration Patients must not have received prior systemic treatment for this melanoma Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology for Adverse Events [CTCAE] 4.0) prior to registration Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to registration) Platelets >= 50,000/mcl (obtained within 28 days prior to registration) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-21.0, Pain Sleep Soccer players Aged between 16 and 21 years Male Train at least 5 times a week No complaints of musculoskeletal pain or history of muscle injuries in the past six months Hired at the same club with the same demand for training and competitions will be observed vascular problems Allergy to cold Surgery of the lower limbs in the past six months Athletes in viral states (such as colds or flu) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 25.0-999.0, Menopause Migraine years old or above Healthy women Those with history of present illness Past history of significant neurological and psychiatric disorders or MRI contraindication | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 55.0-999.0, Respiratory Syncytial Virus Infections (Main study): 1. Male and female subjects, ≥ 55 years of age. 2. Prior to performance of any trial specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject, and has signed the Health Insurance Portability and Accountability Act (HIPAA) authorization form. 3. Subjects without symptomatic cardiopulmonary and/or metabolic disease. Note that subjects who have any active symptoms related to cardiac and/or pulmonary and/or metabolic disease (including e.g. uncontrolled asthma, angina pectoris, hyperglycaemia or other episodic symptoms), or who receive ongoing therapy to control current, active symptoms, are not eligible. Subjects on stable treatment (no change in ≥ 1 month) for previous and controlled symptoms or conditions are eligible. The following are examples of subjects who may bear cardiopulmonary or metabolic diagnoses but who would remain eligible Subjects on stable (no change in ≥ 1 month) therapy for findings (e.g. hypertension, hyperlipidemia) which are not associated with current symptoms or disability Subjects with type II diabetes mellitus are considered eligible as long as they are stable on oral antidiabetics and have either a documented glycated hemoglobin (HbA1c) of ≤ 8 % within three months prior to trial participation or confirmation of controlled blood glucose level must be obtained at the SCR (screening) visit by a lab test Subjects who receive short term treatment for temporary conditions Other clinically insignificant findings not deemed to be associated with increased risk for respiratory viral infections as determined by the investigator. 4. Able to comply with trial requirements; including access to transportation for trial visits. 5. Body mass index (BMI) ≥ 18.5 and ≤ 39.9 BMI formula for pounds and inches: BMI = (bodyweight in pounds) * 703 (bodyheight in inches)2 6. Women of childbearing potential (WOCBP) must have used an acceptable method of contraception for at least 30 days prior to the first vaccination, must agree to use an acceptable method of contraception (as defined in Section 8.2.11) during the trial, and must avoid becoming pregnant for at least 28 days after the last vaccination. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination 7. Not clinically significant laboratory values as defined in the protocol, excluding any Grade ≥ 3 toxicity. 8. Negative human immunodeficiency virus antibody test (anti-HIV), negative hepatitis B surface antigen (HBsAG) and negative antibody test to hepatitis C virus. 9. Electrocardiogram (ECG) without clinically significant acute findings (e.g. findings suggestive of current ischemia, ventricular arrhythmias, congestive heart failure and ventricular hypertrophy) (Main Study): 1. Pregnant or breast-feeding women. 2. Uncontrolled serious infection, i.e. not responding to antimicrobial therapy. 3. History or current clinical manifestation of any serious medical condition, which in the opinion of the investigator would compromise the safety of the subject or would limit the subject's ability to complete the trial History of cerebrovascular disorders, including stroke. Patients with history of transient ischaemic attack (TIA) ≥ 1 year prior to trial participation remain eligible History of myocardial infarction within ≤ 1 year prior to trial participation, current clinical manifestation of angina pectoris, current clinical manifestation of congestive heart failure ≥ New York Heart Association (NYHA) Grade II, uncontrolled high blood pressure defined as systolic blood pressure ≥ 150 mmHg and/or diastolic ≥ 100 mmHg within the last 2 months. 4. History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded. Persons with rheumatoid arthritis not requiring immunomodulatory and/or immunosuppressant treatment are not excluded. 5. Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I. 6. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision at least 6 months ago that is considered to have achieved cure. Subjects with history of skin cancer should not be vaccinated at the previous tumor site. 7. Clinically significant mental disorder, not adequately controlled by medical treatment. 8. Active or recent (within the time period of six months before trial participation) history of chronic alcohol abuse and/or intravenous and/or nasal drug abuse. 9. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. tris(hydroxymethyl)-amino methane, chicken embryo fibroblast proteins, gentamycin. 10. Known allergy to eggs or aminoglycosides. 11. History of anaphylaxis or severe allergic reaction to any vaccine. 12. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after trial vaccination. 13. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after trial vaccination. 14. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted. 15. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from three months prior to first administration of the trial vaccination and ending at the last visit of the active trial phase. 16. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first trial vaccination, or planned administration of such a drug between participation in the trial and until 4 weeks after last trial vaccination. 17. Previous or planned vaccination with a RSV vaccine/vaccine candidate. 18. Clinical trial personnel working on the current trial. (Substudy): 1. Prior to performance of any booster substudy specific procedures, the subject has read, signed and dated an informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject. 2. Subject has completed all vaccinations of the main trial according to protocol (Substudy): 1. Any condition that, in the opinion of the investigator, makes it unsafe for the subject to receive a further vaccination. 2. Pregnancy. 3. An anaphylactic reaction following the administration of any vaccine(s). 4. Clinical need for concomitant or ancillary therapy not permitted in the trial as outlined in Protocol Section 8.2.2. 5. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after booster vaccination. 6. Having received any vaccinations or planned vaccinations with an inactivated vaccine within 14 days prior to or after booster vaccination. 7. Chronic systemic administration (defined as more than 14 days) of > 5 mg prednisone (or equivalent)/day or any other immune-modifying drugs during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase. The use of topical, inhaled, ophthalmic and nasal glucocorticoids is permitted. 8. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the booster vaccine and ending at the last visit of the booster active trial phase. 9. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the booster vaccination, or planned administration of such a drug during participation in the booster substudy and until 4 weeks after booster vaccination. 10. Subject's request to discontinue 11. Subject's refusal to receive booster vaccination. 12. Subject unwilling or unable to comply with trial requirements. Any reason that, in the opinion of the investigator contradicts administration of the booster vaccination or otherwise requires early discontinuation of a subject | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Malaria under 5years will stay in the community for 10years chronic diseases | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Tracheotomised Children Anxiety of Parents Depression of Parents Families whose child Has been tracheotomised before the age of 1 year between 2000 and 2012 Came out of hospital with a tracheotomy tube Is or has been followed by one of three centers Children decannulated before hospital discharge Death before the start of the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 3.0-999.0, Influenza Aged 3 to <9 years or adult aged ≥ 18 years on the day of first study vaccination (study product administration) Informed consent form had been signed and dated by participants ≥ 18 years of age Assent form had been signed and dated by participants 7 to <9 years of age, and informed consent form (ICF) has been signed and dated by parent(s) or guardian(s) for participants 3 to <9 years of age Participant and parent/guardian (of participants 3 to <9 years of age) were able to attend all scheduled visits and to comply with all trial procedures Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile Participation at the time of study enrollment (or in the 30 days preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 30 days preceding the first trial vaccination, or planned receipt of any vaccine before Visit 2 for participants receiving 1 dose of influenza vaccine or Visit 3 for participants receiving 2 doses of influenza vaccine Previous vaccination against influenza (in the 2016-2017 influenza season) with either the trial vaccine or another vaccine Receipt of immune globulins, blood, or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding contraindicating intramuscular vaccination Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Vaccine, Influenza Parents of guardians of children aged 2-4 on 31st August 2016 (i.e. born September 1st 2011 to August 31st 2014) who receive the flu vaccine at the GP Parents must be aged 18 or over Parents must be fluent in English | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Gastric Adenocarcinoma Esophageal Squamous Cell Carcinoma Nasopharyngeal Carcinoma Head and Neck Squamous Cell Carcinoma "Inclusion Subjects may be entered in the study only if they meet all of the following 1. Fully understand the study and signed the Informed Consent Form (ICF) voluntarily; 2. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet the following conditions (not applicable to cohort 5, 6, 7, and 8): Subjects with gastric adenocarcinoma must have received at least one line of anti-tumor treatment for advanced gastric adenocarcinoma and have documented tumor progression or be intolerable to the current available chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant chemotherapy of radical operation are eligible to this study; Subjects with esophageal squamous cell carcinoma must have received at least one line of treatment for advanced esophageal squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to the current chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant therapy (including but not limited to chemotherapy or radio-chemotherapy) of radical operation are eligible to this study; Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma who have received at least one line of treatment for advanced nasopharyngeal carcinoma or head and neck squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to other current chemotherapy regimens. Subjects with recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant radio-chemotherapy of radical operation are eligible to this study (only applies for Version 4.1 and the previous ones); while for the working protocol version 5.0, subjects with nasopharyngeal carcinoma can be enrolled only if they meet the following subjects having received at least two lines of treatment for advanced nasopharyngeal carcinoma (including but not limited to anticancer drug treatment and radio-chemotherapy), who are confirmed to have tumor progression or be intolerable to other current chemotherapy regimens; adjuvant or neoadjuvant radio-chemotherapy after radical surgery can be considered as one line of treatment if tumor recurrence or metastasis occurred within 6 months after the end of the radio-chemotherapy. 3. At least one measurable lesion (according to 1.1); Note: Any lesion which received radiotherapy treatment previously cannot be regarded as a target lesion, unless that it has definitely progressed after radiotherapy. 4. Agree to provide archived tumor tissue specimens or have biopsy to collect tumor tissues for PD-L1 IHC measurement in the central laboratory; 5. Males or females aged between 18 and 75 years old; 6. ECOG score of 0-1; 7. Life expectancy ≥ 3 months; 8. The results of laboratory tests performed within 7 days prior to enrollment must meet the following 1. Neutrophils ≥ 1.5×109/L (not applicable to cohort 5, 6, 7, and 8); 2. Platelets ≥ 75×109/L (not applicable to cohort 5, 6, 7, and 8); 3. Hemoglobin ≥ 90 g/L (without receiving infusion of concentrated red blood cells within 2 weeks); 4. Serum creatinine ≤ 1.5× upper limit of normal (ULN), or creatinine clearance > 50 mL/min (not applicable to cohort 5, 6, 7, and 8); 5. Serum total bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN are acceptable for subjects with Gilbert syndrome); 6. Both AST and ALT ≤ 2.5×ULN; ALT and AST ≤ 5×ULN are acceptable for subjects with liver metastasis; 9. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 60 days after the end of study treatment. Women of childbearing potential are defined as women with sexual maturity, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) (not applicable to cohort 5, 6, 7, and 8). Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Other special for cohort 5, 6, 7, and 8. 1. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet any of the following conditions: 1. Subjects who have not received any systematic treatment. 2. Subjects who have received any neoadjuvant chemotherapy, adjuvant chemotherapy for the purpose of curing must experience a period for at least 6 months from the end of the last chemotherapy to tumor progression. 3. Subjects with head and neck squamous cell carcinoma must have received radiotherapy for the purpose of curing, and the period from the end of radiotherapy to tumor progression must be at least 1 year. 4. For subjects with gastric carcinoma, Her2 negative is required. HER2 positive is defined as IHC 3+ or IHC 2+ combined with ISH+, and ISH positive is defined as the ratio of the number of HER2 gene copies to the number of CEP17 signals ≥ 2.0. 2. Results of laboratory test conducted within 7 days before enrollment must meet the following 1. Neutrophils ≥ 2×109/L; WBC count ≥ 4×109L and < 15×109/L 2. Platelets ≥ 100×109/L; 3. Hemoglobin ≥ 90 g/L (no infusion of concentrated red blood cells within 2 weeks); 4. Creatinine clearance rate > 60 mL/min, based on the predicted value of Cockcroft-Gault glomerular filtration rate: (140 age) × (weight, kg) × (0.85, if females) 72× (serum creatinine, mg/dL) Or: (140 age) × (weight, kg) × (0.85, if females) 0.818 × (serum creatinine, μmol/L) 5. Serum total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN are acceptable for subjects with Gilbert syndrome); 6. INR and aPTT ≤ 1.5 × ULN, applies only to subjects who have not received anticoagulation; and for subjects who are receiving anticoagulation, the dose for anticoagulation must be stable. 3. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 6 months after the end of chemotherapy or 60 days after the end of study treatment (whichever comes last). Women of childbearing potential are defined as women with sexual maturities, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) . Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Subjects fulfilling any of the following conditions cannot be enrolled in the study: 1. Known hypersensitivity to citric acid monohydrate, dihydrate sodium citrate, mannitol or polysorbate (components of the investigational drug); 2. Anti-tumor treatment with cytotoxic drugs, biological drugs (e.g. monoclonal antibody), immunotherapy (e.g. interleukin 2 or interferon), or other investigational drugs within 4 weeks prior to enrollment; 3. Tyrosine kinase inhibitor treatment within 2 weeks prior to enrollment; 4. Radiotherapy within 4 weeks prior to enrollment, or radioactive drugs within 8 weeks prior to enrollment. However, patients receiving local palliative radiotherapy for bone metastasis lesions can be included; 5. Subjects with any major surgical operation within 4 weeks prior to enrollment or who have not completely recovered from the prior operation (for the definition of major surgical operation, please refer to the Level 3 and Level 4 operations stipulated in the Management of Clinical Application of Medical Technology enforced on May 1, 2009); 6. Toxicity due to any previous anticancer treatment has not recovered to CTCAE Grade 0-1, excluding the following conditions: 1. Alopecia; 2. Pigmentation; 3. Peripheral nerve toxicity recovered to < CTCAE Grade 2 (not applicable to cohort 5, 6, 7, and 8, subjects are not eligible if peripheral neurotoxicity does not restore to normal); 4. Long-term toxicity related to radiotherapy, which will not fully recover as judged by the investigator. 7. Central nervous system metastasis with clinical symptoms (e.g. brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. Subjects with prior treatment for brain or meningeal metastasis can be included if they have remained stable clinically for at least 2 months and systemic hormone treatment (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) has been discontinued for more than 4 weeks; 8. Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma, who are found to have necrotic lesions by examination within 4 weeks prior to enrollment, for which there is a potential risk of massive hemorrhage as judged by the investigator; 9. Previous or other concurrent malignant tumors (expect for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors which were effectively controlled without treatment over the past 5 years); 10. Any active autoimmune disease or history of any autoimmune disease (including but are not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism. Patients with vitiligo or asthma (in childhood) which was completely resolved and without need of any intervention in adulthood can be included. However, subjects with asthma which needs bronchodilator for medical intervention cannot be included); 11. Previous treatments with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody which acts on T-cell co-stimulatory or checkpoint pathway); 12. Subjects diagnosed with active tuberculosis (TB), who are receiving anti-tuberculosis therapy or used to have anti-tuberculosis therapy within 1 year prior to screening; 13. Concomitant diseases requiring long-term treatment with immunosuppressive drugs, or corticosteroids at an effective immunosuppressive dose (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) for systemic or local treatment purpose; 14. Subjects who have received any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 15. Pregnant or lactating women 16. Positive test for HIV; 17. Positive test for HBsAg, with HBV DNA copies detected as positive (quantitative measurements ≥ 1000 cps/mL); 18. Positive test for chronic Hepatitis C in blood screening test (HCV antibody positive); Any other clinical significant disease or condition, which as evaluated by the investigator, may affect the protocol compliance, signing of inform consent form (ICF), or not suitable to participate into this clinical trial | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Depressive Mood week in-house-rehab at an acute geriatric unit ability to take part in assessments understanding German language Informed Consent anti-depressive medication shorter than 4 weeks before enrollment In-house rehab < 14 days advanced stage of dementia | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-49.0, Avian Influenza H1N1 Influenza Influenza Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 18 to 49 years old, inclusive. 4. Are in good health*. *As determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription 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 deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject ), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.4 degrees F. 6. Pulse is 50 to 115 bpm, inclusive. 7. Systolic blood pressure is 85 to 150 mm Hg, inclusive. 8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive. 9. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour. 10. Women of childbearing potential* must use an acceptable contraception method** from 30 days before first study vaccination until 60 days after last study vaccination. *Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal. **Includes, but is not limited to, non-male sexual relationships abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination Have an acute illness*, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation*. *Including acute or chronic medical disease or condition, defined as persisting for at least 90 days that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study. 3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. 4. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy. 5. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. 6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccines. 7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines. 8. Have a personal or family history of narcolepsy. 9. Have a history of Guillain-Barré syndrome. 10. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. 11. Have a history of a potentially immune-mediated medical condition. 12. Have a history of alcohol or drug abuse within 5 years prior to study vaccination. 13. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 14. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination. 15. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. 16. Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as >840 mcg/day of beclomethasone dipropionate CFC or equivalent. 17. Received licensed live vaccine within 30 days prior to the first study vaccination, or plans to receive licensed live vaccine within 30 days before or after each study vaccination. 18. Received licensed inactivated vaccine within 14 days prior to the first study vaccination, or plans to receive licensed inactivated vaccine within 14 days before or after each study vaccination. 19. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination. 20. Received an experimental agent* within 30 days prior to the first study vaccination, or expects to receive an experimental agent** during the 13-month study-reporting period. *Including vaccine, drug, biologic, device, blood product, or medication. **Other than from participation in this study. 21. Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the 13-month study-reporting period. *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 22. Prior participation in a clinical trial of influenza A/H7 vaccine* or have a history of influenza A/H7 virus actual or potential exposure or infection prior to the first study vaccination. *And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients. 23. Prior participation in a clinical trial of influenza A/H3N2v vaccine* or have a history of influenza A/H3N2v virus actual or potential exposure or infection prior to the first study vaccination. *And assigned to a group receiving influenza A/H3N2v vaccine, does not apply to documented placebo recipients. 24. Occupational exposure to or substantial direct physical contact* with birds in the past year or during the 28 days after each study vaccination. *Casual contact with birds at petting zoos or county or state fairs or having pet birds does not subjects from study participation. 25. Occupational exposure to or substantial direct physical contact* with pigs in the past year or during the 28 days after each study vaccination. *Casual contact with pigs at petting zoos or county or state fairs does not subjects from study participation. 26. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination. 27. Plan to travel outside the US (continental US, Hawaii, and Alaska) within 28 days after each study vaccination. 28. Blood donation or planned blood donation within 30 days before enrollment until 30 days after the last blood draw for this study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Respiratory Infections Antibiotics General practitioners working in primary care Patients with suspected respiratory tract infection Patients that have already started an antibiotic | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Vaccination undergraduate and graduate students at the University of Toronto's Leslie Dan Faculty of Pharmacy undergoing flu vaccination less than 18 years of age or prior participation in the trial | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Primary Cutaneous Vasculitis Cutaneous Polyarteritis Nodosa IgA Vasculitis Henoch-Schönlein Purpura Patients with primary skin vasculitis, not associated with any significant extra-cutaneous involvement that would require specific immunosuppressive therapy. Eligible patients will have a diagnosis of either Isolated cutaneous small vessel (SV) or medium-sized vessel (MV) vasculitis or cutaneous polyarteritis nodosa (PAN) IgA vasculitis (IgA, formerly Henoch-Schönlein purpura), without active and/or progressing renal involvement (stable glomerular filtration rate (GFR) >60 ml/min; absence of, or mild-and-stable microscopic hematuria without red blood cell casts; absence of, or mild-and-stable proteinuria (<1g/24 hours); not requiring systemic immunosuppressive therapy). These conditions, when skin-limited, are all currently treated in similar manners in practice. Mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia (Hb ≥ 10 g/dL) will be allowed. 2. The diagnosis of vasculitis must have been confirmed by skin biopsy prior to enrollment (earlier, at diagnosis, and/or just prior to enrollment) that has included an immunofluorescence study (in the case of small vessel vasculitis). 3. Patients must have active cutaneous vasculitis lasting for at least 1 month continuously and/or have had 2 or more flares over the six months preceding enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis). 4. Patients must have active / ongoing cutaneous vasculitis lesions at the time of enrollment (post-inflammatory lesions such as hyperpigmentation or healing ulceration(s) are not to be considered active vasculitis). 5. Patients may have a contra-indication to one of the study drug or have been treated prior to enrollment with one of the study medications but failed to respond to it (according to the study definitions of failure and if they have been on the drug at the target dose or higher for 3 months or longer) or had to stop it because of an adverse event. Such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of such patients enrolled directly in stage 2 will be capped at 10 (10% of the total recruitment target). 6. Patients may have received systemic glucocorticoids for their cutaneous vasculitis before enrollment. For the patients on prednisone at the time of enrollment, prednisone should be stopped within a maximum of 6 weeks after enrollment and initiation of the study drug, following a pre-defined tapering schedule. Patients on long-term, low and stable dose of glucocorticoids (≤5 mg/day prednisone-equivalent) for other conditions (e.g., asthma or adrenal insufficiency) can be enrolled if the likelihood of requiring a dose increase for this other condition is low during the 6 month study period (these patients will remain on that low and stable dose during the study period, with the option to receive one short course of prednisone at higher doses for skin vasculitis flare during the first 3 months of the study period, like any other patients enrolled). 7. Participant age 18 years or greater Presence of significant extra-cutaneous manifestations suggestive of a systemic vasculitis or more diffuse condition. The presence of mild arthralgias, myalgias, peripheral limb edema, fatigue, weight loss ≤6 lbs or 3 kg within past 3 months, low-grade fever, and mild anemia [Hb ≥ 10 g/dL] are not Mild and stable microscopic hematuria without RBC casts and/or mild and stable proteinuria (<1g/24 hours) are not These latter patients must not require systemic immunosuppressive therapy because of possible renal involvement and their GFR must be >60 ml/min. 2. Known systemic and/or non-skin-isolated vasculitis, such as granulomatosis with polyangiitis, eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, systemic polyarteritis nodosa, central nervous system vasculitis and patients with detectable antineutrophil cytoplasmic antibody (ANCA) by immunofluorescence or ELISA. 3. Hypocomplementemic urticarial vasculitis, cryoglobulinemic vasculitis, and other known secondary skin vasculitides such as those secondary to systemic lupus erythematosus, Sjögren syndrome, another auto-immune condition, a cancer, a hematological disorder, an ongoing active infection, or an ongoing medication. Investigators should consider such underlying diagnoses and perform and interpret appropriate laboratory work-up where indicated based on clinical presentation. 4. History of significant intolerance, allergy or serious adverse events to any of the study medications: such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs. The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%). 5. Patients who have contra-indications to two or three of the study drugs (azathioprine, colchicine, or dapsone), or have been treated prior to enrollment with two or three of the study drugs but failed to respond to them, or had to stop two or three of them because of adverse events. 6. Deficit in glucose-6-phosphate dehydrogenase (G6PD) or history of hemolytic anemia (all patients must be tested for G6PD at the screening visit to assess for their eligibility): such patients can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (azathioprine or colchicine). The number of patients enrolled directly in stage 2 of the study will be capped at 10 (10%). 7. Low or absent thiopurine methyltransferase (TPMT) activity (if known, not a requirement for study entry): Patients known to have low or absent TPMT can be enrolled directly in the second stage of the study and be randomized to receive one of the two other study drugs (dapsone or colchicine). 8. Evidence of significant hepatic insufficiency or liver function tests > 2 times the upper limit of normal. 9. Evidence of significant renal insufficiency or creatinine clearance < 60 mL/min. 10. Evidence of significant or symptomatic anemia or Hb < 10 g/dL. 11. Comorbid condition that has moderate or high likelihood of requiring intermittent courses of prednisone within the study period, according to the investigator (e.g. chronic obstructive pulmonary disease (COPD), unstable or severe asthma). 12. Active cancer or history of malignancy within the previous 5 years (patient in remission of a cancer >5 years, or with non-metastatic prostate cancer or treated basal or squamous cell carcinoma of the skin can be enrolled). 13. Active uncontrolled or serious infection that may compromise or contra-indicate the use of the study medications. 14. Patient unable to consent. 15. Pregnant or lactating women | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 30.0-999.0, Hepatitis E Criteria(all volunteers): 1. Aged over 30 years old on the day of enrollment 2. Axillary temperature is below than 37.0 ℃. 3. No administration of HEV vaccine before the study 4. Judged as healthy and eligible for vaccination by the investigators through a selfreported medical history and some physical examinations. 5. Able to understand this study information and willing to comply with all study requirements. 6. Willing to participate in this study and sign informed consent form. 7. Negative serological markers for hepatitis E Criteria(experiment group): 1. ALT < 1.5×ULN 2. No spleen swelling,no cirrhosis and no hepatocellular carcinoma Criteria(control group): 1. HBsAg(-) With clinical evidence of malignant tumor 2. History of severe cardio-cerebrovascular disease 3. Administration of hepatotoxicity drugs before or during the study 4. Pregnancy,breast-feeding or plan to be pregnant in 7 months later 5. Participated in any other clinical trial during the study period. 6. Use of any investigational product or non-registered product (drug or vaccine)within 30 days preceding the first dose of the study vaccine or plan to use during the study period. 7. Received immunosuppressed, immunoregulation therapy or corticosteroid systemic therapy for more than 14 days in the 6 months before entry, except local treatment. 8. Administration of any immunoglobulin or blood products within 3 months preceding the first dose of the study vaccine,or plan to use during the study period. 9. Administration of any inactivated vaccines within 14 days preceding the first dose of the study or attenuated live vaccines within 21 days preceding the first dose of the study. 10. Had a fever (axillary temperature over 38°C) within 3 days or acute illness requiring systemic antibiotics or antiviral treatment within 5 days before vaccination. 11. Immunodeficiency (such as HIV carriers), primary disease of important organs, malignant tumor, or any immune disease (such as systemic lupus erythematosus, arthritis pauperum, splenectomy or functional asplenia or other disease which might affect immune response). 12. History of allergic disease or history of serious adverse events occurring after vaccination, i.e., allergy,urticaria, dyspnea, angioneurotic edema or abdominal pain. 13. Allergic history to any component of this vaccine. 14. Asthma that needed emergency treatment, hospitalization, oral or intravenous corticosteroid to keep stable in the past two years. 15. Combining another severe internal medicine disease(such as severe hypertension, cardiopathy,diabetes and hyperthyroidism) 16. Anomal coagulation function or coagulopathy diagnosed by doctor 17. Epilepsy(not including alcohol epilepsy within 3 years prior to abstinence and simple epilepsy that do without curing within 3 years prior to the study ) 18. Anomal psychology or mind affecting the individual's ability to obey the study requie 19. Other medical, psychological, social or occupational factors that, according to the investigators' judgment,might affect the individual's ability to obey the protocol or sign the informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, eHealth For the participants 1. The participant has a minimum age of 65 years. 2. The participant is living independently or semi-independently at home, service flat or care home. 3. The participant has no subjective memory concern as reported by the participant, informant, or clinician. 4. The participant has a normal brain function documented by scoring above 27 on the MMSE, above 26 on the MOCA and has a score of 0 for the CDR. 5. In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator. 6. The participant is fluent in written and verbal Dutch. For the participants with 1. The participant has a minimum age of 65 years. 2. The participant is living independently or semi-independently at home, service flat or care home. 3. In the opinion of the investigator, the participant is in stable medical condition and willing and able to perform study procedures in the opinion of the investigator. 4. The participant is fluent in written and verbal Dutch. 5. For MCI: MCI patients, at baseline, are diagnosed applying Petersen's diagnostic i.e., (1) cognitive complaint, preferably corroborated by an informant; (2) objective cognitive impairment, quantified as performance of more than 1.5 SD below the appropriate mean on the neuropsychological subtests (z-score below -1.5); (3) largely normal general cognitive functioning; (4) essentially intact activities of daily living (ADL) (basic and instrumental activities of daily living (iADL) were determined by a clinical interview with the patient and an informant); and (5) not demented. 6. For AD:Probable AD according to the National Institute on Aging/Alzheimer's Association Diagnostic Guidelines | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc" | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 21.0-999.0, Influenza-Like Illness Influenza Adult patients 21 years of age or older Presenting to the BMC main ED or Urgent Care area with influenza-like illness Physician ordered an influenza A/B diagnostic test Previously enrolled in the study Any Influenza test result already available at the time approached by the ED RA Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test Unable to give informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Coverage Rate of Vaccination for Influenza pregnant women older than 18 vaccination records signatetd letter of agreement younger than 18 | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Breastcancer Age > 18 years HER2/neu+ over-expressing breast cancer (IHC 3+ or FISH ≥2.0) Patients who are receiving adjuvant trastuzumab as standard of care treatment Completion of breast cancer therapy (i.e., surgery, radiation, and chemotherapy as appropriate per standard of care for patients' specific cancer) to trastuzumab (Patients on oral hormonal therapy as part of their adjuvant breast cancer treatment will be maintained on their regimens.) Enrollment must occur so that patients' trastuzumab treatment and vaccine schedule overlap for all 6 vaccinations and so that first vaccination occurs after a standard of care Multiple Gated Acquisition Scan (MUGA) ECOG performance status (PS) 0-1 Clinically cancer-free (no evidence of disease; excluding +CTC) If the patient is of childbearing potential, she must be willing to practice adequate contraception through the study treatment period and for 2 months after completion of the injection sites Ability to understand and the willingness to sign a written informed consent document Clinical and/or radiographic evidence of residual or persistent breast cancer Receiving immunosuppressive therapy to methotrexate or steroids (note: the use of prednisone, or equivalent, <2.0mg/day, is allowed) Tbili >1.8, creatinin >2, hemoglobin <10, platelets <100,000/mm³, WBC <2,000 Active pulmonary disease requiring medication to multiple inhalers Patients may not be receiving any other investigational agents (except with permission of the Lead Principal Investigator) Pregnant or are nursing History of autoimmune disease (patients with vitiligo not excluded) HIV positive Previous or concomitant malignancies at other sites, except effectively treated non- melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured Other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-49.0, Influenza Otherwise healthy, 6 mo-49 year-old volunteers. 2. Willing to complete the informed consent process (including assent for minors 7-17 years of age). 3. Availability for follow-up for the planned duration of the study. 4. For parents of children 6 months years of age: Willing to participate in the study annually for up to 5 years (if yes, consider for annual return groups). 5. Acceptable medical history by review of inclusion/ and vital signs. 6. Influenza vaccine-naive or only one prior season of flu immunization with IIV (does not apply to Groups F and G) Prior off-study vaccination with the current year's seasonal influenza vaccine 2. Receipt of LAIV in the prior season (does not apply to Groups F and G) 3. Received flu immunizations in 2 or more prior flu seasons (does not apply to Groups F and G) 4. Allergy to egg or egg products, or to vaccine components, (including gentamicin, gelatin, arginine or MSG if given LAIV4) 5. Life-threatening reactions to previous influenza vaccinations 6. Asthma in adults. Children aged 2 through 4 years who have asthma or who have had a wheezing episode noted in the medical record within the past 12 months, or for whom parents report that a health care provider stated that they had wheezing or asthma within the last 12 months [If yes, not eligible for LAIV Groups A, B, C, & F]. 7. Active systemic or serious concurrent illness, including febrile illness on the day of vaccination 8. History of immunodeficiency (including HIV infection) 9. For children or adolescents through 17 years of age,receiving aspirin therapy or aspirin-containing products [If yes, not eligible for LAIV Groups A, B, C, and F]. 10. Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol. 11. Blood pressure >150 systolic or >95 diastolic at first study visit and the day of vaccination (for children 12 yrs and older, and adults). 12. Hospitalization in the past year for congestive heart failure or emphysema. 13. Chronic Hepatitis B or C 14. Recent or current use of immunosuppressive medication, including systemic glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in all groups; inhaled steroid use is not permissible) 15. Participants in close contact with anyone who has a severely weakened immune system and requires a protective environment. Exposure to such persons should be avoided for 7 days after receipt of LAIV. [If yes, may be ineligible for Groups A,B, C and F]. 16. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia). 17. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol 18. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year 19. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety. 20. Has taken an influenza antiviral medication within 48 hours prior to study vaccination [If yes, not eligible for LAIV Groups A, B, C and F]. 21. Receipt of blood or blood products within the past 6 months or planned used during the study 22. Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol. 23. Receipt of inactivated vaccine 14 days prior to study enrollment, or planned vaccinations prior to completion of last study visit 24. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned vaccination prior to completion of last study visit 25. Need for allergy immunization (that cannot be postponed) during the study period 26. History of Guillain-Barre syndrome 27. Pregnant woman 28. Breastfeeding [If yes, not eligible for LAIV Group F] 29. Use of investigational agents within 30 days prior to enrollment or planned use during the study 30. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or planned donation prior to completion of the last visit 31. Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Stroke A stroke caregiver is eligible to participate in the study if: 1. He / She is a Chinese adult aged 18 or above; 2. He / She has a family member has the first stroke (ischaemic or haemorrhagic stroke) at the age of 50 or above and has been discharged from the acute hospital for no more than 6 months; 3. He / She provides care or being with the stroke survivor for no less than two hours per day after discharge from the acute hospital; 4. He / She reports significant caregiver burden as measured by the 12-item Zarit Burden Interview (a total score ≥ 12). A stroke survivor is eligible to participate in the study if: 1. He / She is a Chinese adult aged 50 or above; 2. He / She has been discharged from the acute hospital for no more than 6 months; 3. His / Her family caregiver participates in this study; 4. He/ She is able to communicate with interventionists and interviewers; 5. He/ She is competent to give written informed consent. Stroke survivors whose caregivers in the intervention group will receive both the intervention and the questionnaire interviews. Stroke survivors whose caregiver in the control group will only need to take part in the questionnaire interview A stroke caregiver will be excluded from participation if: 1. His / Her family member has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke; 2. His / Her family member with stroke is residing in a residential care facility after discharge from the acute hospital; 3. He / She is diagnosed as having Alzheimer's disease or other dementias; 4. He / She is unable to understand Cantonese. A stroke survivor is not eligible to participate in the study if: 1. He / She is residing in a residential care facility after discharge from the acute hospital; 2. He/ She has a transient ischaemic attack without a major ischaemic or haemorrhagic stroke; 3. His / Her family caregiver refuses to participate in this study; 4. He/ She is not able to communicate with interventionists and interviewers; 5. He/ She is not competent to give written informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Cognitive Impairment Dementia Aging Participants in (NCT02422745) who meet the following are eligible to participate in this ancillary study: - 1. Men and women 65 years and older. 2. Willingness to participate. 3. Ability to answer questions by phone - 1. Participants who are co-enrolled in the WHI Memory Study. 2. Participants with insulin-dependent diabetes. 3. Participants who are unable to complete the baseline cognitive assessments | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Drug Hypersensitivity Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines patient refusal to take part in the study pregnancy breast feeding women contraindication to provocation test | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Sepsis Newborn Infection Infants admitted to the NICU at participating sites for > 2 days until discharge Babies requiring contact precautions due to other reasons (as glove based care would be occurring) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Dental Hygiene years old and older, having a good understanding of French language (read, write, speak, listen) With at least 20 teeth, including 4 first molars and 4 first or second premolars (4 interdental sites between premolars and molars) Patient attending an appointment in a centre participating to the trial Patient able to support treatment Patient affiliated to a health insurance scheme Patient giving his informed consent and accepting the modalities of the study Patient agreeing to attend up to 4 appointments dedicated to the study, during 8 weeks after the initial appointment (motivational interview) Patient in possession of an internet-enabled smartphone or tablet Patient has a personal e-mail address Patient agreeing to be registered within the system of text-based recalls for the duration of the study Patient having previously benefited from a periodontal therapy (less than 1 year ago) or currently enrolled in a periodontal therapy program Patient having previously benefited from an oral hygiene motivation session less than 1 year ago Patient has had a calculus removal procedure less than 1 month ago Patient bears orthodontic appliances (any kind, for 1 or both arches) Patient bears removable dental prosthesis (any kind, for 1 or both arches) Patient allergic to benzoic acid preservatives (or thought to be) Patient has a high risk of infective endocarditis Patient benefiting from antiaggregant or anticoagulation therapy Patient is haemophilic Patient is unable to answer questions | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 55.0-80.0, Sedentary Lifestyle Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire, and corrected vision of 20/40 Approval from a physician that monitored electrocardiography (ECG) response during a maximal aerobic fitness test that is part of the second study visit described below Exercising less than 60 minutes a week for the past calendar year Not between the ages of 55 and 80 years old Not fluent in English Score < 20 (out of 30) on the Montreal Cognitive Assessment (MoCA) Inability to comply with experimental instructions Qualify as "high risk" for acute cardiovascular event by the published standards of the American College of Sports Medicine Previous diagnosis of neurological, metabolic, or psychiatric condition, and no previous brain injury associated with loss of consciousness Inability to complete an MRI | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-2.0, Vaccination Mother-child (or caregiver-child) units with child <2 years of age OR Pregnant women Family does not have cell-phone OR cannot provide informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Hypertension Subject must provide signed written informed consent Men and women greater than or equal to 18 years of age at Screening Diagnosis of primary (essential) hypertension (HTN) for at least 3 months prior to Screening and have an office SBP Between 145 mmHg and 170 mmHg at Screening and are treatment-naïve; or Between 130 mmHg and 150 mmHg at Screening and are treated with less than or equal to 2 anti hypertensive medications. Anti-hypertensive medications must be stable for greater than or equal to 8 weeks prior to Screening SBP between 145 mmHg and 170 mmHg, inclusive, and DBP less than or equal to 105 mmHg at the Visit after 2-week Run In Period Body mass index between 25 kg/m2 and 45 kg/m2 with the ability to fit the ambulatory blood pressure monitoring (ABPM) cuff per the manufacturer Subject must have a successful ABPM measurement prior to receiving the study drug Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose Women of childbearing potential must have a negative serum pregnancy test result at Screening and a negative urine pregnancy test result at the Visit (Day 0) Known or suspected secondary HTN (eg, renal artery stenosis, pheochromocytoma, Cushing's disease) Office SBP greater than or equal to 171 mmHg and/or office diastolic blood pressure (DBP) greater than or equal to 105 mmHg at the Visit (Day 0) and confirmed by a second measurement (not on the same day), preferably within 1 day Known hypertensive retinopathy (Keith-Wagener Grade 3 or Grade 4) and/or hypertensive encephalopathy History of spontaneous or drug-induced angioedema Clinically significant valvular heart disease or severe aortic stenosis Subjects with symptomatic heart failure (New York Heart Association Class II to Class IV) History of acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to Screening Known history of malabsorption syndrome, or has undergone gastrointestinal surgery, including bariatric procedures, that induce chronic malabsorption, within 2 years of Screening Treatment with anti-obesity drugs or procedures 3 months prior to Screening (ie, surgery, aggressive diet regimen, etc.), leading to unstable body weight Female who is breast feeding, pregnant, or planning to become pregnant during the study period | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Cataract Age Related Macular Degeneration Participants in who 1) report a diagnosis of cataract or AMD, or extraction of cataract, and 2) provide written consent to obtain the medical records for the reported endpoint, are eligible for this ancillary study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Advanced Adult Hepatocellular Carcinoma Child-Pugh Class A Stage III Hepatocellular Carcinoma Stage IIIA Hepatocellular Carcinoma Stage IIIB Hepatocellular Carcinoma Stage IIIC Hepatocellular Carcinoma Stage IV Hepatocellular Carcinoma Stage IVA Hepatocellular Carcinoma Stage IVB Hepatocellular Carcinoma Participant must have histologically or radiographically confirmed hepatocellular cancer (HCC) that is advanced or metastatic and if archival tissue is available, have archival tissue submitted for PD-L1, PD-L2 testing Participants with measurable disease that has progressed are eligible if prior surgery or locoregional therapy occurred > 28 days prior to enrollment Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (Karnofsky >= 60%) Child-Pugh class-A liver function Absolute neutrophil count (ANC) >= 1,500/ mcL Hemoglobin >= 8.5 g/dL Platelets >= 75,000/ mcL Total bilirubin =< 2.0 mg/dL Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 5 X ULN Serum Creatinine <= 1.5 upper limit of normal (ULN)or Creatinine clearance > 50 mL/minute if serum creatinine is elevated above 1.5 X ULN One prior line of therapy that may a PDL1 blocker allowed, no prior sorafenib or PD1 blocker allowed Participants who have had radiotherapy or chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Any evidence of bleeding diathesis (patients on therapeutic warfarin or heparin will be excluded) Participants with a history of variceal bleed within 6 months prior to enrollment Known human immunodeficiency virus (HIV)-positive participants (even if on combination retrovirals, participant will be excluded Participants with chronic autoimmune disease Participants with known brain metastases should be excluded from this clinical trial 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 Has known history of, or any evidence of active, non-infectious pneumonitis Pregnant or nursing female participants | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Glycemic Response Good health Known history of AIDS, hepatitis, diabetes or a heart condition Use of drugs which would increase risk to the subject or affect the results in the opinion of the medical director Any condition which would increase risk to the subject or affect the results in the opinion of the medical director Individuals who cannot or will not comply with experimental procedures or do not follow safety guidelines | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-49.0, Influenza Subjects who meet all of the following may be included in the study: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status as determined by the Investigator 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome 5. Negative drug and alcohol screen at Screening and predose on Day 1 6. For women who have not been surgically sterilized or have laboratory confirmation of postmenopausal status, negative pregnancy test 7. Willingness to practice a highly effective method of contraception that may but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the NasoVAX/placebo dose 8. Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples 9. Provision of written informed consent Subjects who meet any of the following will be excluded from the study: 1. Pregnant, possibly pregnant, or lactating women 2. Household contacts of pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination 3. Persons who care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination 4. Body mass index > 35.0 kg/m2 5. Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening 6. Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with the any of the following events in the past year Daily symptoms Daily use of short acting beta 2 agonists Use of inhaled steroids or theophylline Use of pulse systemic steroids Emergency care or hospitalization related to asthma or other chronic lung disease Systemic steroids for asthma exacerbation 7. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range) 8. History of coronary artery disease, arrhythmia, or congestive heart failure 9. Clinically significant ECG abnormality as determined by the Investigator 10. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1 11. History of anaphylaxis or angioedema 12. Known allergy to any of the ingredients in the vaccine formulation 13. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration 14. Previous nasal surgery or nasal cauterization 15. Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1 16. Any symptoms within 24 hours before Day 1 of upper respiratory illness of allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP 17. Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur 18. Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period 19. Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1) 20. Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1 21. Receipt of any investigational product (IP) within 30 days before Day 1 22. Receipt of any vaccine within 30 days before Day 1 23. Receipt of intranasal vaccine within 90 days before Day 1 24. Receipt of any influenza vaccine within 6 months before Day 1 25. Any change in medication for a chronic medical condition within 30 days before Day 1 26. Past regular use or current use of intranasal illicit drugs 27. Smoking of any type (eg, cigarettes, electronic cigarettes, marijuana) or use of any tobacco product within 30 days before Day 1 28. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.5-70.0, Food Allergy Patients ages 6 months through 70 years who have previously undergone a food immunotherapy protocol only at our center None. However, if a participant becomes pregnant, their clinic visit may be postponed until after delivery and/or lactation period. These subject can postpone visits for one year and choose to skip visits during pregnancy and another year after (if breastfeeding) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-0.003, Newborn Vaccine Immunogenicity <24 hours of age >37 weeks gestational age HIV unexposed Healthy (no malformations, normal temperature range and vital signs for age) Premature (<37 weeks gestational age) Hepatitis B antigen-positive mother HIV-positive or HIV-exposed Febrile, unstable vital signs | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Lead Poisoning healthy subjects who consent to a capillary blood collection Patients are not currently taking chelating agents, e.g., penicillamine, succimer | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-90.0, Stroke diagnosis of stroke patient at the Brookdale Center for Healthy Aging & Rehabilitation not greater than maximum assistance to walk 10 feet walking re-training included in the therapy plan of care primary diagnosis other than stroke allergy or reaction to the wrist bands of the activity monitors | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Pelvic Gynecological Cancer ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary) at any stage of the disease patient coming for anesthesia consultation before hysterectomy informed signed consent patient affiliated to or beneficiary of social security patient <18yrs patient with a pelvic gynecological cancer that does not require hysterectomy patient with psychiatric history or a depressive syndrome deaf patient (deafness makes the hypnosis session impossible) patient under legal protection | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Influenza Volunteer is willing and has capacity to provide written informed consent for participation in the trial (in the Investigator's opinion) Male or female adults, aged 65 years and above Able and willing (in the Investigator's opinion) to comply with all study requirements Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner Eligible to receive seasonal influenza vaccine Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine (e.g. egg allergy) Ongoing terminal illness with a life expectancy estimated to be approximately <6 months Continuous use of oral anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban) Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study Participation in another clinical trial of an investigational medicinal product in the 30 days preceding enrolment, or planned use during the study period Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data Receipt of annual seasonal influenza vaccine prior to enrolment (for the same influenza season volunteers are recruited in) Not willing to comply with study procedures | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-999.0, Rotavirus Infections Environmental Enteric Dysfunction Enteric Infections Mother residing in an intervention or control compound of a previous sanitation trial (NCT02362932) for at least 6 months prior to recruitment and not intending to switch study compound over the next 9 months 2. Mother being pregnant and having gestational age between 3 and 9 months or being puerperal (up to 40 days postpartum) 3. Mother planning to use the prenatal care, delivery and vaccination services provided by the Ministry of Health of Mozambique 4. Mother able to understand and complete the informed consent process and allow your newborn to participate in the study 5. Mother at least 16 years of age 6. Infant eligible to receive rotavirus vaccination Infant whose medical team considers that they cannot be part of the study 2. Infant with complications associated with gestation, childbirth or postpartum, including congenital malformations 3. Infant with any medical, psychiatric or social condition, occupational reason, or other responsibility on the part of the pregnant woman, which, in the opinion of the investigator, is a contraindication to protocol compliance or impedes the participant's ability to give informed consent 4. Infant who has already received the rotavirus vaccine | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Viral Vaccines adults capable of providing consent have a diagnosis of locally advanced or metastatic melanoma are allergic to influenza vaccination have received influenza vaccination within the past 6 months require prednisone, methotrexate, or other immunosuppressing medications have HIV infection have a history of solid organ or bone marrow transplant require combination immunotherapy are on other studies requiring blood draws that might exceed 450 mL total during the period of the influenza vaccine study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 19.0-64.0, Avian Influenza Influenza Influenza Immunisation Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 19 -64 years of age, inclusive. 4. Are in good health As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, Emergency Room (ER), or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription 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 deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject ), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.0°F. 6. Pulse is 47 to 100 beats per minute (bpm), inclusive. 7. Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects <65 years of age), 85 to 160 mmHg, inclusive (subjects = / > 65 years of age). 8. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 9. ESR is less than 30 mm per hour. 10. Women of childbearing potential must use an acceptable contraception method from 30 days before first study vaccination until 60 days after last study vaccination Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal. - Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill"). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. 4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. 5. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted. 6. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. 7. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine. 8. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines. 9. Have a personal or family history of narcolepsy. 10. Have a history of Guillian-Barre Syndrome (GBS). 11. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. 12. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs). 13. Have a history of alcohol or drug abuse within 5 years prior to study vaccination. 14. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 15. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination. 16. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. 17. Have taken high-dose inhaled corticosteroids within 30 days prior to each study vaccination High-dose defined per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-refere nce-html#estimated-comparative-daily-doses 18. Received a licensed live vaccine within 30 days prior to the first study vaccination, or plan to receive a licensed live vaccine within 30 days before or after each study vaccination. 19. Received or plan to receive a licensed, inactivated, vaccine (excluding all flu vaccines) within 14 days before or after each study vaccination. 20. Received or plan to receive the 2017-2018 inactivated seasonal flu vaccine prior to or during the clinical trial and for the remainder of the 2017-2018 season. 21. Received Ig or other blood products (with exception of Rho D Ig) within 90 days prior to each study vaccination. 22. Received an experimental agent within 30 days prior to the first study vaccination, or expect to receive an experimental agent during the 13-month trial-reporting period Including vaccine, drug, biologic, device, blood product, or medication. - Other than from participation in this trial. 23. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the 13-month trial-reporting period Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 24. Received or plan to receive an influenza A/H7 vaccine or have a history of influenza A/H7 subtype infection | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Cystic Fibrosis have CF and are willing to complete a questionnaire during a routine clinic visit - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-84.0, Mild Cognitive Impairment Age 50 to <85 years. 2. Evidence of amyloid pathology on Florbetapir PET at screening. 3. Diagnosis of MCI due to AD based on NIA-AA criteria. (APPENDIX A) 4. MRI brain (with past 24 months) which shows evidence of mild hippocampal atrophy and/or bilateral parietal atrophy. 5. CDR score of 0.5 6. Mini-Mental State Examination (MMSE) score of 24-30, inclusive. 7. Rosen Modified Hachinski Ischemic score ≤4. 8. Receiving stable doses of medication(s) for the treatment of non-excluded medical condition(s) for at least 30 days prior to screening. Cholinesterase inhibitors and memantine are allowed if doses have stable been least 30 days prior to screening. 9. Agree to refrain from participating in any treatment or clinical trial targeting amyloid for the duration of the study. 10. Agree to refrain from taking any herbal supplement considered to enhance cognition unless approved by the investigator for the duration of the study. 11. Ability to attend all clinical visits and have an informant capable of accompanying the subject on specific clinic visits. 12. The subject's collaborative informant (support person) must be someone who has known the subject for at least 4 years and has had approximately 2 or more separate communications with the study participant per month (at least one of these communications in person). 13. Fluency in English and evidence of adequate premorbid intellectual functioning. 14. Adequate manual dexterity, visual, and auditory abilities to perform all aspects of the cognitive and functional assessments. 15. Venous access suitable for repeated infusions and phlebotomy. 16. In the opinion of the investigator, the subject and informant will be compliant and have a high probability of completing the study, including all scheduled evaluations and required tests Has significant neurological disease other than MCI that in the opinion of the investigator may affect cognition. 2. History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque. 3. History of seizures, excluding febrile seizures in childhood. 4. History of screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to multiple microhemorrhages (2 or more), history or evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space occupying lesions of significance as determined by the PI (e.g., arachnoid cysts or brain tumors such as meningioma). 5. Brain MRI shows moderate or severe cortical or hippocampal atrophy. 6. Sensitivity to Florbetapir. 7. Other present/planned ionized radiation that, in combination with planned exposure to PET ligands for this study, would result in cumulative exposure that would exceed recommended limits. 8. Ophthalmologic condition that would interfere with retinal amyloid imaging. 9. Current presence of a clinically significant major psychiatric disorder (e.g., Major Depressive Disorder) according to the of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) or symptom (e.g., hallucinations) that in the opinion of the investigator could affect the subject's ability to complete the study. 10. Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study including but not limited to renal failure or myocardial infarction. 11. History of cancer within the last 5 years, with the exception of nonmetastatic basal cell carcinoma, and squamous cell carcinoma of the skin. 12. Uncontrolled hypertension (diastolic BP> 100 mmHg or systolic BP> 160 mmHg, sitting). 13. History or evidence of any clinically significant autoimmune disease or disorder of the immune system (e.g., Crohn's Disease, Rheumatoid Arthritis) 14. Clinically significant infection within the last 30 days (e.g., chronic persistent or acute infection (eg, upper respiratory infection [URI], urinary tract infection [UTI]). 15. Female subjects of childbearing potential. 16. Other clinically significant abnormality on physical, neurological, laboratory, vital signs or ECG examination (e.g., atrial fibrillation) that could compromise the study or be detrimental to the subject. 17. Weight greater than 120 kg (264 lbs). 18. Excessive smoking defined as more than 20 cigarettes per day. 19. History of alcohol or drug dependence or abuse as defined by DSM-IV within the last 2 years. 20. Severe liver or kidney disease verified by the PI review of ALT, AST and creatinine. 21. Known coagulopathy, thrombosis, or low platelet count. 22. Hemoglobin less than 11 g/dL. 23. Known deficiency to IgA. 24. Positive serology for Hepatitis B or C, or HIV. 25. History of anti-amyloid treatment, immunotherapy, or other experimental treatment for MCI or Alzheimer disease. 26. Concurrent use of anticholinergic drugs including diphenhydramine. 27. Current use of anticoagulant medications (except the use of aspirin 325 mg/day or less, plavix, aggrenox, and persantine but not for stroke). 28. Concurrent use of opioid pain relievers and related synthetic derivatives | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Solid Organ Transplant Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication Age ≥ 18 Outpatient status Greater than 30 days post-transplant Has already received influenza vaccination for 2017-2018 season Egg allergy or allergy to previous influenza vaccine Febrile illness in the past one week Active Cytomegalovirus viremia Use of Rituximab in the past one year Ongoing or recent (in past 30 days) therapy for acute rejection Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent Previous life-threatening reaction to influenza vaccine (i.e., Guillain Barre Syndrome) Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next four weeks | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 9.0-99.0, Influenza Influenza Immunisation Aged equal to or greater than 9 years of age and weigh at least 50 pounds 2. The subject must be in good health, as determined by: medical history; and targeted physical examination, when necessary, based on medical history. Stable medical or psychiatric condition is defined as: no recent increase 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 3. The subject is able to understand and comply with the planned study procedures, including being available for all study visits 4. The subject/parent has provided informed consent/assent prior to any study procedures 5. Subjects who have not received seasonal flu vaccine for the current year Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine 2. Subject report of known latex allergy 3. Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines 4. Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine 5. The subject is a female of childbearing potential who is currently pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 90 days following receipt of vaccine. Pregnancy will be determined by subject interview. Pregnancy testing is not done in this study since there is no increased risk in pregnancy 6. The subject is immunosuppressed 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 7. The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years 8. Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-refere nce-html#estimated-comparative-daily-doses 9. The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study 10. The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days after vaccination 11. The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions any acute or chronic medical disease or conditions defined as persisting for 3 months (defined as 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study 12. Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9 degrees Fahrenheit (37.7 degrees Celsius) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved > 3 days prior to enrollment 13. The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period 14. The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol 15. The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment 16. The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection 17. Subject weighs less than 50 lbs 18. Subject expects to have a medical procedure during the upcoming 8 weeks that estimates blood loss to exceed 400 cc for adults or for children would exceed 3 ml/kg | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Procedural Bleeding Delayed Bleeding Post-Polypectomy Syndrome Post Procedural Complication Sex and age: men and women > 18 years old 2. Subjects referred for EMR of polyps of size ≥11 mm 3. ASA score 1, 2 or 3. 4. Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care). 5. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent Age: Subjects is under 18 years old 2. Consent: Vulnerable subjects including those who are unable to consent 3. Pregnancy: Pregnant or breastfeeding women 4. ASA score <3 5. Physical findings: Abnormal physical findings that may interfere with the study objectives 6. Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days 7. Excluded lesions Lesions less than 11 mm in largest dimension Lesions involving the muscularis propria (T2 lesions) Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma Proven malignant disease locally advanced or with metastasis Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease Endoscopic appearance of invasive malignancy 8. Previous partial resection or attempted resection of the lesion 9. Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs 10. Severe liver disease. 11. Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon, 12. Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease 13. Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR>1.5). 14. Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study. 15. Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-100.0, Primary Family Caregivers of ICU Patients Ages 18 years and over Family members (spouse, parents, or children) of patients who stay in the ICU for more than 3 days Provision of the majority of unpaid physical, emotional, and/or instrumental care to the patients Voluntarily agreement with participation in the study A history of cognitive impairment (e.g., dementia), psychiatric disorders or neurological disorders Indication of discernible hearing deficits Difficulties in verbal communication If the caregiver's relationship to a patient is close friend or relatives (not immediate family of patients) Refusal to participate in the study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-50.0, Obesity Aged 18 to 50 years BMI ≥ 27 kg/m2 Weight ≤ 350 lb Medical clearance from a primary care provider Willingness to follow a VLC weight-loss diet Willingness to reside in a research unit for 3 months and eat/drink only provided study foods and beverages No major food allergies or aversions Willingness to obtain seasonal flu shot or provide documentation of flu shot for current flu season (winter/spring cohort only) Willingness to discuss work options (e.g., remote work) with employer, and make appropriate arrangements prior to the Residential phase Change in body weight ≥ 10% during prior 6 months Specialized diets (e.g., for medical or religious reasons) Chronic use of any medication or dietary supplement that could affect study outcomes (e.g., insulin, metformin, thyroxine) Current smoking (1 cigarette in the last week) Greater than moderate alcohol consumption (> 14 drinks/wk) or history of binge drinking (≥5 drinks in 1 day within past 6 months) Physician diagnosis of a major medical illness or eating disorder History of kidney stones Laboratory tests: ALT>2x upper limit; abnormal HgA1c; abnormal TSH; abnormal creatinine; abnormal uric acid (using the male upper limit for both sexes) Failed criminal offender background check or sex offender background check Use of recreational drugs | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Term Labour A woman will be considered for in the study if she fulfills all of the following She has a term or near term (≥36 completed weeks) singleton gestation in a cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of spontaneous labor, or has been admitted for induction of labor She has given her informed consent to participate as a subject She has none of the Known major fetal malformation or chromosome abnormality Multiple gestation A condition for which cesarean will likely be carried out shortly Subject plans not to have electronic fetal monitoring Involvement in another clinical trial currently or previously in this pregnancy that, in the investigator's opinion, would affect the conduct of this study Medical or obstetric problem that would preclude the use of abdominal electrodes (e.g., skin eruptions, history of sensitivity to adhesives) Parturient is under age 18 Medical or obstetric problem that in investigator's opinion would make the patient incapable of taking part in the study Inability to understand the consent information due to medical illness or diminished intellectual capacity, or insurmountable language barrier Potential for coercion, e.g. Medical Center employees, prisoners | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-44.0, Plasma Volume Micronutrients Menstrual Cycle Female to 44 years of age General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital) BMI 18.5-24.9 kg/m2 Regular menstrual cycle (26-35 days) Non-smoker Non-pregnant If pregnant before, ≥12 months since last pregnancy Known allergy to shellfish or iodine Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) <90 or ≥130 mmHg and/or diastolic blood pressure (DBP) <60 or ≥80 mmHg) Currently has low or high blood pressure (SBP <90 or ≥130 mmHg and/or DBP <60 or ≥80 mmHg), self-reported Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia) Taking regular medication(s) (physician's prescribed medications for a health condition) Currently trying to conceive Currently breastfeeding Currently using hormonal birth control or used within last 3 months Used depot medroxyprogesterone acetate (DMPA) in the past 12 months Diagnosis of polycystic ovary syndrome | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Human Papillomavirus Infection Pediatric or family medicine clinics or practices in New York, Wisconsin, or Arizona with at least 200 active records for patients, ages 11-17, in their states' immunization information systems Less than 200 active records for patients between 11-17 | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Acute Respiratory Infection Influenza-like Illness Gastrointestinal Infection At least 18 years or older No known allergies to alcohol or surface disinfecting wipes Works at least 30% of office hours at the study host site Consent to receiving emails from Kent State University Under 18 years of age Known allergies to alcohol or surface disinfecting wipes Works less than 30% of office hours at the study host site Does not consent to receiving emails from Kent State University | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-59.0, Healthy Male or female between the ages of 18 and 59 years old Volunteers who have not received a vaccination within 30 days of the YFV and do not anticipate to receive a vaccination within 30 days Volunteers who are seeking the YFV for either travel reasons or occupational risk Volunteers willing to undergo one screening visit, one visit to receive the YFV, and four post-vaccination visits Volunteers without medical conditions who are willing to give blood once for the development of the inDrop technique Male or females under 18 or over 59 years of age Volunteers who received other vaccination less than 30 days prior to receiving the YFV Volunteers with acute or febrile disease Volunteers unable to return for the post vaccination follow-up visits Volunteers with an allergy to eggs, chicken proteins, gelatin, or other components of the Yellow Fever vaccine Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study Is pregnant or lactating Volunteers with a history of yellow fever vaccination and/or infection Volunteers with a history of viral hepatitis and/or non-viral liver disease In the opinion of the investigators, the volunteer is unlikely to comply with the study protocol | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-65.0, Vaccination Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.) Read, signed and dated Informed Consent Form Pregnant or breast-feeding women Uncontrolled serious infection i.e., not responding to antimicrobial therapy History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor History of allergies or reactions to eggs, egg products, or gentamycin Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination Use of any investigational or non-registered drug or vaccine other than within 30 days preceding the first vaccine dose | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Female Able to give consent Gestational age > 24 weeks Postpartum Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours Primary obstetrician amenable to proceeding with either method of management during the study period Age < 18 years old IBT removed within 2 hours of placement Chorioamnionitis Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Spondyloarthritis Psoriatic Arthritis Patients with RA: Registered in with a diagnosis of M05.9, M06.0 or M06.9 Patients with SpA: Registered in with a diagnosis of M45.9, M46.1, M46.8+M02.9, M46.8+M07.4, M46.8+M07.5 or M46.9 Patients with PsA: Registered in with a diagnosis of M07.3 or M46.8+M07.2 First bDMARD treatment course Start of treatment with first bDMARD in the period January 1, 2006 to December 31, 2016 Age at start of treatment with first bDMARD ≥ 18 years Not followed in since start of first bDMARD | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, The Well Being of Parents of Children With Food Allergies Being a parent of at least one child (under the age of 18) who has a food allergy Adequate understanding of written English Having consulted on the design of the self-help website | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-70.0, Menopause Exercise Blood Pressure, High amenorrhea for at least 12 months; body mass index ≤30 kg/m2; ability to engage in treadmill and resistance exercises; hypertension nom-medicated with beta-blockers history of diabetes, cancer or cardiovascular disease (except for hypertension in Hypertensive group); doing hormone therapy or soy derived supplementation; smokers | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Hereditary Hemorrhagic Telangiectasia Dental Diseases patients having telangiectasia and nosebleeds or nosebleeds in the family | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Neoplasms Ability to understand and the willingness to sign a written informed consent. 2. 18-75 year old patients with newly-diagnosed cancer scheduled to undergo anthracycline-based chemotherapy (minimum of 200 mg/m2 of doxorubicin or equivalent) at UCSD Medical Center. 3. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. • A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) 4. Women of child-bearing potential must have a negative pregnancy test during the screening period Prior chemotherapy with anthracycline; 2. Persistent tachycardia (heart rate>90); 3. LVEF<53% or history of cardiomyopathy or decompensated heart failure; 4. Baseline GLS below lower limit of normal (normal range varies depending on age and gender (23)) or inability to obtain meaningful strain data due to poor quality of Echocardiographic images; 5. Known unrevascularized coronary artery disease, myocardial infarction within 30 days of enrollment; 6. Moderate or severe valvular heart disease; 7. Prior allergy or intolerance to iodinated contrast; 8. Renal failure (GFR<30, creatinine >1.5); 9. Cancer involvement of the heart | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Immunodeficiency included participants be more than 60 years of age. Volunteers underwent a physical examination and health assessment by a physician to ensure the absence of which were regular consumption of greater than one unit of milk and/or milk products (milk, yogurt, fresh cheese, etc.) a day at the time of enrollment, known milk allergy, food faddism, other non-traditional diet, prolonged consumption of dairy supplements (greater than one daily during the previous four weeks), use of tobacco products in the previous 10 years, underlying neoplasia or immunological disease, including hypergammaglobunemia, renal disease or failure, use of steroids or immunosuppressive drugs in the previous eight weeks, reduced physical activity (New York Heart Association classes III-IV). Having received a DTaP vaccine within the last five years was an for the study, but patient records were incomplete for many volunteers on this aspect. Therefore, volunteers with an initial Tetanus antibody level above 3 IU/mL were excluded from the study results as the volunteer was assumed to have had the DTaP vaccine within the last 5 years | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Non-small Cell Lung Cancer Histologically confirmed Stage IV or recurrent Non-small cell lung cancer squamous or non-squamous histology (Stage IV as diagnosed using the 7th edition of Lung Cancer Stage Classification), with no prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease. Prior adjuvant chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy is permitted as long as the last administration of the prior regimen occurred at least 6 months prior to study enrollment. Patients with EGFR, ALK, or ROS1 alterations must have received one prior TKI A core needle biopsy or surgical specimen must be available for submission At least one site of disease that is measurable by Response Evaluation in Solid Tumors (RECIST) Version 1.1 that has not been previously irradiated; if the patient has had previous radiation to the marker lesion(s), there must be evidence of progression since the radiation Age ≥ 18 years with ability and willingness to provide informed consent ECOG performance status 0 or 1 Negative pregnancy test done ≤72 hours (or per institutional policy) prior to treatment, for women of childbearing potential only. Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test or must have evidence of non-child-bearing potential by fulfilling one of the following at screening: 1. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments. 2. Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution 3. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation Men and women of childbearing potential must agree to use medically accepted barrier methods of contraception (e.g. male or female condom) at the time of pregnancy test (women of childbearing potential only), during the course of the study and for 90 days after the last dose of study drug, even if oral contraceptives are also used. All subjects of reproductive potential must agree to use both a barrier method and a second method of birth control during the course of study and for 90 days after the last dose of study drug A concurrent diagnosis of a separate malignancy is allowed if clinically stable and does not require tumor-directed therapy Provision of written informed consent including HIPAA according to institutional guidelines prior to any study-specific procedures Patients must agree to research blood sampling to participate in study Subjects with known EGFR mutations which are sensitive to available targeted inhibitor therapy and must have received treatment with at least one prior tyrosine kinase inhibitor (TKI) Subjects with known ALK or ROS1 translocations which are sensitive to available targeted inhibitor therapy must have received treatment with at least one prior TKI Radiation therapy within 14 days prior to day 1 of study drug Experimental agents within 28 days prior to day 1 of study drug Intolerance of nivolumab or other PD-1/PD-L1 axis drug(s), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways, including prior therapy with anti-tumor vaccines or other immune-stimulatory anti-tumor agents Known auto-immune conditions requiring systemic immune suppression therapy other than prednisone < 10 mg daily (or equivalent) History of interstitial pneumonitis from any cause Concurrent severe and/or uncontrolled medical conditions which may compromise participation in the study, including impaired heart function or clinically significant heart disease Pregnant or breast feeding Not willing to use an effective method of birth control medically accepted barrier methods of contraception (e.g. male or female condom) at the time of pregnancy test (women of childbearing potential only), during the course of the study and for 90 days after the last dose of study drug | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 21.0-999.0, Hypertension Patients already on free triple anti-HTN therapy whether controlled or not Or patients on double anti-HTN therapy who are uncontrolled* Or patients on monotherapy and who have a BP > 160/100 mm Hg BP is defined as if > 135/85 at home or > 140/90 in clinic on at least 2 occasions Contra-indication for the use of ARB or ACEI, CCB or hydrochlorothiazide History of angina pectoris or myocardial infarction < 3 months old Permanent atrial fibrillation Ejection fraction < 40% Patients with hypertension but who are not on any medication Patients with hypertension and who are treated with > 3 drugs | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-20.0, Influenza, Human Immune Response aged 4-20 years has prior vaccination history available (which can be determined based either on medical record review or through state registry review plans to receive the current seasonal influenza vaccination at one of the recruiting sites unable or unwilling to completed required study activities, including informed consent, randomization to vaccine, and bloodwork has already received influenza vaccine for the current season has a known immunocompromising condition or is on an immunosuppressing medication (e.g., high dose steroids >10 days) is known to be pregnant has a history of severe allergy to eggs or to influenza vaccine or any of its components | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Influenza Virus Infection For patients with flu-free flu, cough for at least one week. 1. In line with the flu etiological diagnostic According to the guidelines set by the National Health and Health Committee, the diagnosis is based on etiological screening methods or confirmed methods; ages 18 to 70 years. 2. There are no influenza complications such as acute lower respiratory tract infection, tonsillitis, sinusitis, otitis media, myocarditis, etc. 3. It is usually healthy and there are no chronic underlying diseases such as hypertension and diabetes. 4. Treating with cough as the main symptom, the cough lasts for at least one week and the chest radiograph is normal. 5. Signed informed consent Suspected flu patients who have not received the flu etiology test; 2. There is a clear comorbid disease (combined with other sites of acute bacterial or viral infections); 3. There is a clear cough caused by other reasons; 4. With severe liver and kidney dysfunction; 5. Pregnant women | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Human Papilloma Virus Vaccines Attitude to Health years of age or older Lives in one of 26 US states with lower rates of HPV vaccination (New Jersey, Virginia, West Virginia, Alabama, Florida, Kentucky, Mississippi, North Carolina, South Carolina, Tennessee, Indiana, Minnesota, Ohio, Arkansas, Louisiana, New Mexico, Oklahoma, Kansas, Missouri, Montana, South Dakota, Utah, Wyoming, Idaho, Texas, Iowa) Mother or female legal guardian of at least one child aged 11-14 years Able to read and understand English Target child must not have received any doses of HPV vaccine The mother/respondent must indicate that she is not sure that she will vaccinate the target child in the next year Under 18 years of age Not a mother or female legal guardian of at least one child ages 11-14 years Not living in the United States or in one of the above designated states within the U.S Not able to understand or read English Target child has already received at least 1 dose of HPV vaccine The mother/respondent indicates (before the intervention) that she definitely intends to vaccinate the target child with HPV vaccine in the next year | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 6.0-12.0, Innate Immunity Periodontal Health Systemically healthy children Any medications known to affect defense system and periodontium The presence of orthodontic / intraoral appliance | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-35.0, Cryotherapy Effect male between the ages of 18-35 recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session) chronic health problems fever or current illness at the time of testing history of cardiovascular, metabolic, or respiratory disease current musculoskeletal injury that limits physical activity history of exertional heat illness in the past three years | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 42.0-71.0, Influenza Capable of informed consent and provision of written informed consent before any study procedures. 2. Capable of attending all study visits according to the study schedule. 3. Males or females born between 1968-1977 or 1948-1957. 4. Are in good health, as determined by medical history and targeted physical exam related to this history. 5. Oral temperature is less than 38C. 6. Resting pulse rate is between 50 and 100 beats per minute. 7. Female subjects of childbearing age must have a negative urine pregnancy test within 24 hours before study vaccination. 8. Have received the influenza vaccine at least 3 of the past 5 years (between September 2013-June 2018) or have received the influenza vaccine in 2 or less of the past 5 years (between September 2013-June 2018) Have an acute illness within 72 hours before vaccination. 2. Have any condition that, in the opinion of the principal investigator, would place the subject at an unacceptable risk of harm or confound the interpretation of the study results. 3. Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination. 4. Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination. 5. Have known HIV, hepatitis B, or hepatitis C infection. 6. Have a known history of autoimmune disease. 7. Have taken oral or parenteral corticosteroids of any dose within 30 days before study vaccination. 8. Have taken high-dose inhaled corticosteroids within 30 days before study vaccination. 9. Have received, or plan to receive, any licensed live vaccine within 30 days, or any licensed inactivated vaccine within 14 days, prior to, or after, study vaccination. 10. Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation. 11. Have received immunoglobulin or other blood products, with the exception of Rho D immunoglobulin, within 90 days prior to study vaccination. 12. Have donated blood or blood products within 30 days before study vaccination, or within 60 days after study vaccination, or plan to donate blood within 30 days of the last blood draw. 13. Have known hypersensitivity or allergy to eggs, egg protein, chicken protein, or other compounds of the study vaccine. 14. Have a history of severe reactions following vaccination with influenza virus vaccines | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 6.0-16.0, Vaccination Children age 6 to 16 years 2. Patients arriving to the immunization clinic for immunization. 3. Parents will sign a consent form and children will sign an assent form Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) 2. Facial features or injury prohibiting wearing the VR goggles 3. VR system may interfere with immunization | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza, Vaccination Enrollment in Sendero IdealCare health plan as of August 1, 2018 Age 18 years or older A coverage termination date listed prior to December 31, 2018 Sendero member records lack both a phone number and email address | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Influenza A Subtype H5N1 Infection Participated in Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine with and without AS03 Adjuvant study Capable of informed consent and provision of written informed consent before any study procedures Capable of attending all study visits according to the study schedule Are in good health, as determined by medical history and targeted physical exam related to this history Female subjects of childbearing age must have a negative urine pregnancy test before study vaccination, and must use at least one form of contraception to avoid pregnancy for 28 days before and 28 days after Fluarix Quadrivalent administration Have an acute illness, including any fever (> 100.4 F [> 38 degrees C], regardless of the route) within 72 hours before vaccination Have any acute or chronic medical condition that, in the opinion of the principal investigator, would make vaccination unsafe or interfere with the evaluation of immune response to study vaccination Alcohol or drug abuse and psychiatric conditions that, in the opinion of the investigator, would preclude compliance with the trial or interpretation of safety or endpoint data Have a suppressed immune system as a result of illness, immunosuppressive medication, chemotherapy, or radiation therapy within 3 years prior to study vaccination Are pregnant or breastfeeding or plan to within one month of vaccination Have taken oral or parenteral corticosteroids of any dose within 28 days before study vaccination Have a known history of autoimmune disease Have a history of Guillain-Barre Syndrome Have a history of bleeding disorders Have known hypersensitivity or allergy to any component of the vaccine, including egg and latex allergies, or history of anaphylaxis with influenza vaccine or vaccine component | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Women With Breast Cancer the X-ray images of the breast were complete the results of pathological diagnosis or more than 2 years of mammography follow-up were available subject signs informed consent(this item was only for prospective study cases) there exists pathological diagnosis of breast lesions when receiving mammography there lacks pathological diagnosis or 2 years of mammography follow-up subject withdraws(this item was only for prospective study cases) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Influenza-like Illness Eligible for care in Department of Defense medical facilities (Defense Enrollment Reporting System eligible) 2. ≥18 years of age. 3. At a participating Military Treatment Facility site for the purpose of receiving a seasonal (2018-2019, 2019-2020,2020-2021) influenza vaccination. 4. Able to speak English and able to provide informed consent 5. Able to receive and respond to texts and/or emails, or a military recruit Adults intending to receive or who have received the current seasons FluMist Vaccine (LAIV) 2. Adults who have already received a flu vaccine within the current season 3. Individual who cannot receive a flu vaccine or standard dosing due to another medical condition 4. Allergic to gentamicin, polymyxin and/or neomycin 5. Individuals who fail to meet the | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-45.0, Influenza Influenza, Human Vaccine Reaction Influenza A Influenza Type B Influenza A H1N1 Influenza A H3N2 Provide written informed consent prior to initiation of any study procedures Are able to understand and comply with planned study procedures and be available for all study visits Are males or non-pregnant females, 18-45 years of age, inclusive Are in overall good health. (As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses that could affect the assessment of the immunogenicity of influenza vaccine.) Women of childbearing potential (not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful metal coil placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal.) must use an acceptable contraception method (includes, but is not limited to, non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill")) from 30 days before vaccination until 30 days after vaccination Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to vaccination Have an acute illness (an acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol) as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to vaccination Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to vaccination Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection Have known hypersensitivity or allergy to components of cell-cultured influenza vaccine Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines Have a history of Guillain-Barre Syndrome Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to vaccination | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, Diabetes Mellitus, Type 2 Informed consent obtained before any study-related activities. Study-related activities are any procedures related to recording of data according to the protocol The decision to initiate treatment with commercially available insulin Ryzodeg® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to the patient in this study Male or female, age more than or equal to 20 years (the legal age of adulthood) at the time of signing informed consent Diagnosed with type 2 diabetes (T2D) for at least 26 weeks prior to signing informed consent Available and documented glycosylated haemoglobin (HbA1c) value less than or equal to 12 weeks prior to initiation of Ryzodeg® treatment For at least 26 weeks prior to initiation of Ryzodeg® treatment, one of the following must apply: A) Treated with insulin glargine (IGlar) (any formulation, including biosimilar IGlar). B) Treated with IGlar (any formulation, including biosimilar IGlar) and IGlar U300 for at least 12 weeks prior to initiation of Ryzodeg® Previous participation in this study. Participation is defined as signed informed consent Pregnancy Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Hypersensitivity to Ryzodeg® or to any of the excipients Previously treated with Ryzodeg® | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Postoperative Pain Pregnant women at least 18 years of age 2. Gestational age > or = to 30 weeks 3. Singleton gestation 4. Women undergoing a non-emergent cesarean delivery 5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean 6. Ability to undergo the informed consent process in English Vertical skin incision 2. General anesthesia for cesarean 3. History of major depression or postpartum depression requiring medication 4. Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not opioids given for labor anesthesia. 5. Magnesium sulfate treatment postpartum 6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-16.0, Diagnoses Disease childrens admitted inside Assiut university hospital with ME and fullfilling it's symptoms and signs -Childrens with symptoms and signs that are not consistenet with ME | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-80.0, Latent Tuberculosis Age 18 years + 1 day (defined as date of birth plus one day). This age cutoff has been selected as tstin3d.com has only been validated for this age group. Subjects must have all of the following Untreated Latent Tuberculosis Infection (LTBI), defined as positive Tuberculin skin test/QuantiFERON TB Gold test or T-spot assay done within 1 month prior to enrollment Absence of active TB disease as determined by history, physical examination, chest X-ray, (sputum smear and/or culture done as needed by the assessing physician for Mtb) Greater than 10% cumulative risk of developing active TB disease (determined by TSTin3D.com) A subject will be excluded if any of the following are met Presence of active TB disease BMI <16 Cardiovascular instability (Blood pressure: Systolic >180 or <90 mm/Hg or Diastolic >100 or < 50mm/Hg; pulse <40 or >110) Chest X-Ray report within last 3 months not available HIV positive and currently on treatment with a regimen that has severe drug interactions with 3HP Presumed infected with INH or Rifapentine (RIF)-resistant M. tuberculosis Women who are pregnant, nursing or expect to become pregnant for the duration of the study Temperature ≥38.5°C or other clinical evidence of an acute infection at screening History of treatment for >14 consecutive days with a rifamycin or >30 consecutive days with isoniazid during the previous 2 years | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-69.0, Hypertension Hypertension Complicated With Type 2 Diabetes Walking Chinese Square Dancing 40-69 years of age 2. Meet any one of the two conditions: 2.1 Hypertension: diagnosed with hypertension, systolic blood pressure is 130-159 mmHg, take no antihypertensive drug or no more than 2 kinds of antihypertensive drugs 2.2 Hypertension complicated with diabetes: diagnosed with hypertension and type 2 diabetes, systolic blood pressure is 130-159 mmHg and the fasting blood glucose in the past 2 weeks was 5.6-16.7 mmol/L (13.8-16.7 mmol/L was negative for urinary ketone) , take no more than 4 kinds of antihypertensive and hypoglycemic drugs 3. Maintain the current state of medication for the next 3 months 4. Lived in the current community in the past six months 5. Have no intention of moving out for the next three months 6. Have no regular exercise habit (moderate intensity activity less than 3 times a week, less than 30 minutes each time or 30 minutes cumulative), at least exercise 3 days a week 7. Sign informed consent Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living) 2. Physical disability that prevents patients from walking or Chinese square dancing 3. Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education) 4. Pregnant or planning to become pregnant 5. BMI(body mass index)≥35 kg/m2 6. Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes" 7. Cardio-cerebrovascular events have occurred in the past 6 months(heart disease diagnosed by doctors, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.) 8. Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive 9. Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency 10. Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 50.0-999.0, Aging Fall years of age or older Can exercise with minimal supervision (cleared for physical activity) Can commit to a 12-week exercise program (2 sessions/week) Under 50 years of age Not cleared to perform physical activity | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 35.0-75.0, Renal Transplantation Aging are group specific. HBV, HCV and HIV testing are not necessary in the RT groups as all RT recipients are tested prior to transplant. The investigators will not restrict volunteers with respect to gender, ethnic or racial group. Groups 1 (65-75 yrs) and 2 (35-45 yrs) Renal Transplant populations End stage renal disease cause either DM2 and/or hypertension (HTN) Renal transplant >12 months ago Group 3: Diabetic/hypertensive 65-75 year old controls With DM2 and/or HTN Previous immunization with PPV23 >1 year prior Willingness to be tested for HIV, HBV and HCV "normal kidney function" defined as glomerular filtration rate (GFR) of 60% or above Group 4: Healthy Control 65-75 yr old Without DM2 May have high blood pressure (systolic>140 and/or diastolic>90) as long as it is well controlled (systolic<140 and/or diastolic <90) and has not affected kidney function Previous receipt of PPV23 > 1 year prior are either applicable to all groups or group specific. Therefore we have listed the applicable to ALL groups first. Group specific are listed under each group common to all groups Previous immunization with PCV13 Pregnancy, no contraceptive practice in women of childbearing age, or breastfeeding Known anaphylaxis, hypersensitivity or "bad allergic reaction" to the pneumonia vaccine. This does not egg allergy or previous Guillan Barre syndrome Those who received blood products or gamma globulin within 3 months Inability to comprehend or sign the informed consent form Previous/present illness that may affect immune response to the vaccine previous pneumococcal disease | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Diabetes Mellitus, Type 2 Signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) Male or female, age more than or equal to 18 years at the time of signing informed consent (in Algeria more than or equal to 19 years; in Japan more than or equal to 20 years) Diagnosed with T2DM more than or equal to 180 days prior to the day of signing the informed consent Previous participation in this study. Participation is defined as having given informed consent in this study Diagnosed with Type 1 diabetes Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation Patients with known congenital heart disease/malformation | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Influenza Healthy adults between the ages of 18-70 years inclusive 2. Based on history and examination, in good general health and without history of any of the conditions listed in the Received at least one licensed influenza vaccine from 2014 to the present 4. Able and willing to complete the informed consent process 5. If enrolled in Group 1: Available for clinic visits for 52 weeks after enrollment and through an influenza season 6. If enrolled in Group 2A, 2B, 2C, or 2D: Available for clinic visits for 68 weeks after enrollment and through an influenza season 7. Willing to have blood samples collected, stored indefinitely, and used for research purposes 8. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process 9. Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) less than or equal to 40 within the 28 days before enrollment Laboratory within 28 days before enrollment 10. White blood cells (WBC) and differential either within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval 11. Total lymphocyte count greater than or equal to 800 cells/mm^3 12. Platelets = 125,000 000/mm3 13. Hemoglobin within institutional normal range 14. Serum iron either within institutional normal range or accompanied by the site PI or designee approval 15. Serum ferritin within institutional normal range or accompanied by the site PI or designee approval 16. Alanine aminotransferase (ALT) less than or equal to 1.25 x institutional upper limit of normal (ULN) 17. Aspartate aminotransferase (AST) less than or equal to 1.25 x institutional ULN 18. Alkaline phosphatase (ALP) <1.1 x institutional ULN 19. Total bilirubin within institutional normal range 20. Serum creatinine less than or equal to 1.1 x institutional ULN 21. Negative for HIV infection by an FDA-approved method of detection applicable to women of childbearing potential: 22. Negative beta-human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on the day of enrollment 23. Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study Breast-feeding or planning to become pregnant during the study. Subject has received any of the following substances: 2. More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment 3. Blood products within 16 weeks prior to enrollment 4. Live attenuated vaccines within 4 weeks prior to enrollment 5. Inactivated vaccines within 2 weeks prior to enrollment 6. Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study 7. Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule 8. Current anti-TB prophylaxis or therapy 9. Previous investigational H1 influenza vaccine 10. Previous investigational ferritin-based vaccine 11. Receipt of a licensed influenza vaccine within 6 weeks before trial enrollment Subject has a history of any of the following clinically significant conditions: 12. Serious reactions to vaccines that preclude receipt of study vaccinations as determined by the investigator 13. Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema 14. Asthma that is not well controlled 15. Diabetes mellitus (type I or II), with the exception of gestational diabetes 16. Thyroid disease that is not well controlled 17. Idiopathic urticaria within the past year 18. Autoimmune disease or immunodeficiency 19. Hypertension that is not well controlled (baseline systolic > 140 mmHg or diastolic > 90 mmHg) 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 history of 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(SqrRoot)(Copyright) Syndrome 25. 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 subject s ability to give informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-80.0, Stage 4 Chronic Kidney Disease Patients with diabetic nephropathy in stage 4 chronic kidney disease Patients in pre-dialysis Patients with signed informed consent forms Patients who have received Ketosteril previously Patients participating in other intervention studies Pregnant women Patients with background of renal transplant Patients with cancer, HIV, seropositive for hepatitis B or C or receiving immunosuppressors, hypercalcemia Intolerance of Ketosteril ingredients Hereditary disorders in amino acid metabolism | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Permanent Chemotherapy-induced Alopecia Patients with a clinical diagnosis of permanent chemotherapy-induced alopecia who completed chemotherapy ≥ 6 months from the date of registration Patients must be age ≥ 18 years Females of child-bearing potential (FOCBP) and males must agree to use adequate contraception (e.g., hormonal contraceptives such as birth control pills, patch, intrauterine device; barrier contraception such as male/female condoms, diaphragm; male partner with vasectomy; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a female patient become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following Has not undergone a hysterectomy or bilateral oophorectomy Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months) FOCBP must have a negative urine or serum pregnancy test within 7 days prior to registration on study Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration in the study Patients receiving any other investigational agents or using other alopecia treatments in the past 3 months are not eligible Patients currently undergoing systemic cancer treatment or within 6 months of finishing chemotherapy are not eligible. Note: Patients receiving hormone modulators are eligible Patients who have pheochromocytoma, hypothyroidism, anemia, cutaneous GVHD, hypotension, or a history of hypersensitivity to any components of the drug preparation are not eligible Patients who have other forms of alopecia besides PCIA (with the exception of female pattern Ludwig 1 alopecia) are not eligible Patients on oral or injectable anticoagulants are not eligible to participate in the optional punch biopsy Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible: (Uncontrolled Hypertension, Ongoing or active infection requiring systemic treatment, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Pericardial effusion, Psychiatric illness/social situations that would limit compliance with study requirements, Patients with any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints.) Patients currently taking guanethidine are not eligible. Patients may participate after a 1-week washout period Patients currently taking drugs that may enhance the hypotensive effect of minoxidil are not eligible. Please contact study team regarding specific drug as washout period, as this will vary. Note: This includes: Alfuzosin, Amifostine, antipsychotic agents, Atazanavir, barbiturates, Benperidol, Brimonidine, Dapoxetine, Diazoxide, DULoxetine, Levodopa, Lormetazepam, Molsidomine, Naftopidil, Nicergoline, Nicorandil, Nitroprusside, Obinutuzumab, Pentoxifylline, phosphodiesterase 5 inhibitors, Probenecid, prostacyclin analogues, Quinagolide, and Valproate. If a patient is currently taking any of these drugs, further evaluation will be required to determine eligibility Female patients who are pregnant or nursing are not eligible Patients who have any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the patient's participation in the study are not eligible | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 60.0-999.0, Quality of Life Aging No medical contraindications to be involved in the exercise programs To be able to follow the exercise classes Signed informed consent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Pain Management Any patient undergoing laparoscopic hysterectomy Benign indications Dr. Jamal Mourad or Dr. Nichole Mahnert will be performing hysterectomy Non-English speakers History of chronic opioid use History of epilepsy History of claustrophobia Have received a prescription or taken opioids within 2 weeks for their scheduled surgery | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 16.0-999.0, Pregnancy Related Immunization; Infection Pertussis Pregnant and not yet having received pertussis vaccination Willing and able to comply with study procedures and provide informed consent Documentation of a 20-week anomaly scan with no life limiting congenital anomalies identified Age less than 16 years Confirmed or suspected pertussis in previous five years Known diagnosis of immune deficiency Receiving immunosuppressive medication within six months of enrolment in the study (this does not inhaled or topical steroids) In the opinion of the investigator is unlikely to complete follow up | 0 |
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