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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): 18.0-49.0, Influenza Male or female aged 18 years Give written informed consent Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations Females should not be pregnant and not lactating and fulfill one of the following At least one year post-menopausal;Surgically sterile;Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after vaccination Willing to use another reliable form of contraception approved by the Investigator for study duration and until 28 days after vaccination Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits Willing to receive the unlicensed (VAX161) vaccine given as an i.m. injection Willing to provide multiple blood specimens collected by venipuncture | 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, Hypertension Caucasian patients aged 18-80 years History of any grade of hypertension for at least 1 year, including at least 3 months of constant antihypertensive medication (consisting of ≥ 1 antihypertensive drugs, each administered in one dose daily), with reasonably controlled BP (≤150/90 mmHg and ≥ 115/75 mmHg on usual medication) based on previous clinic records, in the last 3 months BP levels > 150/90 mmHg or < 115/75 mmHg in the last 3 months Postural hypotension, defined as symptoms resulting from a > 20 mm Hg drop of systolic BP or a > 10 mm Hg drop of diastolic BP or both between 1 and 3 min after standing from the sitting position Known Extreme dippers at baseline (fall of mean night time SBP > 20% of mean day time SBP) Individuals with jobs which require night-time shift work Pregnant women or those planning to become pregnant | 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): 19.0-999.0, HIV Infection Adult men and women aged 19 years or over 2. HIV positive by ELISA and Western blot, at least 3 months prior to screening 3. No antiretroviral therapy within 3 months prior to screening 4. Plasma HIV RNA (viral load) > 2,500 copies/mL at screening 5. Current CD4 cell count >350 cells/mm3 at screening 6. Adequate renal function as demonstrated by eGFR >60 mL/min. at screening Pregnancy or breast-feeding 2. Any HIV-associated symptom or condition (e.g. nephropathy) for which standard antiretroviral therapy is indicated immediately 3. History of peptic ulcer and/or gastrointestinal bleeding 4. Allergy to ASA, other salicylates, or NSAIDs 5. Currently receiving treatment with an ACE inhibitor, ASA, anticoagulants, antacids containing aluminum hydroxide, cyclosporine, diuretics, systemic glucocorticoids, lithium, methotrexate, or other NSAIDs 6. Significant hepatic impairment or active liver disease screening AST, ALT, or bilirubin >2.5x upper limit of normal (ULN) 7. Hyperkalemia screening serum potassium >5.5 mmol/L 8. Anemia screening hemoglobin <85 g/L | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Subject is ≥ 18 years of age on the day of Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures History of serious adverse reaction to any influenza vaccine Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Prior vaccination with any 2012 formulation of influenza vaccine Known systemic hypersensitivity to eggs, chicken proteins, latex, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) Receipt of immune globulins, blood, or blood-derived products in the past 3 months Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Influenza Aged 18 through 64 years on the day of Informed consent form (ICF) has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination Vaccination against influenza in the past 6 months 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 | 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, Consequences of Immunization Method healthy adults without latex allergy over 18 years of age latex allergy illness years or less | 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): 18.0-80.0, Parkinson's Disease Patients with Parkinson's disease Age between 18-80 years Patients signed the consent form Patients with atypical parkinsonism | 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, Vestibulodynia non pregnant women between 18-35 naïve to HCs or other hormonal medications Patients able to provide Informed Consent and complete questionnaires Patient intends to use HCs for at least one year On exam before initiation of HCs, patient does not have primary PVD, pelvic floor hypertonicity, vaginismus or congenital abnormalities Patient will be available for follow up appointments Patient is willing to undergo gynecologic examination, if dyspareunia develops Patients with endocrine disturbances (including PCOS), liver diseases and eating disorders Patients who suffer from Hypertension, Migraine with aura or clotting disturbances Patients that experience pain with intercourse or tampon insertion Patients that have other contraindications for HCs use | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-60.0, Influenza Age greater than or equal to 18 years and less than or equal to 60 years 2. Body mass index (BMI) of 19-32 kg/m(2) 3. Estimated glomerular filtration rate greater than or equal to 90 mL/min at screening, calculated using the MDRD formula 4. Subjects must agree to Not take any prescription or OTC medications with the exception of Tylenol, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior and during study drug administration Not consume any alcohol for a period 2 days prior to and during study drug administration. 5. One of the following in order to avoid pregnancy Females who are able to become pregnant (i.e., are not postmenopausal) have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception From the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug Any chronic medical problem that requires daily oral medications (except Tylenol, oral contraceptives, vitamins, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a phase I drug. 2. History of cardiovascular disease or unexplained syncope 3. Women who are breast-feeding. 4. Positive urine or serum pregnancy test. 5. Abnormal ECG -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table. --evaluating PR interval, QTc interval and rhythm. 6. Abnormal chemistry panel -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table --evaluating only sodium [Na], potassium [K], serum bicarbonate [total CO2], creatinine, glucose,albumin, ALT, AST, ALKP, GGT, total bilirubin, LDH, and estimated GFR by the MDRD equation. 7. Abnormal complete blood count (CBC) -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table - evaluating only the WBC (to absolute neutrophil and lymphocyte counts), hemoglobin, hematocrit, and platelets. 8. Abnormal urinalysis -defined as any clinically significant baseline Grade 1 or greater toxicity --evaluating only protein, and RBCs. 9. Urine-albumin-to-creatinine ratio (UACR) >30 mg/g. 10. Positive serology for Hepatitis B surface antigen. 11. Positive serology for Hepatitis C. 12. Positive serology for HIV-1. 13. Positive urine drug screen. 14. Participation in a study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0) 15. Donation of blood or blood products within 30 days or plasma within 2 weeks prior to study drug administration (i.e., Day 0) 16. Receipt of blood products within 2 months prior to study drug administration (i.e., Day 0) 17. Receipt of any vaccination within 30 days prior to study drug administration (i.e., Day 0) 18. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject s ability to complete and/or participate in this clinical study | 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): 0.0-0.154, Infantile Colic otherwise healthy infants crying/fussing more than three hours/day more than three days in the same week has tried cow´s milk protein free diet for at least five days born before week 36 has tried acupuncture treatment dont gain weight properly taking other medicine than dimethicone or lactobacillus reuteri parents who don´t understand Swedish | 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, Infection in Solid Organ Transplant Recipients Solid organ transplant recipient. 2. 16 years or older. 3. More than 30 days after transplantation. 4. Negative pregnancy test for women of childbearing potential 5. The patient must give informed consent No written informed consent. 2. Acute rejection within 15 days prior to vaccination. 3. Pregnancy. 4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins. 5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome) | 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, Hepatocellular Cancer Histologically confirmed advanced HCC Barcelona Clinic Liver Cancer stage C or stage B if you cannot tolerate or failed TACE No cirrhosis or Child-Pugh A cirrhosis Measurable lesions All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 grade 1 or less Able to swallow and retain oral medication Prior systemic regimens for HCC Uncontrolled hypertension CLIP score > 3 ECOG PS > 1 Clinically apparent central nervous system metastases or carcinomatous meningitis Pregnant or breastfeeding Active or clinically significant cardiac disease Evidence or history of bleeding diathesis or coagulopathy Any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of enrollment Presence of a non-healing wound, non-healing ulcer, or bone fracture | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-64.0, Influenza Main 1. Provide written informed consent 2. Males or females aged 18-64 years, inclusive 3. Symptomatic presumptive influenza A or B infection defined as the presence of: 1. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND 2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND 3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion) 4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred: 1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR 2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR 3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) Main Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening 2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks. 3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma 4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months 5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants 6. Presence of clinically significant signs of acute respiratory distress during screening 7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study. 8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min 9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results | 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): 22.0-35.0, Nutritional Anemia in Mothers. Nutritional Anemia in Infants. Hb level in the range of 7.0-11 g/dL 2. Age: 22-35 years 3. Mothers at the beginning of second trimester (i.e. at 11-14 weeks of gestation) 4. Willing to stay in Dhaka during pregnancy and willing to get admitted in the clinic for delivery 5. Self-reported Last Menstrual Period (LMP) and urine pregnancy test will be used to determine the gestational age Women with severe anemia; hemoglobin concentration <7.0 g/dL 2. History or presence of systemic disease 3. H/O of previous complicated pregnancies or of pre-term delivery, abortion 4. Receipt of influenza 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): 18.0-85.0, Pruritus Patients w/ histologically confirmed mycosis fungoides stage IB to IVA eligible to receive oral vorinostat Patients w/ stage IB to IV reporting pruritus Patients age 18-85 years, of any race, sex, and ethnicity Life expectancy > 24 weeks Patient must have performance status of ≤2 on the ECOG Performance Scale Patients w/ a min. of 3 weeks since their last systemic treatment Women who are not pregnant, lactating, or of childbearing potential Female patients w/ reproductive potential must use an adequate contraceptive method during treatment and for three months after completing treatment Male patient w/ reproductive potential, agrees to use an adequate method of contraception for the duration of the study and for 30 days beyond the duration of study Patients, or legal representative must to be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study Patients w/ a recent cardiac history, such as a myocardial infarct within the last year, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities Patients w/ a history of liver damage (2.5 x normal ALT, AST), leukopenia, or thrombocytopenia Women who are pregnant or nursing a child Patients w/ severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen Patients who have received and histone deacetylase inhibitor within the last 6 months Patients receiving valproic acid will be excluded unless there has been a wash-out period of 30 or more days Patients who will have received systemic therapy, radiation therapy or phototherapy within 3 weeks prior to initial dosing with study drugs or who has not recovered from adverse events due to agents administered more than 3 weeks earlier QTc prolongation greater than 500ms Patient w/ a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse | 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): 45.0-999.0, This Study Has Been Designed to Compile Information on the Efficacy of the Partial Breast Intracavitary Brachytherapy in the Post Market Setting. Be 45 years of age or older Be a Tis, T1, N0 M0 American Joint Committee Classification Have negative surgical margins (NSABP definition) after final surgery Should have adequate skin spacing between balloon surface and surface of the skin (>=7mm) DCIS Be pregnant or breast-feeding.(If appropriate, patient must use birth control during the study) Have collagen-vascular disease Have extensive intraductal component (Harvard Definition,>25% DCIS) Have infiltrating lobular histology | 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, Influenza Age 18-30, 60-79, or 80-100 years, inclusive at time of initial enrollment General good health and ambulatory at time of enrollment No acute illness at time of vaccination Willing and able to sign Informed Consent Available for follow-up for the planned duration of the study Acceptable medical history by screening evaluation and brief clinical assessment All female subjects of childbearing potential must use an acceptable method of contraception and not become pregnant for the duration of the clinical phase of the study (approximately 1 month to completion of Visit 3). (Acceptable contraception may implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner) Prior off-study vaccination with trivalent or quadrivalent (depending no year) influenza vaccine (TIV or IIV4) or live attenuated influenza vaccine (LAIV) in the current flu season Allergy to egg or egg products Allergy to vaccine components, including thimerosal Active systemic or serious concurrent illness, including febrile illness on the day of vaccination History of immunodeficiency Any chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol Blood pressure >150 systolic or > 95 diastolic at Visit 1 Chronic Hepatitis B or C Recent or current use of systemic immunosuppressive medication, including glucocorticoids (corticosteroid nasal sprays and inhaled steroids are permissible). Use of oral steroids (<20mg prednisone-equivalent/day) may be acceptable after review by the investigator 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 | 2 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.126-0.208, Neisseria Meningitidis Bacterial Infections Virus Diseases Healthy infant 46 to 74 days (both inclusive) Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth Parent(s)/legal representative able to comply with the study procedures Participation in any study with an investigational compound or device since birth History of congenital or acquired immunodeficiency Chronic illness that could interfere with study conduct or completion Hypersensitivity to any of the study vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® History or maternal history of HBsAg seropositivity Coagulation disorder that contraindicate intramuscular injection History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s) History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection Receipt of immune globulin, blood or blood-derived products since birth | 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, Breast Cancer HER2-positive Stage I histologically confirmed invasive carcinoma of the breast ER/PR determination is required HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0 Bilateral breast cancers that individually meet are allowed Subjects with multifocal or multicentric disease are eligible as long as each tumor individually meets Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing Less than or equal to 90 days since most recent breast surgery for this breast cancer All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection All margins should be clear of invasive cancer or DCIS Pregnant or breastfeeding Use of potent CYP3A4 inhibitors during the study treatment period Excessive alcohol intake (more than 3 alcoholic beverages per day) Locally advanced tumors at diagnosis History of previous invasive breast cancer History of prior chemotherapy in the past 5 years History of prior trastuzumab or prior paclitaxel therapy Active, unresolved infection Active liver disease History of a different malignancy except for the following: disease free for at least 5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous cell carcinoma of the skin | 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, Pain for Patients: 1. Patient must be greater than or equal to 18 years of age. 2. Patient must be able to comprehend English. 3. Patient must be able to provide written informed consent. 4. Patient must have had chronic widespread pain for at least one year prior to participation with an average daily intensity at least 4 out of 10. for Healthy Controls: 1. Healthy control must be greater than or equal to 18 years of age 2. Healthy control must be able to comprehend English. 3. Healthy control must be able to provide written informed consent for patients: 1. Patient is unable to comply with study procedures or follow-up visits 2. Patient smokes more than 10 cigarettes of nicotine per week. 3. Patient uses recreational drugs. 4. Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks per week. Further, patient consumes more than 5 drinks at one time. 5. Patient is pregnant or breastfeeding. 6. Patient has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition. 7. Patient has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts. 8. Patient has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have. 9. Patient is uncomfortable in small closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine. 10. Patient cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI scanner. 11. Patient has allergies to topical treatment. 12. Patient has a chronic pain condition other than FM. 13. Patient has taken within the last two weeks opioids. Other medications used to treat fibromyalgia at the standard doses in the community can be taken. We will not ask participants to stop any medication to participate in the study. 14. Patient has previously taken opioids for more than one month on a continual basis, within the last 6 months. 15. Patient had seen study information on clinicaltrials.gov prior to September 23, 2013. 16. Patients who decline to be audio and/or videotaped will be excluded from the qualitative interview component of the study for healthy controls: 1. Healthy control is unable to comply with study procedures or follow-up visits 2. Healthy control smokes more than 10 cigarettes of nicotine per week. 3. Healthy control uses recreational drugs. 4. Female healthy control consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male healthy control consumes 14 such drinks per week. Further, healthy control consumes more than 5 drinks at one time. 5. Healthy control is pregnant or breastfeeding. 6. Healthy control has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition. 7. Healthy control has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts. 8. Healthy control has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments | 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, Psoriasis Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Be at least 18 years of age at time of informed consent. 4. Have had a diagnosis of plaque-type psoriasis (psoriasis vulgaris). 5. Subject is about to start a new kind of therapeutic treatment, either topical, phototherapy, systemic, or biologic agent Subject is not over 18 years of age. 2. Subject cannot understand or follow directions. 3. Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control. 4. Subject is pregnant or planning to get pregnant | 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): 12.0-60.0, Influenza, Human Immunisation Reaction aged 12-60 years old male or non-pregnant female volunteers received 2010 seasonal influenza vaccine clinically healthy as determined by: medical history inquiring and physical examination provide written informed consents before joining the trial without history of 2010 seasonal influenza vaccine administration allergic to any ingredient of vaccine autoimmune disease or immunodeficiency severe adverse reaction after vaccination, such as allergies, hives, breathing difficulties, angioedema or abdominal pain severe acute and chronic diseases axillary temperature over 37.0℃ at the time of 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): 18.0-64.0, H7N9 Influenza Healthy adult subject ages 18-64 years. 2. Individuals willing to provide written informed consent 3. Individuals in good health. 4. Individuals who can comply with study procedures and follow-up Individuals with history of cognitive or behavioral impairment or psychiatric disease, 2. Individuals unable to understand and follow study procedures, 3. History of significant illness, 4. History of chronic medical condition or progressive disease, 5. Allergy to any vaccine component or adverse event related to a vaccine component, 6. Impairment/alteration of the immune system, 7. Presence of progressive or severe neurological disorder, 8. Pregnant or breast-feeding, 9. Female of Child-bearing potential unwilling to use acceptable method of birth control, 10. Presence of medically significant cancer, 11. Receipt of investigational product within 30 day prior to entry into the study, 12. History of previous or suspected illness from avian flu caused by H7N9 virus, 13. History of H7 vaccination, 14. Body temperature of greater than or equal to 38.0°C (100.4◦F) and/or acute illness within 3 days of intended study vaccination, 15. Receipt of any flu vaccination 2 weeks before study entry or 4 weeks after study vaccination, 16. Receipt of any vaccination 2 weeks before study entry or 4 weeks after study vaccination, 17. History of drug or alcohol abuse within the past 2 years, 18. Body Mass Index (BMI) greater than or equal to 35kg/m2, 19. Individuals conducting the study or their immediate family members | 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): 12.0-50.0, Urticaria Clinical diagnosis of persistent allergic urticaria Age over 12 years and at least one year with the disease Informed consent filled Be resident of the metropolitan area of Medellin • Use of immunosuppressive 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, Influenza Subject is ≥ 18 years of age on the day of Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures History of serious adverse reaction to any influenza vaccine Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Prior vaccination with any 2013-2014 formulation of influenza vaccine Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) Receipt of immune globulins, blood, or blood-derived products in the past 3 months Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine | 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): 65.0-999.0, Influenza Male or female adults who are 65 years of age and older at the time of first study vaccination Written informed consent obtained from the subject Subjects who the investigator believes can and will comply with the requirements of the protocol Stable health status, as established by medical history and physical exam, and defined by absence of a health event satisfying the definition of a serious adverse event, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrollment Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device Presence or evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence or evidence of substance abuse Diagnosed with cancer, or treatment for cancer within three years Persons with a history of cancer who are disease-free without treatment for three years or more are eligible Persons with a history of histologically-confirmed basal cell carcinoma of the skin successfully treated with local excision only are excepted and are eligible, but other histologic types of skin cancer are exclusionary Women who are disease-free three years or more after treatment for breast cancer and receiving long-term prophylaxis are eligible Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least one month), or narcolepsy; or history of narcolepsy in subject's parent, sibling or child Presence of a temperature ≥ 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection Receipt of systemic glucocorticoids within 30 days prior to the first dose of study vaccine/placebo, or any other cytotoxic, immunosuppressive or immune-modifying drugs within 6 months of first study vaccine/placebo dose. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed | 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 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): 7.0-999.0, Type 1 Diabetes Type 2 Diabetes for A subject is eligible for the user evaluation study if all of the following are met: 1. Subject is 7 years or older at time of screening 2. Subject is current insulin pump user for at least 3 months 3. Subject has the following CGM experience as determined by the Investigator Has experience and is able to insert/change sensor by herself/himself and Has experience and can recharge the transmitter and Has experience and can read sensor data in real-time on her/his pump screen 4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures; 5. Subject is willing to complete study questionnaires throughout the study 6. Must have the following clinical diagnosis: 1. Type 1 diabetes, for a minimum of 6 months prior to enrollment for A subject is excluded from the user evaluation if any of the following are met: 1. Female subject has a positive urine pregnancy screening test. 2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn 3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures. 4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff 5. Subject is unable to tolerate tape adhesive in the area of sensor placement 6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection) 7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled 8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this | 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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-40.0, Allergy age>4 years old IgE mediated allergy to milk eggs or peanuts Completion of OIT >6 months ago Non approval to participate | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Healthy Subject Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer. 2. Both males and females are eligible. 3. Members of all racial and ethnic groups are eligible. 4. Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B). 5. No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix 6. No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A) 7. No chronic anticoagulation 8. No chronic use of steroids 9. Karnofsky Performance Scale ≥90% (Appendix C) 10. Able to provide written, informed consent 11. For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention 12. No history of food intolerance to broccoli or pineapple and lime juices 13. Willing to avoid cruciferous vegetables during the study interventions (Appendix D) 14. Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study 15. Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study 16. Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation Failure to meet the above | 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, Spinal Cord Injury Bone Loss Osteoporosis Enrollment in, and completion of one year of treatment, in protocol "Effect of Teriparatide, Vibration and the Combination on Bone Mass and Bone Architecture in Chronic Spinal Cord Injury" Adherence rate for teriparatide use of ≥60% Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential 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; 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) Ability to understand and the willingness to sign a written informed consent Individuals who could not tolerate teriparatide treatment Individuals who will not be able to return for all study visits Patients may not be receiving any other investigational agents Other medical conditions that in the opinion of the investigator would preclude the subject from completing 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): 18.0-70.0, Menopause Aging age established for pre-, peri and postmenopausal women, and if postmenopausal at least 1 year beyond menopause resting blood pressure <140/90 mmHg 81; 2) plasma glucose concentrations <110 mg/dl under fasting conditions sedentary or recreationally active (<3 days of vigorous aerobic exercise) no use of OCs, HT, or other medications that might influence cardiovascular function nonsmokers no use of vitamin supplements, or willing to stop use for duration of the study not taking any other medications that would interact with cetrotide, E2 patch, or Kuvan® to confound interpretation of results history of or active estrogen-dependent neoplasms, acute liver or gallbladder disease, vaginal bleeding, venous thromboembolism, hypertriglyceridemia, and CVD known allergy to transdermal patch, GnRHant (i.e., hypersensitivity to cetrorelix, extrinsic peptide hormones, mannitol, GnRH, benzyl alcohol the vehicle for injection of cetrorelix), or KUVAN history of stomach ulcer or bleeding other contraindications to HRT, GnRHant, and KUVAN (i.e., taking Levodopa, medications that can inhibit folate metabolism including methotrexate) pregnant or currently breastfeeding Other conditions for which individuals will be excluded from the study diabetes, active infection, history of seizures or disease that affects the nervous system, sepsis or an abnormal resting ECG | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 8.0-999.0, Diet Modification Chronic Urticaria Urticaria +/ angioedema present for a minimum of 6 weeks Agree to be on anti-histamine prn Age older than 8 years old, with no upper age limit Causes such as parasite infestation, microbial and viral infections, autoimmune disease, or other pathology that could account for the U/A/P should be excluded Skin prick test and/or radioallergosorbent (RAST) test are negative for all food allergens tested, or patient had achieved no symptomatic improvement after strict avoidance of all skin test-positive foods Pregnant or breast feeding women Patients who is taking central nervous system (CNS) acting agents (including tranquilizers, antidepressants, sedatives, hypnotics or antiepileptics) at any time | 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 Viral Illnesses: Influenza A/B, RSV, Adenovirus Sample from patients exhibiting signs/symptoms of respiratory viral infection All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor Samples that are incorrectly de-identified | 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, Chronic Genotype 4 HCV Chronic Genotype 5 HCV HCV RNA ≥ 10^4 IU/mL at screening Chronic genotype 4 or 5 HCV Infection Individuals may be treatment naive or treatment experienced Presence or absence of cirrhosis, a liver biopsy may be required Healthy according to medical history and physical examination with the exception of HCV diagnosis Agree to use two forms of highly effective contraception for the duration of the study History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors History of any other clinically significant chronic liver disease Evidence of or history of decompensated liver disease HIV or chronic hepatitis B (HBV) infection Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers) Chronic use of immunosuppressive agents or immunomodulatory agents | 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, Tinnitus years of age History of chronic subjective tinnitus that cannot be attributed to vascular, neurologic, neoplastic or traumatic causes Capable of self-applying the lidocaine patches History of heart disease History of irregular heartbeat Prior MI Previous exposure to lidocaine as a treatment for tinnitus An allergy to adhesives Allergy to lidocaine Taking medications, herbal remedies and supplements that may interact with lidocaine, including but not limited to antivirals, benzodiazepines, and St. John's Wart Known liver disease Known kidney disease Adults who do not speak English | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-70.0, Dialysis Healthy Subjects Cytomegalovirus Infection Main for Healthy Subjects Body Mass Index (BMI) range of 18.5 0 kg/m2; weighs at least 50 kg at Screening Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 28 days after final injection Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final injection Highly likely to comply with the protocol and complete the study Estimated creatinine clearance calculated using the Cockcroft-Gault equation of > 80 mL/min/1.73m2 (normal renal function). for Dialysis Patients BMI range of 18.5 0 kg/m2; weighs at least 50 kg at Screening Female subject must not be lactating and must not be breast feeding within 3 months before Screening or during the study period and for 30 days after final injection Main Healthy Subjects Female subject is pregnant at Screening Any clinically significant history of allergic conditions (including drug allergies, asthma, eczema, or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) Any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal (for healthy subjects only) and/or other major disease or malignancy (except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been handled by local surgery) History or evidence of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis, scleroderma, psoriasis, psoriatic arthritis and inflammatory bowel disease Febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (non-cutaneous) infection within 1 week prior to day -14 Any of the liver function tests (LFT) (aspartate amino-transferase [AST] or alanine aminotransferase [ALT] alkaline phosphatase (ALP), gamma-glutamyl transferase [GGT], total bilirubin [TBil]) outside of normal limits at Screening Mean pulse < 40 or > 90 beats per minute (bpm), mean systolic blood pressure (SBP) > 160 mmHg or mean diastolic blood pressure (DBP) > 90 mmHg taken in triplicate after the subject has been resting in a sitting position for at least 5 minutes at Screening Positive serology test for hepatitis B surface antigen (HBsAg) or hepatitis core immunoglobulin M (HBc [IgM]) antibody, anti-hepatitis A virus (HAV) IgM or anti-human immunodeficiency virus type 1 and type 2 (HIV-1 and HIV-2) at Screening Positive serology test for anti-hepatitis C virus (HCV) and a confirmatory positive reflex viral load test at Screening | 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, Infection For Initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy. Patients with persistent JC virus infection will be eligible as well. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. 2. Treatment of the following persistent or relapsed infections despite standard therapy; 1. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx Failure of antiviral therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy. 2. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or nasopharynx Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 3. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor EBV infection: defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR,Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood Failure of therapy is defined as: Increase or less than 50% response at sites of disease for EBV lymphoma OR, Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab. 4. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined. Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy. In small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. 2. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 3. Patients who are less than 28 days removed from their allogeneic hematopoieteic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days. 4. Patients with active acute GVHD grades II-IV. 5. Active and uncontrolled relapse of malignancy | 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, Blood Pressure Read, speak, and write English Premenopausal Consuming estrogen supplements Taking hypertensive blood pressure medication Consuming pumpkin seed oil supplements Consuming pumpkin seeds more than once a month Wheat allergy or gluten intolerance Blood pressure > 140/90 mmHg | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 8.0-999.0, Influenza Volunteers greater than or equal to 8 years of age Parental consent if a participant is less than 18 years of age Willing to have samples stored for future research Willingness to complete all study procedures Daily or nearly daily contact with swine during selected agricultural fairs Any medical condition or circumstance that may make it unsafe for the participant to have nasal swab performed | 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, Obesity Planning to undergo a Roux En Y Gastric Bypass or Sleeve Gastrectomy at Wake Forest Baptist Health Admission for a psychiatric event in the past year History of nausea and/or significant complaint of post-operative nausea History of stricture and/or significant complaint of post-operative stricture History of ulcer and/or significant complaint of post-operative ulcer History of major depression or psychiatric 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): 18.0-42.0, Pregnancy less than 29 weeks pregnant ages 18-42 planning to deliver at The Ohio State University Wexner Medical Center prior serious adverse reaction to seasonal influenza 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): 18.0-40.0, Influenza Healthy individuals aged 18-40 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015 You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after You had an allergic response or sensitivity to past vaccinations You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.) You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity Any history of gastrointestinal disease, kidney or liver diseases | 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, Renal Cancer Renal Cancer Other terminal illness | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Supply and Demand of Early Care and Education in the US Households with at least one child under the age of 13 Individuals who care for a child under 13 who is not their own in a home based setting for at least five hours a week Center-based ECE programs that provide care to children not yet in kindergarten who were identified from the provider sampling frame built from state or national administrative lists such as state licensing lists Respondents for the center-based workforce survey are selected from the list of instructional staff associated with the randomly selected classroom from the center-based provider interview | 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): 9.0-14.0, Childhood Obesity overall healthy, normal weight (between the 5th and 85th BMI percentile for age and gender) 9 to 14 year old boys and girls (peripubertal) born at term and at a normal birth weight, and does not receive any medications significant learning, behavioral, or emotional difficulties, restricted diet, food allergies to test treatments | 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): 75.0-999.0, Influenza Immunization Older Adults Over Age 75 Adults over age 75 years Allergies to egg or vaccine Active malignancies On radiation or chemotherapy Active systemic inflammatory diseases including rheumatoid arthritis, Crohn's disease, and ulcerative colitis Acute exacerbation of chronic cardiopulmonary conditions including decompensated CHF or COPD Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate) Lacking the capacity to consent (individuals who do not understand what Flu shot is or need someone else to decide if s/he should get the Flu shot) | 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): 0.0-18.0, Children Admitted to the Intensive Care Unit Any patient admitted to the Intensive Care Unit, or soon to be admitted to the ICU Age from 0 days to 17 years 364 days at the time of enrollment Any patient with anticipated ICU stay of at least overnight with a minimum of 12 hours duration Any patient with Admitted with Traumatic Brain Injury, Admitted with an Active Seizure Disorder, Severe Developmental Delay that might impair normal sleep architecture, Known abnormal EEG, any patient actively receiving Mechanical Ventilation | 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): 65.0-99.0, Avian 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 females, 65 years of age and older. 4. Are in good health1. 1As 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 that would affect the assessment of and safety of subjects. Chronic medical diagnoses or conditions being actively managed must be within acceptable limits in the last 180 days. Good health in the elderly is also defined as no change in chronic prescription medication, dose, or frequency of medication in the 90 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 does not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and first study vaccination are acceptable provided the subject is asymptomatic, condition stable, 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 steroids as outlined in the Subject (see Section 5.2)), herbals, vitamins, and supplements are permitted 5. Oral temperature is less than 100.0 degrees F. 6. Pulse is 50 to 115 bpm, inclusive. 7. Systolic blood pressure is 85 to 160 mm Hg, inclusive. 8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive Have an acute illness2, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination. 2An 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 participation3. 3Including acute or chronic medical disease or condition, defined as persisting 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 or the subject's successful completion of this study. 3. Reside in a nursing home4 or other skilled nursing facility or have a requirement for skilled nursing care. 4An ambulatory subject who does not require skilled nursing care and is a resident of a retirement home or community is eligible for this clinical trial. 4. Inability to provide informed consent or complete study activities, for example, due to dementia or other impairment. 5. 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. 6. Have known active neoplastic disease or a history of any hematologic malignancy. 7. Have known HIV, hepatitis B, or hepatitis C infection. 8. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine. 9. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines. 10. Have a history of Guillain-Barré Syndrome. 11. Have a history of neuralgia, paresthesia, neuritis, convulsions, or encephalomyelitis within 90 days prior to study vaccination. 12. Have a history of autoimmune disease5. 5Including, but not limited to, autoimmune processes resulting in neuroinflammatory diseases, vasculitis, clotting disorders, dermatitis, arthritis, thyroiditis, or muscle, liver, or kidney disease. 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 corticosteroids of any dose within 30 days prior to study vaccination. 17. Have taken high-dose inhaled corticosteroidswithin 30 days prior to study vaccination. High-dose defined as >800 mcg/day of beclomethasone dipropionate CFC or equivalent. 18. Received a licensed live vaccine within 30 days prior to enrollment in this study, or plans to receive a licensed live vaccine within 30 days before or after each study vaccine. 19. Received a licensed inactivated vaccine within 14 days prior to enrollment in this study, or plans to receive a licensed inactivated vaccine within 14 days before or after each study vaccine. 20. Received immunoglobulin or other blood products within 90 days prior to study vaccination. 21. Received an experimental agent6 within 30 days prior to the first study vaccination, or expects to receive an experimental agent7 during the 18-month study period. 6Including vaccine, drug, biologic, device, blood product, or medication. 7Other than from participation in this study. 22. Are participating or plan to participate in another clinical trial with an interventional agent8 during the 18-month study period. 8 Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 23. Prior participation in a clinical trial of influenza A/H7 vaccine9 or have a history of A/H7 actual or potential exposure or infection prior to the first study vaccination. 9And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients. 24. Plan to travel outside the US (continental US, Hawaii, and Alaska) within the 28 days following each study vaccination | 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): 1.0-18.0, Mental Retardation Cerebral Palsy cerebral palsy mental retardation Israeli Arab Israeli Jewish all others | 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, Squamous Cell Carcinoma of Skin Carcinoma, Squamous Cell Must have histologically or cytologically confirmed squamous cell carcinoma of the skin. Potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. Similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible Must have measurable disease, defined by Response according to Response Evaluation in Solid Tumors (RECIST) v1.1 as at least one lesion that can be accurately measured in at least one dimension of >10 mm by CT, MRI, or calipers There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. Prior topical treatment with 5-fluorouracil is permitted. Patients who are on chronic daily doses of prednisone of greater than 10 mg are excluded. There is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 21 days have passed since last administration Life expectancy of greater than 3 months Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60% Must have normal organ and marrow function Must not be candidates for curative locoregional treatments. Patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and 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 Ability to understand and the willingness to sign a written informed consent document Have had chemotherapy or radiotherapy within 21 days (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 3 weeks earlier May not be receiving any other investigational agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to either 5-FU/Capecitabine or Interferon Uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or breastfeeding Any heart or lung transplant patient on immunosuppressive agents. Renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis. Patients with Chronic Lymphocytic Leukemia (CLL) or other hematologic malignancies are allowed as long as they meet other listed above | 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, Autism Autistic children Healthy children Children with ADD All others | 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, Immediate Postpartum Hemorrhage The trial will women aged 18 years or older who have just had a vaginal delivery between 35 and 42 weeks of gestation with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data Patient beneficiary or affiliated to a health insurance The trial will not women who have just had a cesarean delivery with a contraindication to Sulprostone with clinical chorioamnionitis or an in utero fetal death or a medically-indicated termination of pregnancy with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta with arterial bleeding requiring embolization with a purulent infection of the cervix, vagina or uterus with symptoms indicating a hysterectomy with cervical cancer | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 6.0-999.0, Pulmonary Disease, Chronic Obstructive Patients of either sex, including children over 6 years Chronic obstructive respiratory tract disease. Every doctor was asked to in this study the first patients coming after each other, who were treated for the first time with Berodual® metered dose inhaler (MDI) Contraindications listed in the Instructions for Use/Summary of Product Characteristics of Berodual® metered-dose inhaler | 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, Exercise Promotion participants were were willing to attend an exercise class once a week for 12 weeks, were willing to complete questionnaires at baseline and 12 weeks, allowed the intervention staff to monitor their attendance at the YMCA for 6 months post intervention, and allowed the exercise instructor to create an audio recording of all of the intervention sessions not have any illnesses that would prevent them from exercising once a week, not be pregnant or planning to get pregnant within the next 3 months | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.25-4.917, Pneumonia Children admitted with severe pneumonia as defined by the presence of all the following as defined as below months to 59 months old History of cough and/or shortness of breath Unwell for <= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission Abnormal CXR with presence of alveolar infiltrates Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia- (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia - | 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): 0.083-999.0, Pulmonary Arterial Hypertension of Congenital Heart Disease The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for in the study must be signed by parents or legal guardians for minors, by the patient for adults The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its | 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, Cystic Fibrosis Lung Disease Newly diagnosed patients with Cystic Fibrosis (CF). Diagnosis of CF: at least one of the following three international accepted is fulfilled: i) sweat chloride ≥ 60mEq/L and/or ii) 2 CF-causing mutations in the CFTR gene and/or iii) changes typical for CF in the transepithelial potential difference in nasal or rectal epithelium. 2. Age and mode of diagnosis Early diagnosed (ED): Initial diagnosis following CF-NBS or for other reasons in the first 4 months of life (in preterms corrected age of 4 months) after January 1st, 2006. Other reasons could be prenatal diagnostics, meconium ileus or positive family history Late diagnosed (LD): Diagnosed after the fourth month of life due to clinical symptoms; initial diagnosis after January 1st, 2006 All patients are excluded who themselves or whose parents do not want to participate or that withdraw from the study; or those in whom the diagnosis of CF is unsure. Further are: 1. Preterms <30th week of gestation 2. Longer period of mechanical ventilation in first 3 months of life 3. A significant medical disease or condition other than CF likely to interfere with the child's ability to complete the entire protocol 4. Previous major surgery except for meconium ileus or atresia of the intestine 5. Other major organ dysfunction, excluding pancreatic or hepatic dysfunction or another condition due to CF 6. Physical findings that would compromise the safety of the subject or the quality of the study data as determined by investigator 7. Chronic lung disease other than CF (e.g. bronchopulmonary dysplasia) 8. History of adverse reaction to medication for sedation or known claustrophobia which lead to a displacement of the procedures in sedation until the child has recovered Clinically significant upper airway obstruction as determined by investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnoea) Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy | 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): 19.0-999.0, Cystic Fibrosis confirmed diagnosis of CF currently sedentary (<60 min/week of physical activity) stable clinical condition (no exacerbation in last 6 weeks) nasal surgery for polyposis in the past 2 years participating or have participated (in the past 30 days) in another clinical trial which can affect the outcomes of the proposed study unable to read/speak English recurrent pneumothorax (in the past 6 months) hemoptysis (hospitalized in the past 6 months) uncontrolled CF-related diabetes (HbA1c > 10%) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, Elderly Immune System Written informed consent provided by the participant 2. Age 20-40 years old with no underlying chronic diseases or age ≥65 years old 3. Willing to receive influenza vaccination 4. Older cohort has received their influenza vaccine for the previous influenza season - Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily) 2. Have not received influenza vaccination in the past or cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination 3. Participant has received a community available influenza vaccine for the approaching influenza season 4. Females who are pregnant at Visit 1 (a pregnancy test will be administered for all females of child-bearing potential) - | 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, Pregnancy Any healthy, non-pregnant, fertile woman between 18 and 45 years of age.(Part 1 and 2) Have not taken multivitamins or folic acid supplements in the past 6 months. (Part 1 and 2) Healthy women between 18 to 45 years of age.(For Part 3) Planning a pregnancy, or within the first 2 weeks of missing a menstrual period, or within the first 6 weeks of pregnancy.(Part 3) Have not taken multivitamins or folic acid supplements in the past 6 months.(Part 3) Have hypersensitivities to the ingredients in PregVit-folic 5® or PregVit®. (Part 1, 2 and 3) Have chronic medical conditions (i.e. hypertension, diabetes, epilepsy, irritable bowel syndrome, hypo/hyper-thyroidism, depression). (Part 1, 2 and 3) Chronic use (i.e. long-term, specifically prescribed dose) of oral medications (i.e. oral contraceptives, anticonvulsants, antibiotics, antidepressants).(Part 1, 2 and 3) Have a family history or previous pregnancy affected by NTDs.(Part 1, 2 and 3) Do not agree to the protocol.(Part 1, 2 and 3) | 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): 50.0-75.0, Improvement in Immune Cell Function in Elderly Humans generally healthy must have had at least one cold during the previous year age 50-75 must discontinue other dietary supplement use on arthritis medication on hypertension medication severe allergies compromised immune system high cholesterol, heart failure, angina, etc diagnoses of diabetes or metabolic 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): 25.0-69.0, Cancer of the Cervix Cervical Intraepithelial Neoplasia Australian residents with a cervix, aged 25-69 years who are attending for routine cervical screening. (Note: since April 2016 recruitment has been confined to the younger strata, i.e. women age-eligible for HPV vaccination aged at least 25 and born on or after 1st July 1980, as the recruitment target of the older cohort was met) Participants may have been previously enrolled in the Compass Pilot but must have been discharged to routine screening. Women may also be in follow-up management for a previous abnormality or unsatisfactory cytology Previous total hysterectomy (uterus and cervix) The presence of symptoms or signs for which cervical cancer must be excluded Currently undergoing treatment for cervical cancer Currently enrolled in the Compass Pilot Study | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Ambulatory males or females aged 18 years and over Able to provide written informed consent Willing and able to comply with the protocol for the duration of the study Not planning to have seasonal influenza vaccine within 2 months from the time of the first trial immunization Pregnant or lactating women Women of childbearing potential unless using a reliable and appropriate contraceptive method Receipt of another investigational agent within 28 days preceding initiation of treatment Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the subjects or 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): 1.0-21.0, Food Allergy Wheat Allergy Age 1 year to 21 years of any sex and any race Physician-diagnosed food allergy to wheat with convincing clinical history of food allergy to wheat AND a skin prick test positive to wheat (diameter of wheal 3 mm or greater than negative control) or a detectable serum food-specific IgE level (ImmunoCAP > 0.35 kUA/L) to wheat within the previous 12 months or at the time of entry into the study If no history of clinical reactivity to wheat, then a positive skin prick test to wheat (diameter of wheal 3 mm or greater than negative control) OR a detectable serum food-specific IgE level to wheat within the previous 12 months or at the time of entry into the study Patients who meet any of the following are eligible for enrollment as study participants if they meet all other but will not undergo a Recent (within one year) failed open OFC Positive to wheat at CHCO Recent (within one year) exposure to wheat resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing, respiratory compromise, hypoxia, hypotension) Written informed consent from parent/guardian and assent (when age appropriate) Willingness to submit specimen for laboratory serum IgE testing Willingness to submit lab specimen for ELISA testing Inability to discontinue antihistamines for skin prick testing and OFCs FEV1 value <80% predicted OR any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma, at the time of entry into the study Use of >500 μg/day fluticasone or equivalent Asthma requiring either hospitalization in the past year for asthma, or ER visit in the past 6 months for asthma Use of steroid medications (IV, IM or oral) for asthma in the following manners history of daily oral steroid dosing for >1 month during the past year, or steroid course/burst in the past 3 months (except for steroid dosing used in the treatment of an allergic reaction during the or steroid courses/bursts in the past 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): 18.0-999.0, Ebola Virus The for the study are broad reflecting the target population that would eventually receive an efficacious vaccine Informed consent Age greater than or equal to 18 years Likely to be in the surrounding area of the vaccination center for at least one year Fever greater than or equal to 38.0 degrees Celsius History of EVD (self-report) Current pregnancy (a negative urine pregnancy test is required for women of child-bearing potential) Breast-feeding an infant Any condition which would limit the ability of the participant to meet the requirements of 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): 4.0-80.0, Food Hypersensitivity Presence or absence of specific IgE to alpha-gal or peanut History of severe anaphylaxis allergy to cow's milk protein | 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, Ileostomy Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have normal to slightly red skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for applied patches (assessed by investigator) Currently receiving or have within the past 2 months received radio and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment Are pregnant or breastfeeding Having dermatological problems in the peristomal or abdominal area (assessed by investigator) Participating in other interventional clinical investigations or have previously participated in this investigation | 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, Empathy Food Allergy Employed at a quick-service restaurant Speaks English Work at a table-only establishment | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 20.0-999.0, Hypertension Step1 Over 20 years old Essential hypertensive patients who taking anti-hypertensive drugs during previous 1 month Step2 Patients does not taking Fimasartan Patient's medication satisfaction score under 4 Patients with secondary hypertension Patients with orthostatic hypotension who has sign and symptom Patients with known severe or malignancy retinopathy Patients with significant investigations; abnormal renal function Childbearing and breast-feeding women Patients with history of allergic reaction to any angiotensin II antagonist | 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, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women 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): 18.0-999.0, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery | 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): 18.0-99.0, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache | 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): 18.0-85.0, Inherited Cardiac Arrythmias Long QT Syndrome (LQTS) Brugada Syndrome (BrS) Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Early Repolarization Syndrome (ERS) Arrhythmogenic Cardiomyopathy (AC, ARVD/C) Hypertrophic Cardiomyopathy (HCM) Dilated Cardiomyopathy (DCM) Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy) Normal Control Subjects All patients and family members 18 years of age or older with inherited cardiac arrhythmias including LQTS, Brugada Syndrome (BrS), cathecholaminergic polymorphic ventricular tachycardia (CPVT) or early repolarization syndrome (ERS) are eligible for enrollment All enrolled patients will have undergone clinically indicated genetic testing Age <18 years >85 years pregnant women life-limiting co-morbidities immunocompromise | 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, Common Cold Upper Respiratory Tract Infections Clinical diagnosis of upper respiratory tract infection (URTI) Within 48 hours of onset Onset of URTI >48 hours On antibiotics Pregnancy History of chronic illness or immunosuppression Allergic rhinitis Unable to perform nasal irrigation and gargling Taking part in another medical 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): 0.0-999.0, Abdominal Aortic Aneurysms Diagnosed abdominal aortic aneurysm with indication for endovascular repair. 2. Intention to electively implant the Aorfix™ Stent Graft System Does not comply with the indications for Aorfix™ in the Instructions for Use (IFU). 2. Unwillingness or inability to comply with the recommended follow-up assessments according to the standards of care at the investigative site. 3. Unwillingness or inability to provide informed consent to both the Registry and the EVAR procedure. 4. Patients in whom Aorfix™ is being placed as a secondary procedure to a previous surgical or endovascular treatment of an AAA other than with another Aorfix™ graft | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 55.0-75.0, Healthy Volunteers Provide a signed written informed consent Age 55-75 inclusive ECG within normal limits Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2 Negative urine drug screen for selected drugs of abuse at screening Negative for hepatitis and HIV at screening Good general health, as determined by medical history, physical examination, and clinical laboratory testing Willingness to stay in the unit overnight for the duration of the study Consent for CSF collection (for those in CSF group) Current smokers, or ex-smokers with a remote history (> 100 pack/year) Clinically significant medical conditions History of ECG abnormalities Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing Signs of active pulmonary infection or other pulmonary inflammatory conditions, even in absence of febrile episodes, in the last 14 days History or presence of disease in the kidneys and/or heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs Malignancy, regardless of location Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis Investigational agents are prohibited one month prior to entry and for the duration of the trial Currently taking medications known to be CYP2C9 inducers (i.e. carbamazepine and rifampicin) | 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): 14.0-18.0, Food Allergy All cases and controls must be registered on ACIR as having had a first dose of any pertussis containing vaccine before age 16 weeks and during the period of time in which the transition between aP and wP vaccine occurred; birth dates within 1st Janurary 1997 and 31st December 1999 depending on the jurisdiction. Case Cases will be considered to have IgE-mediated food allergy on the basis of 1. a documented history of consistent clinical symptoms following ingestion of an implicated food, and 2. evidence of sensitisation to that food via either positive skin-prick test or elevated specific IgE to the implicated food, with onset after the first pertussis-containing vaccine but before age 15 years. IgE-mediated food allergy is defined as BOTH: 1. The clinical notes or clinical letter arising from the allergy consult must explicitly document the presence of one or more of the following features. Onset of at least one these features must be within 1 hour of ingestion of suspected food where this can reasonably inferred from statements such as "immediate", "within x mins" where x is <60 urticaria angioedema emesis vocal hoarseness persistent cough wheeze stridor collapse none | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Tobacco Smoking Pregnancy the woman presents for her first prenatal visit before 14-week gestation she is a smoker years or older (legal age for consent and for consuming tobacco in Romania) married or in a stable relationship phone service in the home or mobile phone willing to have the partner contacted for participation, upon brief explanation of the study partner declines participation upon phone recruitment attempt | 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): 19.0-45.0, Shift Work Type Circadian Rhythm Sleep Disorder Imbalance of Constituents of Food Intake Eligible participants were regularly employed by the hospital, with 36-hours per week scheduke, not counting additional shifts and overtime work Volunteers who did not supply the necessary information for the development of the research and who were pregnant or lactating | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 4.0-6.0, Bronchopulmonary Dysplasia Healthy Bronchopulmonary Dysplasia Children age between 4 to 6 years old Bronchopulmonary Dysplasia diagnostic ex-prematurity accept to participate congenital malformations neuromuscular disorders gait alterations difficulties for communication and understanding wheezing or pulmonary disease two weeks before to start the program hemodynamic changes (heart rate > 130bpm, systolic blood pressure > 130bpm, diastolic blood pressure > 80bpm) heart and/or lung transplantation. Healthy children age between 4 to 6 years old antecedents of pulmonary or cardiac chronic disease congenital malformations | 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): 0.5-19.0, Influenza Healthy infants and adolescents aged 6 month to 19 years 2. study Subject was born at full term pregnancy(37 weeks) 3. study Subject who understand the details of this clinical trial, decide voluntarily to participate the trial, and signed the Informed Consent Form (less than 7 years of age, written informed consent by study subject's legal guardians) Those with a history of allergic reaction to eggs or chicken, the vaccine components 2. Those who had been ad ministered the influenza vaccine 6 months prior to the study drug vaccination 3. Those with immunologic impairment including immune deficiency disorders or family history about it. 4. Those with a history of Guillain-Barre syndrome 5. Those with a history of Down's syndrome or cytogenetic disorders 6. Those who would be ineligible to participate the study as follows: serious chronic disease (cardiovascular system disease; excluding controlled hypertension and respiratory system disease; including respiratory failure, metabolic disease, renal dysfunction, hemoglobinopathy, etc) 7. Hemophilia patients at risk of serious bleeding with intramuscular injection or those receiving anticoagulant therapy 8. Those who have active infection or who have fever higher than 38.0℃ within 72 hours prior to the dosing of study drug 9. Those who had been vaccinated with another vaccine within 28 days prior to the dosing of study drug or had a scheduled vaccination during the clinical trial period 10. Those who had received an immunosuppressant, immunity-modifying drug within 3 months prior to the dosing of study drug (1) Azathioprine, Cyclosporin, Interferon, G-CSF, Tacrolimus, Everolimus, Sirolimus, etc., (2) Those receiving high dose of corticosteroid(15mg/day of prednisolone is acceptable, but study subject used consistently 2mg/kg more than 14days is considered a high dose, so excluded in this clinical trial. However, inhalated, intra nasal and topical administration is acceptable regardless of dose. 11. Those who had received immunoglobulin or a blood-derived product within 3 months prior to the dosing of study drug or is scheduled to receive those products during the study period 12. Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4 hours prior to the dosing of study drug 13. study Subject who had participated in other clinical trial within 28 days prior to the study vaccination 14. Those whose clinically significant medical or psychiatric condition at the discretion of the investigator that would be ineligible to participate 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): 18.0-999.0, Pregnancy Pregnant women at ≥37 weeks gestation by reliable dating as determined by the American College of Obstetricians and Gynecologists (i.e. gestational age supported by one of the following: ultrasound prior to 20 weeks of gestation, fetal heart tones auscultated by Doppler for 30+ weeks, or documented serum or urine pregnancy test 36+ weeks ago) 2. Scheduled induction of labor with indication and timing supported by the Family Birth Center induction of labor guideline entitled "Induction of labor: Indications and Timing" 3. Singleton gestation 4. Cephalic presentation 5. Amniotic fluid index greater than or equal to 5 centimeters 6. Formal prenatal ultrasound documenting the absence of placenta previa 7. Bishop score <6 and cervical dilation <3cm 8. The woman is able to give appropriate consent and has undergone an informed consent process. 9. Maternal age ≥ 18 years old at the time of consent New diagnosis requiring immediate hospitalization for monitoring (such as new onset hypertensive disease of pregnancy) 2. Vaginal bleeding 3. Active labor 4. Premature rupture of membranes as determined by positive ferning and as supported by pooling of fluid in the vaginal vault. 5. Uterine tachysystole (>5 contractions in 10 minutes) 6. Nonreassuring fetal heart tracing before or after Foley placement 7. Chorioamnionitis or maternal fever 8. Intrauterine fetal demise 9. Contraindication to vaginal delivery, relative or absolute (i.e. transfundal uterine surgery) 10. Abnormal placentation including a low lying placenta 11. Prior cesarean delivery 12. Intrauterine growth restriction (growth <10th percentile by formal ultrasound) 13. Known fetal anomaly 14. Human immunodeficiency virus, Hepatitis C, or active herpes infection 15. Maternal cardiopulmonary disease requiring cardiac monitoring during labor 16. Pregestational diabetes 17. Rh isoimmunization 18. Non-English speaking 19. Distance from the hospital over 60 minutes by car, unreliable communication via telephone, or unreliable transportation | 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, Seasonal Influenza B In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment Positive for B influenza by HAI Has had an influenza vaccine in the past 2 years Current history of chronic alcohol use and/or illicit and/or recreational drug use History of any confirmed or suspected immunodeficient or immunosuppressive condition Positive serology for HIV, HCV, or HBV Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine Use of proton pump inhibitors(Nexium, Prilosec) Stool sample with occult blood at baseline exam Pregnancy | 1 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 65.0-999.0, Influenza Aged ≥ 65 years on the day of Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 Vaccination against influenza in the past 6 months 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 or bleeding disorder, contraindicating IM vaccination based on investigator's judgment Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily Substance abuse that, in the opinion of the investigator, might interfere with the trial conduct or completion Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion | 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): 5.0-999.0, Allergic Rhinitis Patients aged 5 years or older having allergies within the scope of specifications stated in the patient information leaflet Contraindications according to the patient information leaflet | 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): 50.0-75.0, Immunosenescence Ability and willingness to provide written informed consent Ability and willingness to undergo 2 cycles of a 5-day dietary regimen Ability and willingness to provide blood samples via venipuncture Seeking to get a seasonal influenza vaccine Concomitant medications Received flu (influenza) shot for the flu season Receiving immunosuppressive therapy (i.e., oral prednisone in doses > 10 mg daily) On immunosuppressive drugs for cancer or rheumatologic therapy Receiving insulin or octreotide On hypertension medication. The subject must obtain the treating doctor's approval prior to beginning the study. Safety-based exclusions Hemoglobin < 9.0 g/dL White blood cell count < 3,500/mm^3 Neutrophil count < 2,000/mm^3 Platelet count < 125,000/mm^3 | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Influenza Subject is ≥ 18 years of age on the day of Informed consent form has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures History of serious adverse reaction to any influenza vaccine Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study, unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Prior vaccination with any 2015-2016 formulation of influenza vaccine Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent, Fluzone Intradermal Quadrivalent, or Fluzone High-Dose vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information) Receipt of immune globulins, blood, or blood-derived products in the past 3 months Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine | 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): 25.0-65.0, Healthy Males to 65 years old Allergies to oats Parallel participation in another research project Having flu vaccination or antibiotics within 3 months of trial start Taking food supplements within 3 months of trial start Past or existing medical history of vascular disease, diabetes, hepatic, renal, gastrointestinal, haematological, neurological, thyroidal disease or cancer | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Mucociliary Clearance Defect Physical Disability In mechanical ventilation for a period of 24-72 h End-expiratory pressure (PEEP) lower 10 cm of water Lower noradrenaline doses of 0.5mg / kg / minute for an average greater than or equal blood outstrips 60 mmHg Pneumothorax and hemothorax undrained Subcutaneous emphysema Osteoporosis Acute respiratory distress syndrome (ARDS) Fractures of ribs Obese ( BMI greater than 35) Mechanical ventilator with higher peak pressures 40 cm of water | 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, Allergic Rhinitis Patients aged 18 years or older having allergies within the scope of specifications stated in the patient information leaflet Contraindications according to the patient information leaflet | 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, Hepatitis C HIV Male and females ≥18 years Documented HIV infection Evidence of infection with hepatitis C virus (all genotypes): Positive anti-HCV antibody and HCV RNA Absence of advanced liver disease or clinical signs of extra-hepatic disease F0-F2 (< 9,5 kPa) established by transient elastography, and No clinical signs of extra-hepatic disease Not on HCV antiviral treatment Currently on/or history of hepatitis C treatment Patients with initial fibrosis stage ≥ F3 (≥ 9,5 kPA on transient elastography) Patients not able/willing to adhere to the consultation, laboratory and liver stiffness measurement testing schedule as proposed in 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, Low Back Pain subjects should be independent to walk subjects should have unspecific low back pain during at least the last two months subjects should have had at least two recidives of low back pain within the last year subjects with concomitant pathologies that impede the performance of exercises pregnants subjects with oncologic pathologies subjects with cognitive alterations that impede the understanding of the tests | 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): 3.0-7.0, Acute Upper Respiratory Tract Infections (Common Cold) Parents / legal guardians signed written informed consent to participate in the study. 2. Healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment. 3. Children attending day care center or school. 4. No consumption of commercial products containing probiotics during the whole study period. 5. Children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day). 6. Ability of the parents / legal guardians (in the Investigator's opinion) to comprehend the full nature and purpose of the study. 7. Parents' / legal guardians' consent to the study and willing to comply with all its procedures Children presenting one or more of the following will not be eligible to enter the study. 1. Flu vaccine administration within the last 3 months prior to enrollment. 2. Use of antibiotics within the last 30 days prior to enrollment. 3. Acute infection or fever at enrollment. 4. Any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study. 5. Any kind of immunodeficiency or allergy (including known food allergy). 6. Subjects with known hypersensitivity or allergy to any component of the study products. 7. Significant illness within the 2 weeks prior to the enrollment or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study. 8. Currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of 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): 18.0-45.0, Healthy Signed informed consent 2. Ages between 18-45 years, inclusive 3. Non-tobacco/nicotine use (at least 3 months) 4. BMI of 17-35 kg/m2 inclusive 5. Able to comply with all study procedures and follow-up 6. Healthy on the basis of screening medical exam, blood chemistries, hematology, and serum pregnancy tests for females (at screening ) 7. Non-pregnant or breast-feeding History of current use of narcotics, or recreational drug use. 2. Use of > 7 alcoholic beverages in 1 week 3. Any acute illness such as asthma, cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal (including eating disorder), endocrine/metabolic, neurologic, dermatologic, or psychiatric disease. 4. Treatment with another investigational product in the past 30 days 5. Immunocompromised status including HIV by history 6. Use of any other intra-oral product (especially antiseptic). 7. Intended use of mouthwash during study duration 8. Laboratory (screening) of creatinine > 1.5 X ULN, hemoglobin < 10.5 g/dL, platelet count ≤ 99,000/mm3, absolute neutrophil count ≤1200/ mm3, serum glucose ≥ 150 mg/dl (Subject can enroll prior to receiving lab results. Subject will be contacted if lab results are an and discontinue from study) 9. Use of any systemic antibiotic or antifungal within 30 days of screening 10. Prior or current history of seasonal allergies, chronic sinusitis or rhinitis 11. Allergy to any component of Halo 12. Oral lesions 13. Dentures 14. Dental Treatment currently in progress (implants, root canals, complex restorative procedures) | 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, Degenerative Spondylolisthesis Chronic Low Back Pain Degenerative spondylolisthesis at L4-L5 and chronic LBP with or without radicular pain Attending the Spinal Rehabilitation Service of the National Institute for Rehabilitation (Mexico City) Without previous treatment Agree to participate through informed consent History of lumbar surgery Rheumatic diseases: Rheumatoid Arthritis, Lupus Erythematosus Systemic, Fibromyalgia, etc Cauda equine symptoms Ischemic heart disease Diabetic polyneuropathy Illiterate | 0 |
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