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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-85.0, 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
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Mastectomy Related Lymphedema Lymphedema of Upper Limb Lymphedema of Lower Extremity men and women who are 18 years of age or older who have been diagnosed with UL or LL SLC a minimum of 3 months prior to data collection who are in the management phase of SLC treatment at the time of enrolment are English speaking are able to consent being in the active phase of LE treatment. Because this type of acute care involves intensive and time-consuming treatment, which would make participation in the proposed research extremely challenging, we will enroll only men and women who are in the management phase of treatment non-English speaking. Non-English speaking participants will be excluded given time and resource constraints. In our recent qualitative study of SLC, no non-English speaking potential participants from Ottawa expressed an interest in the study. Future research (to expand the pilot intervention, if successful) will be bilingual As noted previously individuals scoring in the top ~30% (n=16) in terms of hope according to the MIQ, will be excluded from the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, IgA Nephropathy Willingness to sign an informed consent Age:18~45 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for immunoglobulin A nephropathy (IgAN), excluded secondary IgAN. Renal histological should be defined by Lee's glomerular grading system Any one of three Tonsilar conditions defined by Otorhinolaryngologist : 1,recurrent acute tonsillitis accompanied with gross hematuria or urinary findings abnormality；2,recurrent acute tonsillitis without gross hematuria，but tonsil provocation test was positive；3, No history of acute tonsillitis,body examination found hypertrophy or atrophy tonsils ,crypt pus of tonsils ,or scars on the tonsil surface ,and positive tonsil provocation test Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 Inability or unwillingness to sign the informed consent Inability or unwillingness to meet the scheme demands raised by the investigators Rapidly progressive nephritic syndrome and acute renal failure, 24-hour urine protein≥3.5g,including rapidly progressive IgAN (IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis est GFR < 30 mL/min/1.73m2 Malignant hypertension that is difficult to be controlled by oral drugs Cirrhosis, chronic active liver disease History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease.) Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Delivery 2nd Stage of Labor Patients will be women who are nulliparas or multiparas (≥ 1 previous child) who attended the complete training session on the types of pushing assessed in this trial; during prenatal childbirth preparation and parenthood classes (regardless of the type of prenatal preparation) for whom a vaginal delivery was planned at the end of pregnancy admitted to the maternity ward between 37 and 42 weeks of gestation (≥ 37 weeks and ≤ 42 weeks) in spontaneous or induced labor with cervical dilatation ≥ 7 cm with a singleton pregnancy in cephalic presentation who provided informed consent in writing and speaks and writes French Women who are minors adults but incapable of providing consent for the study with a disorder contraindicating prolonged pushing with a uterine scar (previous cesarean or other surgery) with a contraindication to vaginal delivery with a maternal disease that could justify in the short-term termination of the pregnancy (HELLP syndrome, preeclampsia [hypertension with albuminuria > 0.3 g by 24 hours], eclampsia, abruptio placentae, etc.) with a major genital hemorrhage with a major fetal malformation and/or hydramnios or oligohydramnios, and/or FGR (<5°percentile), diagnosed in utero with a fetal heart rate anomaly before randomization
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, 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
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, 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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Measurement of Fetal Blood Lactate women who have a fetal blood sample or umbilical cord blood sampling as part of their care during childbirth women in Prison
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Influenza In good health with no history of major medical conditions A total body weight ≥ 50 kg and a BMI of >18 Acceptable forms of effective contraception An informed consent document signed and dated by the subject and Investigator Sero-suitable for Challenge Virus Subjects who have a significant history of any tobacco use at any time (≥ total 10 pack year history, e.g. one pack a day for 10 years) Subjects who have been pregnant within six months prior to the study, or who have a positive pregnancy test at any point in the study Any history or evidence of any clinically significant medical conditions (cardiovascular, gastrointestinal, endocrinological, haematological, hepatic, immunological, metabolic, urological, neurological, psychotic, renal, and/or other major disease or malignancy) History or evidence of autoimmune disease or known immunodeficiency of any cause Subjects with any history of asthma, COPD, pulmonary hypertension, reactive airway disease, or chronic lung condition of any aetiology Positive human immunodeficiency virus (HIV), Hepatitis A (HAV), B (HBV), or C (HCV) test Any significant abnormality altering the anatomy of the nose or nasopharynx Any clinically significant history of epistaxis (nose bleeds) Any nasal or sinus surgery within six months of inoculation Recurrent history of clinically significant autonomic dysfunction
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Pain, Menstrual American Society of Anesthesiology Classification (ASA) I-II 45 years Regular menstrual cycle Irregular menstrual cycles Patients receiving hormones or drugs affecting the ovulatory cycle Amenorrhea Pregnancy Climacteric patients
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, 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
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, 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
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Influenza The disease in flu season of flu, in line with the western medicine clinical diagnostic for influenza; 2. All influenza patients with TCM syndrome differentiation for the table is cold in the exterior and heat in the interior; 3. The course of the disease within 48 hours, the axillary temperature is 38.0 degree or higher; 4. Aged between 18 to 65 years; 5. Voluntary and signed informed consent The first time to see a doctor Have used traditional Chinese medicine, or antiviral drugs; 2. Routine blood WBC is greater than the upper limit of normal; 3. Chest X-ray examination with inflammatory exudation images; 4. With cardiovascular, liver, kidney and hematopoietic system such as severe primary disease, immunodeficiency disease, cancer, mental illness, without self-knowledge, liver and kidney function significantly abnormal liver meritorious service is more than 1.5 times higher than normal; 5. Pregnancy, nursing mothers, and allergic constitution; 6. Participated in clinical subjects for nearly three months
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, Determine Minimally to Moderately Infective Dose (MMID) of Influenza A H3N2 Greater than or equal to 18 and less than or equal to 50 years of age. 2. Agrees to not use tobacco products during participation in this study. 3. Willingness to remain in isolation for the duration of viral shedding (at a minimum 9 days) and to comply with all study requirements. 4. A female participant is eligible for this study if she is not pregnant or breastfeeding and meets 1 of the following Of nonchildbearing potential (i.e., women who have had a hysterectomy or tubal ligation or are postmenopausal, as defined by no menses in more than or equal to 1 year) Of childbearing potential but agrees to practice effective contraception or abstinence for 4 weeks prior to and 8 weeks after administration of the influenza challenge virus. Acceptable methods of contraception 1 or more of the following: 1) male partner who is sterile prior to the female participant s entry into the study and is the sole sexual partner for the female participant; 2) implants of levonorgestrel; 3) injectable progestogen; 4) an intrauterine device with a documented failure rate of <1%; 5) oral contraceptives; and 6) double barrier methods including diaphragm or condom with a spermicide. 5. Willing to have samples stored for future research. 6. Pre-challenge serum hemaglutination-inhibition titer against the challenge strain of less than 1:40. 7. HIV uninfected Presence of self-reported or medically documented significant medical condition including but not limited to: 1. Chronic pulmonary disease (e.g., asthma, emphysema). 2. Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects). 3. Chronic medical conditions requiring close medical follow-up or hospitalization during the past 5 years (e.g., insulin-dependent diabetes mellitus, renal dysfunction, hemoglobinopathies). 4. Immunosuppression or ongoing malignancy. 5. Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures). 6. Post infectious or post vaccine neurological sequelae. 2. Have close or household (i.e., share the same apartment or house) high-risk contacts including but not limited to: 1. Persons more than or equal to 65 years of age. 2. Children less than or equal to 5 years of age. 3. Residents of nursing homes. 4. Persons of any age with significant chronic medical conditions such as Chronic pulmonary disease (e.g., asthma) Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects) Contacts who required medical follow-up or hospitalization during the past 5 years because of chronic medical conditions (e.g., insulindependent diabetes mellitus, renal dysfunction, hemoglobinopathies) Immunosuppression or cancer Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures) Persons who are receiving long-term aspirin therapy Women who are pregnant, trying to become pregnant, or breastfeeding. 3. Individual with body mass index (BMI) less than or equal to 18.5 and more than 40. 4. Smokes more than 4 cigarettes or other tobacco products on weekly basis. 5. Complete blood count (CBC) with differential outside of the NIH DLM normal reference range and deemed clinically significant by the PI. 6. Chemistries in the acute care, mineral, and/or hepatic panels, and/or any of the following: lactate dehydrogenase, uric acid, creatine kinase, and total protein outside of the NIH DLM normal reference range and deemed clinically significant by the PI. 7. Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI. 8. Clinically significant abnormality as deemed by the PI on electrocardiogram (EKG) 9. Clinically significant abnormality as deemed by the PI on echocardiographic testing (ECHO). 10. Clinically significant abnormality as deemed by the PI on the Pulmonary Function Test (PFT). 11. Recent acute illness within 1 week of admission to the isolation facility. 12. Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals). 13. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides). 14. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment. 15. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment. 16. Receipt of any unlicensed vaccine within 6 months prior to enrollment. 17. Self-reported or known history of current alcoholism or drug abuse, or positive urine/serum test for drugs of abuse (i.e., amphetamines, cocaine, benzodiazepines, opiates, or metabolites, but not THC or metabolites). 18. Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation 19. Known close contact with anyone known to have influenza in the past 7 days. 20. Any condition that, in the judgment of the PI, is a contraindication to protocol participation or impairs the volunteer s ability to give informed consent
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, 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
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-75.0, Surgical Wounds Signed and dated written informed consent form 2. Female patients, aged between 18 and 75 years old 3. Good general health, stable weight, free of systemic diseases such as diabetes, arthritis, HIV infection or genetic disorder that could influence the outcome of the treatment 4. Fitzpatrick skin type I to IV 5. Patients scheduled to go through bilateral breast reduction and expected to have newly formed post-surgery breast incisions of comparable length, located on comparable skin area 6. Patients able to understand, willing and able to comply with all study requirements 7. Patients must either be incapable of reproduction, or taking acceptable measures to prevent pregnancy and have a negative pregnancy test prior to participation in the Study 8. Females of childbearing potential must not be lactating at Study Screening and agree to use adequate contraceptive method during the Study Inability to understand the Study and its requirements or to give informed consent 2. Patient has participated in any other clinical study within 3 months prior to Study Screening and throughout the Study duration 3. Systemic antibiotic therapy or anti-inflammatory drugs or any other medication(s) that might interfere with healing within the last three months prior to Study Screening and throughout the Study duration 4. Current use of anticoagulants such as (but not limited to) warfarin, clopidogrel, enoxaparin or high doses of aspirin (> 162 mg daily) 5. Patient with current alcohol use or actively consuming drugs (addiction) as it may interfere with patient's ability to comply with Study procedures 6. Female patient pregnant, nursing or planning to become pregnant within the next 18 months 7. Patient is a current smoker or has been smoking or using nicotine product(s) in the last three months 8. Patient with known photosensitivity, taking drug(s) to treat photosensitivity, with concurrent disease (such as porphyria) or drug(s) (such as methotrexate or chloroquine) known to induce severe photosensitivity of the skin 9. Patients who are immunocompromised or taking immunosuppressive therapy 10. Any concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the Study investigational device 11. Patient has ongoing malignant disease of any type, active systemic, local skin infection or disease, autoimmune disease or any significant chronic disease which, in the opinion of the investigator, might interfere with the evaluation of the Study objectives or would result in non-compliance with the Study protocol 12. Patients with known hypersensitivity to pain medications 13. Patients with severe elastosis 14. Patients with severe or cystic acne on the area(s) to be treated 15. Presence of a metal stent or implant in the area(s) to be treated 16. Patients with derma resurfacing procedures or non-invasive skin-tightening procedures including medium/deep chemical peeling, microdermabrasion, laser therapy or prescription level glycolic acid treatment to the treatment area(s) within three months prior to Study Screening or during the Study 17. Patients anticipating the need for surgery or overnight hospitalization during the course of the Study 18. Patients with history of keloids or hypertrophic scars 19. Patients anticipating sun tanning bed or excessive sun exposure during the Study period 20. Patients with significant breast asymmetry that may result in asymmetrical operative incisions being made on the left and right breasts 21. Patients with breast asymmetry that may result in different post-operative tensions on the wounds of the left and right breasts 22. Patients having had surgery in the area to be incised within one year of Study Screening 23. Patients with tattoos in the areas of incisions 24. Patients with incisions that are actively bleeding 25. Patients with history of irradiated breast(s) in the area(s) to be treated
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, 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
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Pregnancy Repeat Cesarean Section Vaginal Births After Cesarean Women with exactly one prior Cesarean Delivery. 2. Current singleton pregnancy. 3. Gestational age, 12-24 weeks. 4. English or Spanish speaker. 5. Must be receiving prenatal care at one of the participating centers Contraindications to vaginal delivery (e.g., placenta previa, prior classical cesarean, previous uterine rupture). 2. Prior VBAC
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 13.0-55.0, Contraception Patient has chosen to use the implant as a method of contraception Patients will be assessed for medical for the contraceptive implant have no contraindications to either the implant, lidocaine or the ethyl chloride spray. However, if they have a known sensitivity to either the spray or the lidocaine ejection, they will be offered the other Age between 13 and 55 Has capacity to consent Has read the information sheet and consents to the study This will be offered for insertions of implant only i.e. not implant removals Has a contraindication to have a contraceptive implant Doesn't wish to have a implant Allergy to either the implant, the lidocaine, the ethyl chloride or any of the incipient ingredients. Although patients will be given the option, if they have an allergy/contraindication to one of the products, they will be offered the other Is under 13 or over 55
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Hip Surgery Corrective Knee Injuries enrolment phase 1. Age ≥ 18 years 2. Have an expected total length of stay of 4 postoperative days or more 3. Plan for elective primary arthroplasty of the hip or knee 4. Plan for incision size > 18 cm 5. Give their written informed consent to participate randomization phase 1. Undergoing elective primary arthroplasty of the hip or knee enrolment phase 1. Known allergy or hypersensitivity to any of the components of the dressings 2. Multitrauma 3. Undergoing arthroplasty due to tumour 4. Wound at the surgical site prior to surgery 5. Neurological deficit of operated side ,hemiplegia, etc. 6. Documented skin disease at time of enrolment, as judged by the investigator 7. Previously enrolled in the present investigation 8. Included in another ongoing investigation at present which can interfere with the result of the dressing, judged by the investigator 9. Involvement in the planning and conduct of the clinical investigation, applies to all Molnlycke Health Care staff, investigational site staff and third party vendor randomization phase 1. Dressing size does not fit the incision area, over 18 cm 2. Complications that would increase wound risks if investigation dressing is applied 3. Postoperative drain
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Smoke Surgical patients who receive head-neck or breast surgery or surgical patients who receive abdominal laparoscopic surgery Emergency cases
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Depression Sedentary, i.e., have not participated regularly in moderate-to-vigorous physical activity (MVPA) for 90 minutes per week or more for the past 12 weeks. 2. Medically cleared for MVPA, documented by a note from their primary care provider. 3. No significant medical condition or physical disability that would interfere with physical activity or study participation. The investigators will individuals with significant cardiovascular disease, hematologic disorders, and autoimmune disorders. The investigators will also individuals who are planning a surgery in the next 9 months and those with dementia. 4. Elevated depression symptoms. To meet for elevated symptoms, participants must have a QIDS score of 10 or greater (i.e., at least moderate depression levels), and must have a score of "1" or greater on at least one of the two core DSM-V depressive symptoms, i.e., sad mood or anhedonia. - 5. No current bulimia or anorexia (past 3 months); no history of bipolar disorder, schizophrenia, or a chronic psychotic condition (assessed using the SCID). 6. No hazardous drug or alcohol use in the past 6 months, as assessed by: a. no substance abuse treatment in the past 6 months; and b. does not meet for a substance use disorder in the past 6 months. 7. Depression is not very severe, i.e., QIDS score is < 20. 8. No suicidality requiring immediate treatment. 9. Not pregnant or planning on becoming pregnant in the next year. 10. Understands English sufficiently well to consent and complete study assessments. 11. Aged 18-65. 12. Able to make one of the 2 available exercise class times. 13. Able to walk 1 mile
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Normal Physiology Healthy Healthy women and men will be eligible for study participation if they meet the following A participant will have passed his/her 18th birthday and will not have attained the age of 50 at the time of enrollment Willing to allow storage of their biological samples Able to comply with study procedures and swallow capsules An individual who meets any of the following will be excluded from study participation Body Mass Index (BMI) greater than or equal to 35 or less than or equal to 18 kg/M(2) Vital signs outside of acceptable range at Screening Visit, i.e., blood pressure >160/100, oral temperature >100 degrees F, pulse >100 Use of any of the following drugs or devices within the last 6 months systemic antibiotics, antifungals, antivirals, or antiparasitics (intravenous, intramuscular, or oral) oral, intravenous, intramuscular, nasal, or inhaled corticosteroids cytokines methotrexate or immunosuppressive cytotoxic agents large doses of commercial probiotics consumed (greater than or equal to 10(8) cfu or organisms per day), including tablets, capsules, lozenges, chewing gum, or powders in which probiotic is a primary component. Ordinary dietary components such as fermented beverages/milks, yogurts, and foods do not apply anabolic steroids
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Cancer of the Lung Lung Cancer Lung Neoplasms Adenocarcinoma of the Lung Non Small Cell Carcinoma of the Lung Small Cell Carcinoma of the Lung years of age or older, not previously diagnosed with cancer (except for basal cell carcinomas of the skin or a diagnosis of cancer within a month of surgery and for which the surgical procedure is being performed) Prior history of cancer
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Community-acquired Pneumonia, Influenza, COVID-19 REMAP-CAP 1. Adult patient admitted to an ICU for severe CAP within 48 hours of hospital admission with: 1. symptoms or signs or both that are consistent with lower respiratory tract infection AND 2. Radiological evidence of new onset consolidation (in patients with pre-existing radiological changes, evidence of new infiltrate) 2. Up to 48 hours after ICU admission, receiving organ support with one or more of: 1. Non-invasive or Invasive ventilatory support; 2. Receiving infusion of vasopressor or inotropes or both Healthcare-associated pneumonia: 1. Prior to this illness, is known to have been an inpatient in any healthcare facility within the last 30 days 2. Resident of a nursing home or long term care facility 2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 3. Previous participation in this REMAP within the last 90 days REMAP-COVID 1. Adult patients (≥ 18 years) admitted to hospital with acute illness due to suspected or proven pandemic infection. REMAP-COVID Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment 2. Patient is expected to be discharged from hospital today or tomorrow 3. More than 14 days have elapsed while admitted to hospital with symptoms of an acute illness due to suspected or proven pandemic infection. 4. Previous participation in this REMAP within the last 90 days Each domain may have additional criteria. Refer to the study website for more information (www.remapcap.org)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 9.0-45.0, Human Papillomavirus Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination Provide legal identification for for the sake of recruitment Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition) Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months History of cervical cancer Previous administration of any HPV vaccine History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) History of allergic to vaccine, or to any ingredient of vaccine History of epilepsy, seizures or convulsions, or family history of mental illness Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder Acute disease or chronic disease acute exacerbation 7 days prior to vaccination
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Urothelial Carcinoma Urothelial Cancer Lung Neoplasms Small Cell Lung Cancer Prostate Cancer Phase I Patients must have advanced solid tumor that is resistant or refractory to standard therapy A minimum of 2 weeks will be required from any prior therapy, including chemotherapy, immunotherapy and/or radiation. In addition, recovery to Grade less than or equal to 1 from all reversible toxicities related to prior therapy is required at study entry Patients do not need to have measurable disease to enroll on phase I Age greater than or equal 18 years ECOG performance status less than or equal to 2 Patients with treated brain metastases (surgery, whole or stereotactic brain radiation) are allowed provided the lesions have been stable for at least 2 weeks and the patient is off steroids or is on a stable dose of steroids. Patients with brain metastases should not require use of enzyme-inducing antiepileptic drugs (e.g., carbamazepine, phenytoin, or phenobarbital) within 14 days before first dose and during study. Use of newer antiepileptics that do not produce enzyme induction drug-drug interactions (DDIs) is allowed Patients must have normal organ and marrow function as defined below leukocytes greater than or equal to 3,000/mcL absolute neutrophil count >1,500/mcL without growth factor support
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 21.0-999.0, Fertility Females, age ≥ 21 years Premenopausal (defined as a woman that has had at least one menstrual cycle in the last 365 days) A minimum weight of 110 lbs The subject is not anemic (Hemoglobin ≥ 12.5 g/dL) Willing to provide a daily blood draw for one ovulatory cycle or a maximum of 33 days Able to understand and willing to provide informed consent Males Females, age <21 years Weighing < 110 lbs Anemic (Hemoglobin < 12.5 g/dL) History of bilateral oophorectomy Females taking any form of hormonal birth control including Oral contraceptive pill (combined or progestin-only) within five days enrollment Contraceptive patch (such as Ortho Evra®) within seven days of enrollment Vaginal contraceptive ring (such as NuvaRing™) within 21 days of enrollment Contraceptive injection (such as Depo-Provera®) within 90 days of enrollment
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Desmoplastic Melanoma A: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is deemed resectable; the decision to perform surgery on patients must be based on good clinical judgment; eligible patients for surgical resection must have disease that, in the judgment of the surgeon, is deemed completely resectable resulting in free surgical margins; patients must have residual disease after initial biopsy which can be measurable or non-measurable disease per Response Evaluation in Solid Tumors (RECIST) 1.1; residual disease can either be confirmed with fine-needle aspiration (FNA) or if measurable disease is present, no FNA needs to be obtained OR B: Patients must have histologically or cytologically confirmed primary desmoplastic melanoma that is unresectable; patients in Cohort B must have measurable disease per 1.1 Contrast-enhanced computed tomography (CT) scans of the chest, abdomen and pelvis are required; a whole body positron emission tomography (PET)/CT scan with diagnostic quality images and intravenous iodinated contrast may be used in lieu of a contrast enhanced CT of the chest, abdomen and pelvis; imaging of the head and neck is required only if the patient has a head/neck primary; contrast may be omitted if the treating investigator believes that exposure to contrast poses an excessive risk to the patient; if skin lesions are being followed as measurable disease, photograph with a ruler included and physician measurements, must be kept in the patient's chart as source documentation; all measurable lesions must be assessed within 28 days prior to registration; tests to assess non-measurable disease must be performed within 42 days prior to registration; all disease must be assessed and documented on the baseline tumor assessment form (RECIST 1.1) Patients must not have known brain metastases unless brain metastases have been treated and patient is asymptomatic with no residual neurological dysfunction and has not received enzyme-reducing anti-epileptic drugs or corticosteroids for at least 14 days prior to registration Patients must not have received prior systemic treatment for this melanoma Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, anti-cancer surgery or other anti-cancer therapy while on this protocol Patients must not have received radiation therapy, non-cytotoxic agents or investigational agents or systemic corticosteroids within 14 days prior to registration Patients may have received prior surgery; all adverse events associated with prior surgery must have resolved to =< grade 1 (per Common Terminology for Adverse Events [CTCAE] 4.0) prior to registration Absolute neutrophil count (ANC) >= 1,500/mcl (obtained within 28 days prior to registration) Platelets >= 50,000/mcl (obtained within 28 days prior to registration)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Poly Cystic Ovary Syndrome Premenopausal women between 18-45 years of age and BMI less than 42 Diagnosed with PCOS Adequate hepatic, renal and hematological functions Patients willing to give informed consent in writing Males Post menopausal women Women with hysterectomy Patients with congenital adrenal hyperplasia Patients suffering from Cushing's syndrome Patients diagnosed with androgen secreting tumors Patients with thyroid dysfunction (T3, T4 level is higher than that in normal women of reproductive age) Patients with Hypo-gonadotropic and Hypo-gonadism (central origin of ovarian dysfunction) Pregnancy or desire for pregnancy or lactating mothers
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Aphthous Stomatitis year-old or more Recurrent idiopathic aphtous stomatitis with at least one new lesion per month during the past 6 months Symptomatic aphtosis associated with Crohn or Behcet disease Concomitant use of probiotic for any other reason Systemic use of colchicine or steroids or immunosuppressive drugs during the past 3 months
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-28.0, Hormones Female 2. Between 18 and 28 years of age (inclusive) 3. Reported menarche between the ages of 11 and 14 years 4. Gynecological age of less than or equal to 14 years 5. A history of self-reported regular menstrual cycles when not on contraceptive medication of between 25 and 35 days (inclusive) at prescreen and knowledge of date of onset of menses before the screening visit 6. A BMI of 18.5 to 27 kg (Summation)m(2) and a weight >= 93 lbs. 7. Agrees to use barrier contraception method for the duration of the study 8. Agrees to abstain from alcohol consumption during both 5-day diet/exercise study interventions 9. Agrees to abstain from donating blood during the study and within 30 days of completing the study 10. Is willing and able to fulfill the requirements of the protocol and to provide informed consent 11. Able to speak and read English 12. Lives within 50 miles of the Clinical Research Unit Currently lactating or pregnant or planning on becoming pregnant for the duration of the study 2. Has ever given birth 3. History in the past 3 months of dieting or weight loss amounting to greater than 2 kg (4.4 lbs) 4. > 4 hours per week of aerobic exercise for the past 3 months 5. Has initiated training for an athletic sport or event in the past 3 months that, in the opinion of the investigator, may interfere with the results of the study 6. Currently using hormone-based contraception, including those administered orally, vaginally, via injection, sub-dermally, or transdermally 7. Current use of medications or supplements that may interfere with the results of the study, including: i.Steroids ii.Hormone-based contraception iii.Sleeping pills iv.Homeopathic substances (e.g. Chinese herbs, protein or other powders, and other-the-counter extracts) v.Stimulants (e.g. Ritalin) vi.Antidepressants or anti-epileptic medications or centrally acting anti-hypertensive medications 8. Current use of recreational drugs (alcohol intake will be monitored and excluded during the two intervention periods) 9. Unable to consume food containing dairy or nuts 10. Has currently or has a history of any of the following: autoimmune, heart, liver, renal disease, diabetes, or another health condition deemed by the PI to be a contraindication to study participation. History of thyroid disorder is permissible if the patient is biochemically euthyroid on replacement. Additional to be Met Prior to Start of Intervention(s): 1 Habitual energy intake between 35-55 kcal/kg LBM*day 2 VO2max less than or equal to 40 ml/kg/min with the option to increase this at the discretion of the PI, depending on the current and past exercise level of the participant 3 Hemoglobin, prolactin and TSH within normal female range for testing laboratory. 4 Ovulation confirmed in the cycle before each study intervention by self-reported positive urine test, ultrasound and/or progesterone blood-levels
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Tonsillitis Patient admitted at hospital for tonsillitis requiring, for the emergency physician, a microbiological examination with a "POC tonsillitis kit." Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Pregnant woman, parturient or nursing Adult patient under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 3.0-17.0, Hematopoietic Cell Transplantation Recipient Malignant Neoplasm Influenza FOR YEAR 2: A. A target of at least 200 pediatric patients who received an allogeneic HSCT 1 Allogeneic HSCT recipients who are 3-35 months post-transplant 17 years of age, inclusive Available for duration of study If patients are on immunosuppressive therapy for treatment of GVHD, then only those on stable doses for at least 4 weeks (or on tapering doses) will be eligible Parent/legal guardian willing and capable of signing written informed consent Parent/legal guardian expected to be available for entire study Parent/legal guardian can be reached by telephone or email Subjects must have a platelet count of ≥30,000 to receive the immunizations. Patients requiring platelet transfusions are eligible to enroll and must have a platelet count ≥30,000 within 72 hours prior to their immunization, or platelet count ≥75,000 without transfusion documented within 30 days for subjects <12 months post-transplant and within 90 days for subjects 12-35 months post-transplant Recipients of CD34 selected grafts or other manipulated grafts (with any form of ex vivo T cell depletion) will be eligible to enroll if they have a CD3 count >100. (Please note: post-transplant cytoxan for haploidentical transplants is allowable). 2 History of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein History of Guillain-Barre syndrome Evidence of hematologic malignancy or disease relapse post-transplant (stable mixed chimerisms is permitted) History of receiving current year seasonal influenza vaccine influenza vaccine Pregnant female History of proven influenza disease after September 1, 2017 Non-allogeneic (e.g. autologous) or syngeneic hematopoietic SCT recipients History of known active infection with HIV, Hepatitis B or Hepatitis C History of known severe latex hypersensitivity Subjects who have received stem cell boost or delayed donor lymphocyte infusion within 90 days of enrollment, including day of enrollment
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-80.0, Thyroid Diseases Age 20-80 years old Thyroid diseases, including nodular goiter, hyperthyroidism, hypothyroidism and thyroid cancer (before or after operation), consecutive follow-up in outpatient department, and we expected to enroll 800 patients in one year, and follow-up with observation for 5 years N/A
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Tonsillectomy Adults (male or female) ≥22 in United States and ≥18 years of age in Europe years of age 2. Scheduled to undergo tonsillectomy 3. Signed informed consent by subject Subjects undergoing: 1. Simultaneous adenoidectomy 2. Tonsillectomy as a result of cancer 3. Unilateral tonsillectomy 4. Current participation in other clinical trials 2. Subjects with: 1. Current tobacco use 2. Known bleeding disorders 3. History of peritonsillar abscess 4. Craniofacial disorders 5. Down syndrome (Trisomy 21) 6. Cerebral palsy 7. Major heart disease (including but not limited to; right-sided heart failure, left-sided heart failure, congestive heart failure, coronary artery disease, arrhythmias, chronic heart failure, acute heart failure, etc.) 8. Subjects unable to comply with the required study follow-up visits 9. Pregnancy 3. The subject has comorbidities which, in the opinion of the investigator, will not be appropriate for the study or the subject has an estimated life expectancy of less than 6 months 4. Any subject who is considered to be part of a vulnerable population (e.g. prisoners or those without sufficient mental capacity) 5. The subject has participated in any drug or device research study within 30 days of enrollment
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 1.0-31.0, B Acute Lymphoblastic Leukemia Central Nervous System Leukemia Ph-Like Acute Lymphoblastic Leukemia Testicular Leukemia Patients must be enrolled on APEC14B1 and consented to Screening on the Part A consent form prior to enrollment on AALL1131 White Blood Cell Count (WBC) Age 1-9.99 years: WBC >= 50 000/uL Age 10-30.99 years: Any WBC Age 1-30.99 years: Any WBC with Testicular leukemia CNS leukemia (CNS3) Steroid pretreatment Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible Organ function requirements for patients with Ph-like ALL and a predicted TKI-sensitive mutation: patients identified as Ph-like with a TKI-sensitive kinase mutation must have assessment of organ function performed within 3 days of study entry onto the dasatinib arm of AALL1131 With the exception of steroid pretreatment or the administration of intrathecal cytarabine, patients must not have received any prior cytotoxic chemotherapy for either the current diagnosis of B-ALL or any cancer diagnosed prior to the initiation of protocol therapy on AALL1131; patients cannot have secondary B-ALL that developed after treatment of a prior malignancy with cytotoxic chemotherapy; patients receiving prior steroid therapy may be eligible for AALL1131 Patients with BCR-ABL1 fusion are not eligible for post-induction therapy on this study but may be eligible to enroll in a successor Children's Oncology Group (COG) Philadelphia positive (Ph+) ALL trial by day 15 Induction DS HR B-ALL patients with Induction failure or BCR-ABL1 Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have been noted for several of the study drugs Lactating females are not eligible unless they have agreed not to breastfeed their infant Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Aphthous Stomatitis Patients suffered from recurrent aphthous stomatitis at least once a month People do not have a experience of recurrent aphthous stomatitis
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-75.0, Gastric Adenocarcinoma Esophageal Squamous Cell Carcinoma Nasopharyngeal Carcinoma Head and Neck Squamous Cell Carcinoma "Inclusion Subjects may be entered in the study only if they meet all of the following 1. Fully understand the study and signed the Informed Consent Form (ICF) voluntarily; 2. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet the following conditions (not applicable to cohort 5, 6, 7, and 8): Subjects with gastric adenocarcinoma must have received at least one line of anti-tumor treatment for advanced gastric adenocarcinoma and have documented tumor progression or be intolerable to the current available chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant chemotherapy of radical operation are eligible to this study; Subjects with esophageal squamous cell carcinoma must have received at least one line of treatment for advanced esophageal squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to the current chemotherapy regimen. Subjects who have recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant therapy (including but not limited to chemotherapy or radio-chemotherapy) of radical operation are eligible to this study; Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma who have received at least one line of treatment for advanced nasopharyngeal carcinoma or head and neck squamous cell carcinoma (including but not limited to anticancer drug treatment or radio-chemotherapy) and have documented tumor progression or be intolerable to other current chemotherapy regimens. Subjects with recurrence or metastasis within 6 months after completion of concomitant adjuvant or neoadjuvant radio-chemotherapy of radical operation are eligible to this study (only applies for Version 4.1 and the previous ones); while for the working protocol version 5.0, subjects with nasopharyngeal carcinoma can be enrolled only if they meet the following subjects having received at least two lines of treatment for advanced nasopharyngeal carcinoma (including but not limited to anticancer drug treatment and radio-chemotherapy), who are confirmed to have tumor progression or be intolerable to other current chemotherapy regimens; adjuvant or neoadjuvant radio-chemotherapy after radical surgery can be considered as one line of treatment if tumor recurrence or metastasis occurred within 6 months after the end of the radio-chemotherapy. 3. At least one measurable lesion (according to 1.1); Note: Any lesion which received radiotherapy treatment previously cannot be regarded as a target lesion, unless that it has definitely progressed after radiotherapy. 4. Agree to provide archived tumor tissue specimens or have biopsy to collect tumor tissues for PD-L1 IHC measurement in the central laboratory; 5. Males or females aged between 18 and 75 years old; 6. ECOG score of 0-1; 7. Life expectancy ≥ 3 months; 8. The results of laboratory tests performed within 7 days prior to enrollment must meet the following 1. Neutrophils ≥ 1.5×109/L (not applicable to cohort 5, 6, 7, and 8); 2. Platelets ≥ 75×109/L (not applicable to cohort 5, 6, 7, and 8); 3. Hemoglobin ≥ 90 g/L (without receiving infusion of concentrated red blood cells within 2 weeks); 4. Serum creatinine ≤ 1.5× upper limit of normal (ULN), or creatinine clearance > 50 mL/min (not applicable to cohort 5, 6, 7, and 8); 5. Serum total bilirubin ≤ 1.5×ULN (total bilirubin ≤ 3×ULN are acceptable for subjects with Gilbert syndrome); 6. Both AST and ALT ≤ 2.5×ULN; ALT and AST ≤ 5×ULN are acceptable for subjects with liver metastasis; 9. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 60 days after the end of study treatment. Women of childbearing potential are defined as women with sexual maturity, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) (not applicable to cohort 5, 6, 7, and 8). Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Other special for cohort 5, 6, 7, and 8. 1. Subjects with histologically and/or cytologically confirmed advanced and/or metastatic gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma, who meet any of the following conditions: 1. Subjects who have not received any systematic treatment. 2. Subjects who have received any neoadjuvant chemotherapy, adjuvant chemotherapy for the purpose of curing must experience a period for at least 6 months from the end of the last chemotherapy to tumor progression. 3. Subjects with head and neck squamous cell carcinoma must have received radiotherapy for the purpose of curing, and the period from the end of radiotherapy to tumor progression must be at least 1 year. 4. For subjects with gastric carcinoma, Her2 negative is required. HER2 positive is defined as IHC 3+ or IHC 2+ combined with ISH+, and ISH positive is defined as the ratio of the number of HER2 gene copies to the number of CEP17 signals ≥ 2.0. 2. Results of laboratory test conducted within 7 days before enrollment must meet the following 1. Neutrophils ≥ 2×109/L; WBC count ≥ 4×109L and < 15×109/L 2. Platelets ≥ 100×109/L; 3. Hemoglobin ≥ 90 g/L (no infusion of concentrated red blood cells within 2 weeks); 4. Creatinine clearance rate > 60 mL/min, based on the predicted value of Cockcroft-Gault glomerular filtration rate: (140 age) × (weight, kg) × (0.85, if females) 72× (serum creatinine, mg/dL) Or: (140 age) × (weight, kg) × (0.85, if females) 0.818 × (serum creatinine, μmol/L) 5. Serum total bilirubin ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN are acceptable for subjects with Gilbert syndrome); 6. INR and aPTT ≤ 1.5 × ULN, applies only to subjects who have not received anticoagulation; and for subjects who are receiving anticoagulation, the dose for anticoagulation must be stable. 3. Serum pregnancy test result must be confirmed as negative for women of childbearing potential within 28 days prior to enrollment and the subjects must agree to take effective contraception measures throughout the study treatment period until 6 months after the end of chemotherapy or 60 days after the end of study treatment (whichever comes last). Women of childbearing potential are defined as women with sexual maturities, who meet any of the following conditions: 1) no hysterectomy or bilateral oophorectomy; 2) without natural menopause for a consecutive 24 months (patients with menopause after cancer treatment may also have childbearing potential) (i.e. menstruation occurred at any time during the previous consecutive 24 months) . Female partners of childbearing potential of the male subjects should also follow the contraception requirements. Subjects fulfilling any of the following conditions cannot be enrolled in the study: 1. Known hypersensitivity to citric acid monohydrate, dihydrate sodium citrate, mannitol or polysorbate (components of the investigational drug); 2. Anti-tumor treatment with cytotoxic drugs, biological drugs (e.g. monoclonal antibody), immunotherapy (e.g. interleukin 2 or interferon), or other investigational drugs within 4 weeks prior to enrollment; 3. Tyrosine kinase inhibitor treatment within 2 weeks prior to enrollment; 4. Radiotherapy within 4 weeks prior to enrollment, or radioactive drugs within 8 weeks prior to enrollment. However, patients receiving local palliative radiotherapy for bone metastasis lesions can be included; 5. Subjects with any major surgical operation within 4 weeks prior to enrollment or who have not completely recovered from the prior operation (for the definition of major surgical operation, please refer to the Level 3 and Level 4 operations stipulated in the Management of Clinical Application of Medical Technology enforced on May 1, 2009); 6. Toxicity due to any previous anticancer treatment has not recovered to CTCAE Grade 0-1, excluding the following conditions: 1. Alopecia; 2. Pigmentation; 3. Peripheral nerve toxicity recovered to < CTCAE Grade 2 (not applicable to cohort 5, 6, 7, and 8, subjects are not eligible if peripheral neurotoxicity does not restore to normal); 4. Long-term toxicity related to radiotherapy, which will not fully recover as judged by the investigator. 7. Central nervous system metastasis with clinical symptoms (e.g. brain edema, hormone intervention required, or progression of brain metastasis) and/or carcinomatous meningitis. Subjects with prior treatment for brain or meningeal metastasis can be included if they have remained stable clinically for at least 2 months and systemic hormone treatment (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) has been discontinued for more than 4 weeks; 8. Subjects with nasopharyngeal carcinoma or head and neck squamous cell carcinoma, who are found to have necrotic lesions by examination within 4 weeks prior to enrollment, for which there is a potential risk of massive hemorrhage as judged by the investigator; 9. Previous or other concurrent malignant tumors (expect for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors which were effectively controlled without treatment over the past 5 years); 10. Any active autoimmune disease or history of any autoimmune disease (including but are not limited to interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism or hypothyroidism. Patients with vitiligo or asthma (in childhood) which was completely resolved and without need of any intervention in adulthood can be included. However, subjects with asthma which needs bronchodilator for medical intervention cannot be included); 11. Previous treatments with anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody which acts on T-cell co-stimulatory or checkpoint pathway); 12. Subjects diagnosed with active tuberculosis (TB), who are receiving anti-tuberculosis therapy or used to have anti-tuberculosis therapy within 1 year prior to screening; 13. Concomitant diseases requiring long-term treatment with immunosuppressive drugs, or corticosteroids at an effective immunosuppressive dose (Prednisone at a dose of > 10 mg/day or other equivalent hormone formulations) for systemic or local treatment purpose; 14. Subjects who have received any anti-infection vaccine (e.g. influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment; 15. Pregnant or lactating women 16. Positive test for HIV; 17. Positive test for HBsAg, with HBV DNA copies detected as positive (quantitative measurements ≥ 1000 cps/mL); 18. Positive test for chronic Hepatitis C in blood screening test (HCV antibody positive); Any other clinical significant disease or condition, which as evaluated by the investigator, may affect the protocol compliance, signing of inform consent form (ICF), or not suitable to participate into this clinical trial
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Avian Influenza H1N1 Influenza Influenza Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 18 to 49 years old, inclusive. 4. Are in good health*. *As determined by medical history and targeted physical examination, if indicated based on medical history, to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, that would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days. This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject ), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.4 degrees F. 6. Pulse is 50 to 115 bpm, inclusive. 7. Systolic blood pressure is 85 to 150 mm Hg, inclusive. 8. Diastolic blood pressure is 55 to 95 mm Hg, inclusive. 9. Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour. 10. Women of childbearing potential* must use an acceptable contraception method** from 30 days before first study vaccination until 60 days after last study vaccination. *Not sterilized via tubal ligation, bilateral oophorectomy, hysterectomy or successful Essure (R) placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal. **Includes, but is not limited to, non-male sexual relationships abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing (R), and licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination Have an acute illness*, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination. *An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation*. *Including acute or chronic medical disease or condition, defined as persisting for at least 90 days that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this study. 3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. 4. Have known active neoplastic disease (excluding non-melanoma skin cancer) or a history of any hematologic malignancy. 5. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. 6. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccines. 7. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines. 8. Have a personal or family history of narcolepsy. 9. Have a history of Guillain-Barré syndrome. 10. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. 11. Have a history of a potentially immune-mediated medical condition. 12. Have a history of alcohol or drug abuse within 5 years prior to study vaccination. 13. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 14. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination. 15. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. 16. Have taken high-dose inhaled corticosteroids within 30 days prior to study vaccination. High-dose defined as >840 mcg/day of beclomethasone dipropionate CFC or equivalent. 17. Received licensed live vaccine within 30 days prior to the first study vaccination, or plans to receive licensed live vaccine within 30 days before or after each study vaccination. 18. Received licensed inactivated vaccine within 14 days prior to the first study vaccination, or plans to receive licensed inactivated vaccine within 14 days before or after each study vaccination. 19. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 90 days prior to study vaccination. 20. Received an experimental agent* within 30 days prior to the first study vaccination, or expects to receive an experimental agent** during the 13-month study-reporting period. *Including vaccine, drug, biologic, device, blood product, or medication. **Other than from participation in this study. 21. Are participating or plan to participate in another clinical trial with an interventional agent* that will be received during the 13-month study-reporting period. *Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 22. Prior participation in a clinical trial of influenza A/H7 vaccine* or have a history of influenza A/H7 virus actual or potential exposure or infection prior to the first study vaccination. *And assigned to a group receiving influenza A/H7 vaccine, does not apply to documented placebo recipients. 23. Prior participation in a clinical trial of influenza A/H3N2v vaccine* or have a history of influenza A/H3N2v virus actual or potential exposure or infection prior to the first study vaccination. *And assigned to a group receiving influenza A/H3N2v vaccine, does not apply to documented placebo recipients. 24. Occupational exposure to or substantial direct physical contact* with birds in the past year or during the 28 days after each study vaccination. *Casual contact with birds at petting zoos or county or state fairs or having pet birds does not subjects from study participation. 25. Occupational exposure to or substantial direct physical contact* with pigs in the past year or during the 28 days after each study vaccination. *Casual contact with pigs at petting zoos or county or state fairs does not subjects from study participation. 26. Female subjects who are breastfeeding or plan to breastfeed at any given time from the first study vaccination until 30 days after the last study vaccination. 27. Plan to travel outside the US (continental US, Hawaii, and Alaska) within 28 days after each study vaccination. 28. Blood donation or planned blood donation within 30 days before enrollment until 30 days after the last blood draw for this study
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Heart Failure With Normal Ejection Fraction Preserved left ventricular systolic function on echocardiography (LVEF>50%) Evidence of diastolic dysfunction by echocardiography (E/e'>15) Symptoms of heart failure NT-proBNP levels >300 pg/ml absence of permanent atrial fibrillation acute multi-organ failure history of any malignant disease within 5 years diminished functional capacity due to non-cardiac co-morbidities (COPD, PAOD, morbid obesity) pregnancy
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-40.0, Cesarean Scar Diverticula Patients are younger than 40. 2. Clearly diagnosed with CSD. 3. Experiencing clinical features of abnormal uterine bleeding, prolonged menstrual flow (the duration of menstruation is more than 7 days). 4. The thickness of the remaining muscular layer of CSD was less than 3 mm. 5. The women are at least 20 years old with singleton pregnancies and had undergone a cesarean delivery after at least 37 weeks of gestation. 6. The medicine conservative treatment is invalid. 7. Refusing or use birth control pills contraindications. 8. No serious medical problems (important viscera function in the normal range). 9. No uterine fibroids, endometriosis, adenomyosis, and patients with ovarian cysts. 10. No gynaecology or other malignant tumors. 11. Sign the informed consent Over the age of 40; 2. Indefinite diagnosis. 3. The absence of clinical manifestations of CSD. 4. The presence of menstrual irregularities before cesarean delivery. 5. Coagulation disorders. 6. Malignant tumors. 7. With severe medical problems (severe liver disease, kidney disease, respiratory diseases, heart disease or uncontrolled diabetes, epilepsy, etc., dysfunction of important organs). 8. Known chronic inflammatory diseases, any other uterine diseases (such as uterine fibroids, endometriosis and adenomyosis), uterine surgery except cesarean section. 9. Use of intrauterine devices. 10. Unwilling to comply with the research plan
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Myocardial Infarction Peritoneal dialysis patients whose followed up at least six months from October 1994 to October 2011 (for study group) Kidney transplant recipients whose followed up at least six months from October 1994 to October 2011 (for control group) diabetes mellitus valvular heart disease any prior coronary intervention and congestive heart failure Patients whose left anterior descending coronary artery (LAD) could not be visualized adequately by Doppler echocardiography were also excluded
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Hyperlactatemia Healthy adult volunteers years and older Pregnancy or currently breast-feeding Prisoner History of conditions associated with fluid overload: heart, renal or hepatic failure Baseline serum lactate level >2.2mmol Baseline creatinine > 1.5 mg/dL
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Stress Disorders, Post-Traumatic Intimate Partner Violence Alcohol-Related Disorders Female Veterans Lifetime history of ST with at least one risk factor: heavy drinking within the past 3 months, screen positive for current PTSD or for IPV within last 12 months Age 18-65 Seeking treatment through the Women's Primary Care Clinics at the Central Texas VA Healthcare System Ability to understand study procedures in English Not actively in suicidal or homicidal crisis warranting imminent hospitalization
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Influenza Healthy males or healthy non-pregnant females (as indicated by a negative blood pregnancy test done during the screening visit) between the ages of 18 and 60 years, inclusive Women of childbearing potential (not surgically sterile or postmenopausal for greater than or equal to one year) and men must agree to practice appropriate contraception (a combination of barrier and hormonal methods for women and a condom for men) from screening and until at least 30 days (up to Study Day 51 for females) and 90 days (up to Study Day 111 for males), after the last vaccination A subject is in good health, as determined by a comprehensive clinical assessment {vital signs (heart rate, blood pressure, oral temperature)}, blood chemistry test (electrolytes, renal/kidney function, liver function, C-reactive protein, complete blood count), medical history, general physical examination, self-reported illness} and the clinical judgment of the investigator Able to understand and comply with planned study procedures Provides signed informed consent form Has a known allergy to any of the components of the vaccine Has a history of severe reaction following immunization Persons with immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease, or immunosuppressive therapy Women who have a positive pregnancy test during the screening visit or who are breastfeeding Has a history of any of the following (reported by subjects) Acute disseminated encephalomyelitis (ADEM) Neoplastic disease current or previous Asthma or severe allergic disease Bleeding disorders
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-100.0, Valvular Heart Disease Stenosis and Regurgitation (Diagnosis) Presence of aortic stenosis, mitral or aortic regurgitation at the time of an echocardiography at the "Cliniques Universitaires Saint Luc"
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 21.0-999.0, Influenza-Like Illness Influenza Adult patients 21 years of age or older Presenting to the BMC main ED or Urgent Care area with influenza-like illness Physician ordered an influenza A/B diagnostic test Previously enrolled in the study Any Influenza test result already available at the time approached by the ED RA Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test Unable to give informed consent
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-50.0, PostTraumatic Stress Disorder Able to give informed consent Right-handed Age between 18-50 years old Physically and neurologically healthy [confirmed by a comprehensive medical history] Current PTSD diagnosis clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol any current (or within past 2 months) medical condition requiring medication that would interact with dronabinol or interfere with the study protocol risk of harm to self or others that requires immediate intervention presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances (dronabinol/marijuana/cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide) lack of fluency in English positive drug screen or alcohol breathalyzer unwilling/unable to sign informed consent document currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women) under 18 or over 50 years of age traumatic brain injury (as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement (i.e., whiplash) without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.096-0.135, Poliomyelitis Infants of 6 weeks of age (-7 to + 7 days) on date of first vaccination Healthy, as assessed from medical history and physical examination by a study physician Written informed consent obtained from parents or legal representatives that they have been properly informed about the study and are able to comply with planned study procedures Vaccinated with any poliovirus vaccine prior to A household contact with OPV vaccination history in the past 4 weeks HIV infection or pharmacologic immunosuppression Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde) Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and intradermal injections Acute severe febrile illness on day of vaccination deemed by the Investigator to be a contraindication for vaccination Not suitable for or is unlikely to comply with the protocol in the opinion of the investigator
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Healthy Willing and able to provide written informed consent Healthy men or women based on history, physical examination, laboratory examination and ECG Negative serum or urine pregnancy test result (sensitivity of 25 mIU or better) for women with childbearing potential within the 24-hour period before the first dose of study drugs Female patients with childbearing potential (menopause within 1 year) must agree to use two reliable forms of effective non-hormonal contraception (i.e., condoms, cervical barriers, intrauterine device, spermicides, or sponge), at least 1 of which must be a physical barrier method, during treatment and for at least 6 months following the last dose of ribavirin All male patients with female partners of childbearing potential must use two reliable forms of effective contraception (combined) during treatment and for 6 months following the last dose of ribavirin Others as specified in the detailed protocol Have medical history, or has disease, such as cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, nerve system disease or psychiatric disease and acute or chronic infectious diseases and malignant tumors Has a history of drug or food allergy Positive hepatitis A antibody，positive hepatitis B surface antigen， positive hepatitis C antibody，syphilis antibody or HIV antibody at screening Had gastrointestinal surgery, vagotomy, intestinal resection or any possible interference with gastrointestinal peristalsis, pH or absorbed by surgery Pregnant, lactating or menstrual period and unwilling to reliable contraception period women of childbearing age Female partners have fertility and reliable contraceptive measures of men
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Resuscitation Pediatrics To be nurse certified To know how to prepare intravenous drugs injection To have previously completed the 5-minute introductory course to the use of PedAMINES dispensed by the investigators of the study Participation agreement To have at any time undergone a previous experiment with a cognitive numeric device aimed to help vasoactive drugs preparation To have not undergone the 5-minute introductory course to the use of PedAMINES
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-55.0, Diabetes Mellitus The patient is a pregnant female 18 years of age or older 2. The patient has been diagnosed with gestational diabetes or is a patient with known diabetes and a confirmed viable pregnancy 3. The pregnancy has a singleton pregnancy 4. The patient has access to a cellular phone with a text messaging plan The patient does not have a cellular phone 2. The patient becomes hospitalized for a pregnancy complication for the remainder of pregnancy 3. The fetus has a chromosomal or non-chromosomal malformation
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Melanoma patients with melanoma: diagnosed by pathology and ready for surgery patients with melanoma: refuse or cannot endure surgery pregnant women
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Influenza Aged between 18 and 49 years of age (inclusive). 2. Female subjects must fulfill one of the following: (i) not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) or (ii) agrees to practice effective methods of contraception that may but are not limited to abstinence, barrier methods, monogamous relationship with vasectomized partner, birth control pills, patches, hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices), from 30 days prior to study enrollment through 30 days following receipt of the last dose of vaccine. 3. Female subjects of childbearing potential must have a negative pregnancy test (urine or serum) within 24 hours prior to vaccination. 4. The subject must be in good health, as determined by: vital signs (heart rate >55 to <100 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤150 mm Hg; diastolic ≤ 90 mm Hg; oral temperature <100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. 5. The subject is able to understand and comply with the planned study procedures, including being available for all study visits. 6. The subject has provided informed consent prior to any study procedures. 7. Subjects who have not received seasonal flu vaccine for the current year Subject report of known hypersensitivity to allergy to components of the study vaccine or other components of the study vaccine. 2. Subject report of known latex allergy 3. Subject report of a history of severe reactions following previous immunization with licensed or unlicensed influenza virus vaccines. 4. Subject report of a history of Guillain-Barre syndrome within 6 weeks of receipt of a previous influenza vaccine. 5. The subject is a woman who is pregnant or breastfeeding or intends to become pregnant during the study period between enrollment and 30 days following receipt of vaccine. 6. The subject is immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. 7. The subject has an active neoplastic disease (excluding non-melanoma skin cancer or prostate cancer that is stable in the absence of therapy) or a history of any hematological malignancy. For this criterion, "active" is defined as having received treatment within the past 5 years. 8. The subject has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed). 9. The subject received immunoglobulin or another blood product within the 3 months prior to enrollment in this study. 10. The subject has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days. 11. The subject has an acute or chronic medical condition that, in the opinion of the investigator or appropriate sub-investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions any acute or chronic medical disease or conditions defined as persisting for 3 months (defines ad 90 days) or longer, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses of the subject's successful completion of the study. 12. Subjects with an active infection or that has an acute illness or an oral temperature greater than 99.9F (37.7C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolved > 3 days prior to enrollment. 13. The subject is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period. 14. The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. 15. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years. 16. The subject has a diagnosis of schizophrenia, bi-polar disease, or other severe (disabling) chronic psychiatric diagnosis, or is receiving psychiatric drugs. Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment without decompensation are allowed enrollment into the study. 17. The subject has a history of alcohol or drug abuse in the 5 years prior to enrollment. 18. The subject has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection. 19. The subject has any condition that the principal investigator (PI) believes may interfere with successful completion of the study
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Drug Hypersensitivity Patients seen in consultation in allergology department for suspicion of allergy to beta lactamines patient refusal to take part in the study pregnancy breast feeding women contraindication to provocation test
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Sepsis Newborn Infection Infants admitted to the NICU at participating sites for > 2 days until discharge Babies requiring contact precautions due to other reasons (as glove based care would be occurring)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-48.0, Edema Subjects with recurrent tonsillitis but no sleep apnea Subjects older than eighteen years old Subjects were planned to have only tonsillectomy procedure Subjects who must have additional procedures other than tonsillectomy Subjects younger than eighteen years old Subjects that had intravenous dexamethasone administration perioperatively
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-70.0, Cervical Cancer criteria. 1. Patients who give their written consent to participate in the study. 2. Women, 18-70 years of age, considering the following • In women of childbearing age: i. Negative serum pregnancy test at baseline (14 days prior to the start of QT-RT). ii. The patient must accept the use of any contraceptive method approved by the attending physician during the study and 12 weeks after the end of treatment. • Postmenopausal women must meet at least one of the following parameters for i. Prior bilateral oophorectomy ii. Age ≥ 60 years iii. Age < 60 years, with amenorrhea for at least 12 months and levels of follicle stimulating hormone and estradiol within postmenopausal parameters. 3. Diagnosed with CC IB2-IVA, with or without retroperitoneal lymph nodes (para-aortic), smaller than 2 cm. 4. With histologic confirmation of squamous carcinoma, adenosquamous carcinoma, adenocarcinoma or glassy cells carcinoma. 5. Without previous treatment and medically able to receive gemcitabine. 6. Disease measurable by CT and/or MRI according to (v1.1) criteria. 7. Functional status of 0-3 according to WHO criteria. 8. Renal dysfunction defined by glomerular filtration (GF) <60 ml/min/1.73m2 calculated by the CKD-EPI formula. 9. Normal hematologic and liver function, as defined by the following parameters Hemoglobin > 10g/L. (Transfusion prior to the treatment is allowed to reach this level of hemoglobin) Leucocytes > 4000/mm3 Platelets > 100,000/mm3 Total Bilirubin ≤1.5 times the upper normal limit (UNL) Transaminases < 1.5 times the UNL. 10. Normal PA chest radiograph 1. Patients with prior or concomitant malignancy, except non-melanoma skin carcinoma. 2. Patients with diabetes and/or hypertension with retinopathy or albuminuria >300. 3. Patients with evidence of active TB infection. 4. Patients infected with Human Immunodeficiency Virus (HIV). 5. Patients with a history of Systemic Lupus Erythematosus and other rheumatologic diseases that cause kidney damage. 6. Patients with vesicovaginal or vesicorectal fistula at the time of diagnosis. 7. Patients with uncontrolled intercurrent diseases including active infections that contraindicate QT, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, decompensated diabetes, difficult control hypertension and psychiatric illness. 8. Concomitant treatment with other experimental drugs. 9. Social, family or geographical conditions that suggest a poor adherence to the study. Study discontinuation criteria. 1. Evidence of disease progression, if the researcher considers that the patient would benefit more with other therapy. 2. At the request of the patient. 3. By unacceptable toxicity. 4. Pregnancy. Violation of starting criteria. must be followed punctually. If a patient were inappropriately included, she must be discontinued from the study
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Dental Hygiene years old and older, having a good understanding of French language (read, write, speak, listen) With at least 20 teeth, including 4 first molars and 4 first or second premolars (4 interdental sites between premolars and molars) Patient attending an appointment in a centre participating to the trial Patient able to support treatment Patient affiliated to a health insurance scheme Patient giving his informed consent and accepting the modalities of the study Patient agreeing to attend up to 4 appointments dedicated to the study, during 8 weeks after the initial appointment (motivational interview) Patient in possession of an internet-enabled smartphone or tablet Patient has a personal e-mail address Patient agreeing to be registered within the system of text-based recalls for the duration of the study Patient having previously benefited from a periodontal therapy (less than 1 year ago) or currently enrolled in a periodontal therapy program Patient having previously benefited from an oral hygiene motivation session less than 1 year ago Patient has had a calculus removal procedure less than 1 month ago Patient bears orthodontic appliances (any kind, for 1 or both arches) Patient bears removable dental prosthesis (any kind, for 1 or both arches) Patient allergic to benzoic acid preservatives (or thought to be) Patient has a high risk of infective endocarditis Patient benefiting from antiaggregant or anticoagulation therapy Patient is haemophilic Patient is unable to answer questions
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Primary Sjögren Syndrome Patients with a diagnosis of PSS according to the of the American-European Society for the classification of Primary Sjögren's Syndrome (Vitali et al., 2002) Female gender Aged above 18 years Patients who had cognitive difficulties, with diagnosis of Secondary Sjögren's Syndrome A regular physical exercise practitioner or who were practicing physical exercise regularly up to 2 months before the interview Patients in clinical conditions that prevented the practice of physical exercise according to previous medical evaluation, such as decompensated diabetes mellitus, decompensated thyroid disease, severe cardiorespiratory diseases, etc Use of medications that interfere with physical aspects, especially in response to the sensation of fatigue
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Bipolar Disorder Obesity Men and women, ages of 18-65 years, inclusive. 2. Participants will have a DSM-5 bipolar disorder that is clinically stable. 3. Participants will have received a stable major psychotropic drug regimen (except for minor dosage adjustments) for at least 3 months prior study entry. Major psychotropic drugs are antipsychotics, mood stabilizers, and antidepressants. Subjects may have had changes in adjunctive benzodiazepines and hypnotic agents. 4. Participants will be obese (defined as a BMI ≥ 30 mg/kg2) or overweight (defined as BMI ≥ 27 kg/m2) with at least one weight-related comorbidity, such as hypertension, type 2 diabetes, or dyslipidemia. 5 Participants in treatment for a weight-related comorbidity (hypertension, type 2 diabetes, and/or dyslipidemia) must be on a stable and allowed treatment regimen for that condition for at least 3 months prior to study enrollment. 6 Participants will be able to provide informed consent before any trial-related activities Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. The following are considered to be adequate methods of birth control: 1.Intrauterine device (IUD); 2. Barrier protection; 3.Contraceptive implantation system (Norplant); 4.Oral contraceptive pills; 5. A surgically sterile partner; and 6. Abstinence. Women who are > 2 years post-menopausal or surgically-sterile are not considered of childbearing potential. All female participants will have a negative pregnancy test prior to randomization. 2. Participants who have made a suicide attempt in the last 10 years, who are displaying clinically significant psychotic features, suicidality, or homicidality on mental status examination, or who have suicidal ideation or behavior as assessed with the C-SSRS. 3. Participants who are receiving behavioral weight loss treatment (BWLT) (e.g., Weight Watchers) that was begun within the 3 months before study entry. Participants who are receiving BWLT that was started 3 months prior to the beginning of the study will be allowed to continue to receive their BWLT during the trial only if they have had no weight loss in the past 3 months and they agree to not make any changes in the frequency or nature of their BWLT during the course of the drug trial. 4. A DSM-5 diagnosis of a substance-related or addictive disorder (except a tobacco-related disorder) within the 3 months prior to enrollment. 5. A DSM-5 diagnosis of dementia, a psychotic disorder, or a depressive disorder. 6. History of any psychiatric disorder which might interfere with a diagnostic assessment, treatment, or compliance. 7. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, neurological, metabolic, endocrine, or other systemic disease. Clinically stable hypertension, type 2 diabetes, or dyslipidemia are not exclusionary. 8. Have a history of a structural cardiac abnormality, valvular cardiac disease, cardiomyopathy, serious heart rhythm abnormality, coronary artery disease, congestive heart failure, stroke, or other serious cardiovascular problem. 9. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation. 10. Have clinically relevant abnormal laboratory results. 11. Participants requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes anti-obesity drugs, psychostimulants, modafinil or armodafinil, topiramate or zonisamide, and antipsychotics. Participants receiving metformin at a stable dose for ≥ 3 months can be included. 12. Participants receiving GLP-1 based therapies, sodium-glucose co-transporter 2 inhibitors (SGLT2s), thiazolidinediones, sulfonylureas, or insulin. 13. Participants with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. 14. Participants who have received any investigational medication within three months prior to randomization. 15. Participants previously screen-failed or randomised to participate in this trial. 16. Participants who have a known or suspected allergy to liraglutide 3.0 mg sc injection, its constituents, or related products. 17. Participants with a urine drug screen positive for a drug that, in the opinion of the investigator, is being abused. 18. Participants with a past medical history of pancreatitis. 19. Participants who had received any investigational drug within 3 months prior to this trial. 20. Participants who require bariatric surgery or are anticipated to require it during the course of the trial. If such surgery becomes warranted during the study, such patients will be excluded from the primary endpoint analysis
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 65.0-999.0, Influenza Vaccination Immune Response Probiotics Residents in nursing home aged more than 65 years Frequent gastrointestinal diseases, antibiotic treatment during the intervention, allergy to any groups of antibiotics, egg proteins or adjuvants and excipients of the flu vaccine
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-85.0, Breast Cancer Female Thyroid Gland Female patients with histologically or cytologically proven primary breast cancer; 2. Age >18 years; 3. ECOG Performance Status: 0-2; 4. Life Expectancy: 3 months or more; 5. No previous anti-cancer therapy; 6. Be willing to undergo at least four cycles of anthracycline or taxane-based chemotherapy; 7. Adequate hematological, liver, and kidney functions Pregnancy or lactation; 2. History of other malignancy or secondary breast cancer; 3. History of thyroid disease; 4. History of drug addiction or abuse; 5. History of immunodeficiency disease; 6. Treatment with drugs capable of influencing thyroid gland functions within 3 months prior to study entry; 7. Nonmeasurable disease such as un-controlled diabetes, severe cardiovascular and cerebrovascular diseases; 8. Current, recent (within 4 weeks prior to study entry), or planned participation in any other clinical trials; 9. Inability to understand and agree to informed consent
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-55.0, Influenza Healthy males and females aged ≥18 and ≤55 years of age at the point of enrolment. 2. Willingness to remain in isolation for the duration of viral shedding and to comply with all study requirements. 3. The following are applicable to subjects in a heterosexual relationship and female subjects in a same sex relationship (i.e., the do not apply to male subjects in a same sex relationship): 1. True abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception). Or 2. Two forms of effective contraceptive methods among (between) the couple, which are defined as For males: condom with spermicidal foam/gel/film/cream, sterilisation (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate. This applies only to males participating in the study) For females: Women no longer of child bearing potential (post-menopausal females are defined as having a history of amenorrhea for at least 2 years, otherwise they should have documented status as being surgically sterile or post hysterectomy. The latter applies only to females participating in the study). If of childbearing potential, then acceptable forms of contraception Established (a minimum of 2 weeks prior to admission) use of oral, injected or implanted hormonal methods of contraception Placement of an intrauterine device (IUD) or intrauterine system (IUS) Barrier methods of contraception or occlusive cap (diaphragm or cervical/vault caps), both with one of the following spermicidal foam/gel/film/cream/suppository The longevity of contraception is as follows: Males Comply with agreed contraception at entry to quarantine, and continuing until 90 days after the date of viral challenge/last dosing with IMP (whichever occurs last) Mild to moderate arthritis of non-inflammatory origin may be allowed if the subject is not at risk from relative immobility in the Quarantine Unit and does not require regular medication. 11. A documented medical history for a minimum of the last 2 years prior to inoculation Any subjects who have smoked 10 pack years at any time. Of those subjects that have smoked less than 10 pack years at any time, a subject will be excluded: If regular smokers (e.g., smoking every day) at the time of enrolment. If current casual smoker or use of smoking / nicotine-related products, they must agree to refrain from smoking during the in-patient stay 2. Presence of self-reported or medically documented significant medical condition including but not limited to Chronic pulmonary disease (e.g., asthma (except what is stated in 9), COPD) Chronic cardiovascular disease (e.g., cardiomyopathy, congestive heart failure, cardiac surgery, ischemic heart disease, known anatomic defects) Chronic medical conditions requiring close medical follow-up or hospitalisation during the past 5 years (e.g., insulin dependent diabetes mellitus, renal dysfunction, haemoglobinopathies) Immunosuppression, or immunodeficiency or ongoing malignancy Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures) Post infectious or post vaccine neurological sequelae Hyperlipidemia requiring medical therapy per current American College of Cardiology (ACC) and American Heart Association (AHA) guidelines published in 2013. 3. Individual with body mass index (BMI) <18 and >35. 4. Acute illness within 7 days of first vaccine administration day 5. Clinically significant abnormal electrocardiogram (ECG) and/or parameters, as determined by the Investigator 6. Subjects with clinically significant abnormal systolic and diastolic blood pressure or clinically significant abnormal pulse rate. 7. Subject has abnormal pulmonary function as measured by spirometry defined as a forced vital capacity or forced expiratory volume in 1 second (FEV1) < 80% of predicted or peripheral arterial oxygen saturation (SpO2) < 92% on room air. 8. Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals). 9. Known allergy to 2 or more classes of antibiotics (e.g. penicillins, cephalosporins, fluoroquinolones, or glycopeptides). Known allergy to excipients in the challenge virus inoculum 10. Daily or household contact with vulnerable populations. 11. Receipt of any investigational drug within 3 months prior to the planned date of Viral Challenge/first dosing with IMP (whichever occurs first)
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 13.0-24.0, Microbial Colonization Age 13-24 Female sex Seeking contraceptive/ STI services OR has had a child OR is legally married Has had consensual vaginal sex Two years have passed since menses started HIV negative by self-report Willing to refrain from using douches, washes, or other similar feminine hygiene products. (Tampons are allowed) Planning to receive the Depo-Provera shot, -OR Have regular menstrual cycles with at least 21 days between menses and plans to use no hormonal birth control Any other immunodeficiency (e.g. organ transplant recipient) Recently pregnant (within 4 weeks), currently pregnant, or planning to become pregnant within the next 12 months Currently breastfeeding Hysterectomy or a known genital tract anomaly Amenorrhea (except if caused by contraceptive method like the implant) Antibiotic or antifungal use within past 30 days
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 10.0-18.0, Diabetes Mellitus, Type 2 Signed Written Informed Consent Target Population Previously diagnosed with Type 2 Diabetes Mellitus by World Health Organization/ADA HbA1c between 6.5% and 10.5% obtained at screening Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization. For those children on insulin, investigators will confirm that attempts at removing insulin from the subject's therapeutic regimen had been previously made but had not been successful Age and Reproductive Status Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third, but no more than two thirds, female subjects Women of childbearing potential must have a negative pregnancy test within 24 hours prior to the start of study drug Women must not be breastfeeding Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs: saxagliptin, and dapagliflozin, plus 5 half-lives of study drugs or 30 days (whichever is longer), plus 30 days (duration of ovulatory cycle) for a total of 60 days post treatment completion Target Disease Exceptions Presence of Type 1 diabetes, as demonstrated by Preexisting diagnosis of Type 1 diabetes Previous diagnosis of monogenic etiology of Type 2 diabetes Diabetes ketoacidosis (DKA) within 6 months of screening Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified Sixteen weeks: thiazolidinediones, DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors) Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening. Use of prescription or non-prescription weight loss drugs must be stable during the study Medical History and Concurrent Diseases Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Oral Aphthous Ulcer Patients with free medical history and no systemic diseases16 Patients clinically diagnosed as suffering from symptomatic oral minor aphthous ulcers Patients who agreed to take medications Patients suffering from any systemic disease as Crohn's disease, Behcet's disease and others Anemic and leukemic patients (using complete blood count investigation) Patients taking systemic drugs such as systemic steroids and other immunosuppressive therapy Patients treated with any oral topical medications 48h before the study27 Pregnant and lactating mothers
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Influenza Subjects who meet all of the following may be included in the study: 1. Men and women 18 to 49 years of age, inclusive 2. Good general health status as determined by the Investigator 3. Adequate venous access for repeated phlebotomies 4. Screening laboratory results within institutional normal range or Grade 1 elevation if the Investigator documents clinical insignificance. Creatine kinase or bilirubin may be Grade 2 if associated with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and the Investigator considers the result not to be clinically significant due to vigorous exercise or Gilbert's syndrome 5. Negative drug and alcohol screen at Screening and predose on Day 1 6. For women who have not been surgically sterilized or have laboratory confirmation of postmenopausal status, negative pregnancy test 7. Willingness to practice a highly effective method of contraception that may but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with a postmenopausal partner, monogamous relationship with vasectomized partner, vasectomy, surgical sterilization (hysterectomy, or bilateral tubal ligation, salpingectomy, or oophorectomy), licensed hormonal methods, intrauterine device (IUD), or consistent use of a barrier method (eg, condom, diaphragm) with spermicide for 28 days after the NasoVAX/placebo dose 8. Willingness to participate and comply with all aspects of the study through the entire study period, including nasopharyngeal swabs and blood and urine samples 9. Provision of written informed consent Subjects who meet any of the following will be excluded from the study: 1. Pregnant, possibly pregnant, or lactating women 2. Household contacts of pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination 3. Persons who care for pregnant women, children < 5 years of age, or immunocompromised individuals for the period up through 2 weeks postvaccination 4. Body mass index > 35.0 kg/m2 5. Positive results for HIV, hepatitis B virus, or hepatitis C virus at Screening 6. Asthma or other chronic lung disease that is greater than mild in severity. Specifically excluded are participants with the any of the following events in the past year Daily symptoms Daily use of short acting beta 2 agonists Use of inhaled steroids or theophylline Use of pulse systemic steroids Emergency care or hospitalization related to asthma or other chronic lung disease Systemic steroids for asthma exacerbation 7. History of diabetes mellitus (gestational diabetes is allowed if treatment was not required postpartum and serum glucose is currently in the normal range) 8. History of coronary artery disease, arrhythmia, or congestive heart failure 9. Clinically significant ECG abnormality as determined by the Investigator 10. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg) at Screening or predose on Day 1 11. History of anaphylaxis or angioedema 12. Known allergy to any of the ingredients in the vaccine formulation 13. History of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration 14. Previous nasal surgery or nasal cauterization 15. Any symptoms of upper respiratory infection or temperature > 38°C within 3 days before Day 1 16. Any symptoms within 24 hours before Day 1 of upper respiratory illness of allergy flare-up that, in the opinion of the Investigator, presents as nasal congestion or rhinorrhea that could inhibit the proper administration of the IP 17. Known or suspected malignancy, excluding non-melanoma skin cancers and other early stage surgically excised malignancies that the Investigator considers to be exceedingly unlikely to recur 18. Immunocompromised individuals, including those who have used corticosteroids (including intranasal steroids), alkylating drugs, antimetabolites, radiation, immune-modulating biologics, or other immunomodulating therapies within 90 days before Day 1 or those who plan use during the study period 19. Use of statin medication within 30 days before Day 1 (see list in Section 6.8.1) 20. Receipt of intranasal medications (including over-the-counter medications) within 30 days before Day 1 21. Receipt of any investigational product (IP) within 30 days before Day 1 22. Receipt of any vaccine within 30 days before Day 1 23. Receipt of intranasal vaccine within 90 days before Day 1 24. Receipt of any influenza vaccine within 6 months before Day 1 25. Any change in medication for a chronic medical condition within 30 days before Day 1 26. Past regular use or current use of intranasal illicit drugs 27. Smoking of any type (eg, cigarettes, electronic cigarettes, marijuana) or use of any tobacco product within 30 days before Day 1 28. Any medical, psychiatric, or social condition or occupational or other responsibility that in the judgment of the Investigator would interfere with or serve as a contraindication to protocol adherence, assessment of safety (including reactogenicity), or a subject's ability to give informed consent
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-79.0, Renal Impairment Ability to understand and follow study-related instructions and ability to participate in the study for the entire period Age: 18 to 79 years (inclusive) at the screening visit Body mass index (BMI): 18 to 34 kg/m² (both inclusive) Male or female subject Only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy). Subjects with renal impairment eGFR <90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing Stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit. Healthy subjects eGFR ≥90 mL/min/1.73 m*2 determined from serum creatinine 2-10 days prior to dosing Pregnant or lactating women Medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 3.0-12.0, Autism Spectrum Disorder Children aged 3-12 years diagnosed to have mild to moderate autism spectrum disorder diagnosed by childhood autism spectrum disorder(CARS 35% or less) children with otitis media with effusion Associated neurological deficit
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Meningococcal Vaccine Apparently healthy adult of 18 to 45 years of age. 2. Sex: Male, Female and Transgender 3. Apparently healthy based on a medical history taken prior to vaccination. Any underlying chronic illness must be documented to be in stable condition. 4. Women with child bearing potential must be non pregnant which will be confirmed by negative urine pregnancy test during screening and prior to vaccination on day 0 as well. Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely the probability of pregnancy.Women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable Prior history of Meningitis infection or vaccination with any Meningococcal vaccine. 2. Prior history of taking any other polysaccharide vaccine (Pneumococcal Vaccine, Typhoid Vaccine) in last 6 months. 3. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine. 4. Recent febrile illness (within last two weeks). 5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician. 6. Known or suspected hypersensitivity to any component of Meningococcal ACWY polysaccharide vaccine. 7. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g, systemic corticosteroids). Does not topical and inhaled steroids. 8. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 9. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Uterine Bleeding Implant (Jadelle or Implanon) inserted before enrollment with the symptom of bleeding disturbances for eight or more continuous days or a current bleeding-free interval of 15 days or less Regular menstruation at least 1 cycle before the usage of implant contraceptive Willingness to participate in a placebo-controlled study and ability to keep an accurate daily menstrual record No gynecological or serious medical diseases Contraindication to estrogen or progesterone use such as breast cancer Liver cancer or tumor Uncontrolled blood pressure (BP ≥160/100 mmHg ) History of atherosclerosis, vascular disease and high risk for VIE History of ischemic stroke Coagulopathy Uncontrolled diabetes mellitus and complication Cirrhosis SLE with antiphospholipid positive
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Pelvic Gynecological Cancer ≥ 18yrs with pelvic gynecological cancer (endometrium, cervix, ovary) at any stage of the disease patient coming for anesthesia consultation before hysterectomy informed signed consent patient affiliated to or beneficiary of social security patient <18yrs patient with a pelvic gynecological cancer that does not require hysterectomy patient with psychiatric history or a depressive syndrome deaf patient (deafness makes the hypnosis session impossible) patient under legal protection
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 21.0-60.0, Alcohol Drinking Male and female participants between 21-60 years of age. (assessment: identification provided to Clinical Center Admissions office) Smoking status: 1. Smokers will have a history of at least 1 year of daily smoking, defined as individuals who smoke more than 20 uses of nicotinic products/week on average, and a cotinine level, measured by the NarcoCheck PreDosage Nicotine Test (PNT) test, of >= 2. [assessment: Smoking history questionnaire, Additional medical history, PreDosage Nicotine test] 2. Non-smokers with no history of smoking in the past year and less than 20 uses of nicotinic products lifetime.(assessment: smoking history questionnaire, Additional medical history) for women: Use of adequate method of birth control during the study, if female is sexually active and is not surgically sterilized. Adequate methods of contraception use of oral contraceptives; use of barrier method of contraceptive; use of an approved IUD or other long-acting reversible contraceptive (LARC); have a male sexual partner who is surgically sterilized; or have exclusively female sexual partner(s). Justification: To minimize the risk of administering alcohol to pregnant women, given the known effects of alcohol exposure on fetuses. (assessment: medical history) Current or prior history of major medical illness, including CNS, cardiovascular, respiratory, gastrointestinal, hepatic, renal, endocrine, or reproductive disorders. Justification: Many illnesses may alter the neuropsychological effects of alcohol as well as MRI measures. (assessment: clinically significant findings on medical history and physical exam, ECG, laboratory tests) Positive hepatitis (A, B antigen, or C), or HIV test at screening. Justification: Hepatitis can alter liver function and alcohol pharmacokinetics. HIV infection can alter brain function. (assessment: laboratory tests) Current (past 12 months) history of psychiatric disorders, including depressive disorder, bipolar disorder, or anxiety disorders. Justification: Concurrent psychopathology can alter brain function and alcohol response. (assessment: SCID interview) Lifetime history of psychotic disorders, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or eating disorder. Justification: These disorders can have long-term effects on brain function and alcohol response. (assessment: SCID interview) Current or lifetime diagnosis of alcohol or substance use disorder. Justification: History of alcohol or substance use disorder will impact brain function and alcohol response. (assessment: SCID interview) Currently seeking treatment for alcohol use disorders. Justification: It would be unethical to administer alcohol to individuals seeking treatment for alcohol problems. Also, this study does not provide treatment for individuals with alcohol use disorder. (assessment: medical history) History of significant withdrawal symptoms or presence of clinically significant withdrawal symptoms (Clinical Institute Withdrawal Assessment (CIWA) score > 8) at screening. Justification: Withdrawal symptoms would be indicative of alcohol use disorder, which is already an Additionally, withdrawal symptoms would be a major safety concern for participants, and a major confound in the assessment of alcohol response and brain function. (assessment: CIWA assessment) Non-drinkers (alcohol-na(SqrRoot) ve individuals or current abstainers) or individuals with no experience drinking 5 or more drinks on one occasion in their lifetime. Justification: It would be unethical to administer alcohol to individuals that do not drink alcohol. (assessment: medical history) Positive result on urine drug screen or positive breathalyzer during screening visit. Positive urine drug screen or breathalyzer reading during more than 1 study visit will result in participant withdrawal from the study. Justification: Current or recent exposure to alcohol or drugs of abuse could impact brain function and alcohol response. (assessment: laboratory tests and breathalyzer test performed at screening or update visit under 14-AA-0181 most proximal to enrollment)
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Menstrual Cycle Abnormal PCOS Overweight Obesity Aged 18-45 years At least 2y post-menarche BMI >18.5kg/m2 Good visibility of the ovaries on ultrasound Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>35 days); or Previous diagnosis of PCOS from a primary care provider Weight >300lbs Currently pregnant or breast feeding History of ovarian surgery Use of medications or supplements known or suspected to interfere with reproductive function and/or glucose and lipid metabolism in the past 3 months Evidence of reproductive aging as assessed by the principal of STRAW+10 stages
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 19.0-64.0, Avian Influenza Influenza Influenza Immunisation Provide written informed consent prior to initiation of any study procedures. 2. Are able to understand and comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females, 19 -64 years of age, inclusive. 4. Are in good health As determined by medical history and physical examination to evaluate acute or currently ongoing chronic medical diagnoses or conditions, defined as those that have been present for at least 90 days, which would affect the assessment of the safety of subjects or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions should be stable for the last 60 days (no hospitalizations, Emergency Room (ER), or urgent care for condition and no adverse symptoms that need medical intervention such as medication change/supplemental oxygen). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis or condition in the 60 days prior to enrollment. Any prescription change that is due to change of health care provider, insurance company, etc., or that is done for financial reasons, as long as in the same class of medication, will not be considered a deviation of this criterion. Any change in prescription medication due to improvement of a disease outcome, as determined by the site principal investigator or appropriate sub-investigator, will not be considered a deviation of this criterion. Subjects may be on chronic or as needed (prn) medications if, in the opinion of the site principal investigator or appropriate sub-investigator, they pose no additional risk to subject safety or assessment of reactogenicity and immunogenicity and do not indicate a worsening of medical diagnosis or condition. Similarly, medication changes subsequent to enrollment and study vaccination are acceptable provided there was no deterioration in the subject's chronic medical condition that necessitated a medication change, and there is no additional risk to the subject or interference with the evaluation of responses to study vaccination. Note: Topical, nasal, and inhaled medications (with the exception of inhaled corticosteroids as outlined in the Subject ), herbals, vitamins, and supplements are permitted. 5. Oral temperature is less than 100.0°F. 6. Pulse is 47 to 100 beats per minute (bpm), inclusive. 7. Systolic blood pressure is 85 to 150 mmHg, inclusive (subjects <65 years of age), 85 to 160 mmHg, inclusive (subjects = / > 65 years of age). 8. Diastolic blood pressure is 55 to 95 mmHg, inclusive. 9. ESR is less than 30 mm per hour. 10. Women of childbearing potential must use an acceptable contraception method from 30 days before first study vaccination until 60 days after last study vaccination Not sterilized via tubal ligation, bilateral oophorectomy, salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented radiological confirmation test at least 90 days after the procedure, and still menstruating or <1 year of the last menses if menopausal. - Includes non-male sexual relationships, abstinence from sexual intercourse with a male partner, monogamous relationship with vasectomized partner who has been vasectomized for 180 days or more prior to the subject receiving the first study vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices, NuvaRing®, and licensed hormonal methods such as implants, injectables, or oral contraceptives ("the pill"). 11. Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study vaccination Have an acute illness, as determined by the site principal investigator or appropriate sub-investigator, within 72 hours prior to study vaccination An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site principal investigator or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. 2. Have any medical disease or condition that, in the opinion of the site principal investigator or appropriate sub-investigator, is a contraindication to study participation Including acute or chronic medical disease or condition, defined as persisting for at least 90 days, that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial. 3. Have immunosuppression as a result of an underlying illness or treatment, a recent history or current use of immunosuppressive or immunomodulating disease therapy. 4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination. 5. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma, treated, skin cancers are permitted. 6. Have known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection. 7. Have known hypersensitivity or allergy to eggs, egg or chicken protein, squalene-based adjuvants, or other components of the study vaccine. 8. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines. 9. Have a personal or family history of narcolepsy. 10. Have a history of Guillian-Barre Syndrome (GBS). 11. Have a history of convulsions or encephalomyelitis within 90 days prior to study vaccination. 12. Have a history of Potentially Immune-Mediated Medical Conditions (PIMMCs). 13. Have a history of alcohol or drug abuse within 5 years prior to study vaccination. 14. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations. 15. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination. 16. Have taken oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to study vaccination. 17. Have taken high-dose inhaled corticosteroids within 30 days prior to each study vaccination High-dose defined per age as using inhaled high dose per reference chart https://www.nhlbi.nih.gov/health-pro/guidelines/current/asthma-guidelines/quick-refere nce-html#estimated-comparative-daily-doses 18. Received a licensed live vaccine within 30 days prior to the first study vaccination, or plan to receive a licensed live vaccine within 30 days before or after each study vaccination. 19. Received or plan to receive a licensed, inactivated, vaccine (excluding all flu vaccines) within 14 days before or after each study vaccination. 20. Received or plan to receive the 2017-2018 inactivated seasonal flu vaccine prior to or during the clinical trial and for the remainder of the 2017-2018 season. 21. Received Ig or other blood products (with exception of Rho D Ig) within 90 days prior to each study vaccination. 22. Received an experimental agent within 30 days prior to the first study vaccination, or expect to receive an experimental agent during the 13-month trial-reporting period Including vaccine, drug, biologic, device, blood product, or medication. - Other than from participation in this trial. 23. Are participating or plan to participate in another clinical trial with an interventional agent that will be received during the 13-month trial-reporting period Including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication. 24. Received or plan to receive an influenza A/H7 vaccine or have a history of influenza A/H7 subtype infection
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Neoplasms, Malignant Breast Neoplasm Carcinoma, Basal Cell Carcinoma, Squamous Cell Melanoma Skin Neoplasm Head and Neck Neoplasms Subject must be capable of giving informed consent or has an acceptable surrogate capable of giving consent on behalf of the subject. 2. Subject has an eligible tumor that is within 5 mm of the surface (either skin or mucosa) or has had a tumor removed with a tumor bed that is within 5 mm of the surface. 1. Eligible tumors types Intraoral tumors: squamous cell carcinoma (SCC), melanoma Primary cutaneous tumors (including, but not limited to): SCC, basal cell carcinoma (BCC,) melanoma Breast malignancies post surgery Other tumors: any tumor within 5 mm of the surface and with planned radiation therapy Previous adverse reaction to a charcoal product e.g., a local hypersensitive response from a black tattoo or from ingestion of activated charcoal 2. Previous adverse reaction to the suspending agent 3. Subject has a pacemaker that is not known to be MRI compatible 4. Subject has a non-removable implant or device with metal that is not known to be MRI compatible 5. Subject is pregnant or has a likelihood for becoming pregnant during the basic study timeframe. Note: There is no known harm to the woman or her fetus from participating; this is precautionary only
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 3.0-13.0, Tonsillitis Healthy patients aged 3-13 years Level I or level II on the American Society of Anesthesiologists (ASA) physical status classification system (as determined by the anesthesiologist) obstructive sleep apnea or recurrent throat infections undergoing elective tonsillectomy with or without adenoidectomy Parents who agree to complete documentation and follow up at 14 days post-operation Patients Level III or greater on the American Society of Anesthesiologists (ASA) physical status classification system (as determined by the anesthesiologist) Patients with chronic conditions that would limit our ability to develop the study according to objectives, such as neurodevelopmental conditions preventing patients from understanding the Oucher tool Hepatic or renal disease cardiac disease active infection diabetes mellitus sickle cell disease known coagulation disorders pre operative treatment with anti-emetics, steroids, or analgesics
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza Solid Organ Transplant Kidney, liver or pancreas transplant recipients on at least one immunosuppressive medication Age ≥ 18 Outpatient status Greater than 30 days post-transplant Has already received influenza vaccination for 2017-2018 season Egg allergy or allergy to previous influenza vaccine Febrile illness in the past one week Active Cytomegalovirus viremia Use of Rituximab in the past one year Ongoing or recent (in past 30 days) therapy for acute rejection Chronic kidney insufficiency (creatinine clearance ≤30mL/min or dialysis-dependent Previous life-threatening reaction to influenza vaccine (i.e., Guillain Barre Syndrome) Receipt of intravenous immunoglobulin (IVIG) in the past 30 days or planning to receive IVIG in the next four weeks
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Influenza, Human Patient of client organizations of Emmi Solutions Provided a phone number to their care team
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-999.0, Acne Vulgaris Patient with acne, with at least 10 inflammatory lesions and no more than 3 nodules Patient who already had one cycline course for her acne treatment with a 3 months* wash out or who never had any cycline Patient having signed an informed consent Absence of use of oral antibiotics and Zinc salts in the last 30 days Absence of use of systemic isotretinoin and antiandrogens in the last 6 months Absence of microphysiotherapy in the last 15 da Women of child-bearing age under contraception since 3 months (oral contraception, implant or IUD) Patients with social security Patient affected by active /progressive diseases, as infections including Hidradenitis suppurativa, cancers, or endocrine syndrome (eg polycystic ovary syndrome), Addison's disease) Patient affected by Rosacea Patient with contra-indication to the use of one of the investigational products or auxiliary Patient with intolerance or hypersensitivity to cyclin's, spironolactone or to any ingredient present in associated benzoyl peroxide gel Patient with significant impairment of renal excretory function, acute or chronic renal failure, anuria Patient with life-threatening or very severe hepatic impairment.(grade III or IV) Patient with hyperkalaemia or strongly requiring potassium-sparing diuretics (eg amiloride, canrenoate, eplerenone, triamterene), or treated continuously with Angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II antagonist, NSAIDs, heparin and molecular weight heparin, ciclosporin and tacrolimus Patient requiring topical isotretinoin or who stopped this drug since less than 2 weeks Patient previously treated with spironolactone Pregnant woman or likely to become pregnant or nursing and refusing to use an effective contraceptive method
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Thoracoabdominal Aneurysm patient with ≥ 18 years of age, undergoing total endovascular treatment of thoracoabdominal pathology (single-stage or multi-stage endovascular repair) at San Raffaele Hospital in between October 2013 and December 2020 none
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-59.0, Influenza Flu Aged ≥ 18 to 59 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 Subject is pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non- childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine or planned receipt of any vaccine within the period from 2 weeks before trial vaccination to 2 weeks following trial vaccination Previous vaccination against influenza (in the previous 6 months) with either the trial vaccines or another vaccine Receipt of immune globulins, blood or blood-derived product 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 vaccines components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Self-reported thrombocytopenia contraindicating intramuscular vaccination Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding contraindicating intramuscular vaccination Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Procedural Bleeding Delayed Bleeding Post-Polypectomy Syndrome Post Procedural Complication Sex and age: men and women > 18 years old 2. Subjects referred for EMR of polyps of size ≥11 mm 3. ASA score 1, 2 or 3. 4. Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care). 5. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent Age: Subjects is under 18 years old 2. Consent: Vulnerable subjects including those who are unable to consent 3. Pregnancy: Pregnant or breastfeeding women 4. ASA score <3 5. Physical findings: Abnormal physical findings that may interfere with the study objectives 6. Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days 7. Excluded lesions Lesions less than 11 mm in largest dimension Lesions involving the muscularis propria (T2 lesions) Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma Proven malignant disease locally advanced or with metastasis Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease Endoscopic appearance of invasive malignancy 8. Previous partial resection or attempted resection of the lesion 9. Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs 10. Severe liver disease. 11. Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon, 12. Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease 13. Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR>1.5). 14. Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study. 15. Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 20.0-85.0, Inflammation Men and women between the ages of 20-35 years Men and women between the ages of 65-85 years Regular use of omega-3 nutritional supplements Diabetes or fasting plasma glucose > or equal to 126 mg/dL Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl) Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment) Renal failure (serum creatinine > 1.5mg/dl) Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L) Oral warfarin group medications or history of blood clotting disorders international normalized ratio (INR) >2.01.5 Smoking Pregnancy or breastfeeding
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Cardiovascular Diseases Depression Ability to give informed consent Fluent in English Between the ages of 18-65 Lives in the United States Self-report of having experienced depression as assessed by the Mini International Neuropsychiatric Interview (MINI) Self report an elevated risk for or of having cardiovascular disease ( >150 minutes of physical activity a week and BMI >25) Registered a personal account with Fitbit prior to enrollment in the study Unwilling/unable to comply with study procedures Pregnant A total score of a 20 on the PHQ-9 (indicative of "very severe" depression) and/or a total score of a 16 on the ASRM (or indicative of "very severe" mania) Responds to item 9 (Suicidal ideation) on the PHQ-9 with a 2 or higher (i.e., "Thoughts that you would be better off dead or of hurting yourself in some way on more than half the days") Contraindications to exercise or diet interventions as assessed by the DASI Already owns a fitbit device or other activity monitor Suffers from repeated episodes of "blacking out" or "fainting" Survived a cardiac arrest or sudden death Has recurrent chest discomfort with activity that goes away within 10 minutes of rest or with nitroglycerin Has heart failure
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-49.0, Influenza Age 18-49 years old on the day of screening, having Thai ID card or equivalent Able to read and write in Thai and sign written informed consent form Able to attend all scheduled visits and to comply with all trial procedures Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable, under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination For female participants Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day 60 Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than one year must be willing to use effective contraceptive method to prevent pregnancy until Day 60 after vaccination. Effective methods intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study Hypersensitivity after previous administration of any vaccine Having a history of H1N1, H3N2 or Flu B infection within 3 months preceding enrollment to the trial Vaccination against influenza in the past 6 months preceding enrollment to the trial Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 21 visit History of bronchial asthma, chronic lung diseases, chronic rhinitis History of immunodeficiency state History of immunosuppression < 6 months prior to immunization History of anaphylactic or other allergic reactions to influenza vaccine or any vaccine component or excipient (e.g. gentamicin or thimerosal) History of Guillain-Barré Syndrome
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Recurrent Pregnancy Loss Unexplained Infertility Inclusion/ Recurrent Pregnancy Loss Age 18-45 or more SABs including biochemical pregnancies OR 2 or more SABs if one is documented to be euploid irregular menstrual cycles Submucosal fibroid >3cm Stage 3-4 endometriosis BMI >40 IUD within the last 3 months 2. Unexplained infertility Patients TTC x >= 1 year At least one SA with TMS >10 mil within last 2 years
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-40.0, Obesity Exercise Reinforcement Participants must be overweight to obese (BMI 25-35 kg/m2) Not pregnant or lactating or planning to become pregnant in the next 6 months No limitations to safely participating in physical activity Currently dieting to lose weight and no weight loss or gain >2kg over the past 3 months Taking any medications that affect energy expenditure or eating Regularly exercising (planned and structured aerobic or resistance activity) Participants must have no major health problems, cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease Tobacco use Have a medical condition that prevents safe exercise
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-44.0, Plasma Volume Micronutrients Menstrual Cycle Female to 44 years of age General good health (does not have a known, ongoing health condition/medical issue that requires regular monitoring by a doctor or regular visits to the hospital) BMI 18.5-24.9 kg/m2 Regular menstrual cycle (26-35 days) Non-smoker Non-pregnant If pregnant before, ≥12 months since last pregnancy Known allergy to shellfish or iodine Blood pressure on the day of measurements is low or high (systolic blood pressure (SBP) <90 or ≥130 mmHg and/or diastolic blood pressure (DBP) <60 or ≥80 mmHg) Currently has low or high blood pressure (SBP <90 or ≥130 mmHg and/or DBP <60 or ≥80 mmHg), self-reported Current hypertension or previous hypertensive disorder in pregnancy (gestational hypertension or preeclampsia) Taking regular medication(s) (physician's prescribed medications for a health condition) Currently trying to conceive Currently breastfeeding Currently using hormonal birth control or used within last 3 months Used depot medroxyprogesterone acetate (DMPA) in the past 12 months Diagnosis of polycystic ovary syndrome
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma Recurrent Lung Non-Squamous Non-Small Cell Carcinoma Stage IV Lung Non-Small Cell Cancer AJCC v7 FOR STEP 0 Patients with tumors with the following molecular alterations must submit testing results via Medidata Rave to determine to Arm T; the study chair, co-chair, biology co-chair, or a delegate must review the molecular testing and agree that the testing meets one of the molecular below ROS1 gene rearrangement by fluorescence in situ hybridization (FISH) or deoxyribonucleic acid (DNA) analysis (may have progressed on prior crizotinib therapy) MET exon 14 splice mutations on DNA analysis (may have progressed on prior crizotinib therapy) MET high amplification by FISH or DNA analysis or other MET mutations predicted to be sensitive to MET inhibitor (no prior targeted therapy allowed) RET gene rearrangement by FISH or DNA analysis (no prior targeted therapy allowed) Institutions will be notified of the patient's status for Arm T within two (2) business days of submission of the molecular testing reports If patients do not have tumors with the above molecular alterations noted proceed directly to step 1 FOR STEP 1 For patients with known molecular alterations, institution has been notified that patient is deemed eligible for Arm T per review of molecular testing reports
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-65.0, Vaccination Male and female subjects, aged 18-65 years, who will work with or in the vicinity of a replicating vaccinia virus and who volunteer for the program. Subjects may be vaccinia-naïve or vaccinia-experienced Women of child-bearing potential (WOCBP) must have a negative urine pregnancy test within 48 hours prior to vaccination WOCBP must have used an acceptable method of contraception for at least 30 days prior to the first vaccination and must agree to use an acceptable method of contraception during the vaccination period until at least 28 days after the last vaccination. A woman is considered of child-bearing potential unless post-menopausal or surgically sterilized. (Acceptable contraception methods are restricted to barrier contraceptives which Food and Drug Administration (FDA)-approved spermicides, intrauterine contraceptive devices, or licensed hormonal products.) Read, signed and dated Informed Consent Form Pregnant or breast-feeding women Uncontrolled serious infection i.e., not responding to antimicrobial therapy History of or active autoimmune disease. Persons with vitiligo or thyroid disease taking thyroid replacement are not excluded Known or suspected impairment of immunologic function including, but not limited to, clinically significant liver disease; uncontrolled diabetes mellitus; moderate to severe kidney impairment or post organ transplant subjects History of malignancy, other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered to have achieved cure History of coronary heart disease, myocardial infarction, angina, congestive heart failure, cardiomyopathy, stroke or transient ischemic attack, uncontrolled high blood pressure, or any other heart condition under the care of a doctor History of allergies or reactions to eggs, egg products, or gentamycin Having received any vaccinations or planned vaccinations with a live vaccine within 28 days or a killed vaccine within 14 days prior to or after Chronic administration (defined as more than 6 days) of systemic corticosteroids within 30 days of the first planned vaccination Use of any investigational or non-registered drug or vaccine other than within 30 days preceding the first vaccine dose
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 3.833-5.083, Meningococcal Infections Participated in and completed (attended Visit 2) study MET54 Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations) Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures Covered by health insurance where applicable Participation 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 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2 Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54 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) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) 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 Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Obstetric Complication Postpartum Hemorrhage Postpartum Endometritis Female Able to give consent Gestational age > 24 weeks Postpartum Placement of an IBT within the last 2 hours with plans for it to remain in situ for at least 2 hours Primary obstetrician amenable to proceeding with either method of management during the study period Age < 18 years old IBT removed within 2 hours of placement Chorioamnionitis Insufficient documentation of demographics, delivery outcomes, or peripartum events including postpartum hemorrhage, infectious outcomes
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Acetabular Fracture Acetabular Surgery age> 18 surgery for acetabular fracture within 30 days with dome impaction disability of inferior limb
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, ST Segment Elevation Myocardial Infarction Heart Failure 18+ year old 2. Diagnosis of acute ST-elevation myocardial infarction (STEMI) 3. Primary STEMI 4. Symptom onset of less than 12 hours 5. Admitted to the Royal Alexandra Hospital in Edmonton, Alberta Low risk inferior STEMI (total ST elevation plus depression <4mm) 2. Cardiogenic shock 3. Use of thrombolytics 4. Prior history of myocardial infarction or heart failure 5. Known hypersensitivity to tetracyclines 6. Any concurrent medical condition expected to reduce life expectancy to <1 year 7. Symptom onset to treatment (loading dose) time longer than 24 hours 8. Poor renal function (eGFR<30 mL/min/1.73m2) or other contraindications to MRI (claustrophobia, pregnancy, PPM/ICD, sub-arachnoid clips, retained ocular foreign body)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Coronary Artery Disease The patient must be at least 18 years of age Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered) The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length) Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU Patient provides written informed consent Patient agrees to all required follow-up procedures and visits The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions Previous coronary intervention on target vessel Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment) Lesions not allowing a complete balloon inflation or stent deployment
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Metastatic Malignant Solid Neoplasm Patients with biopsy-proven metastatic solid tumor and be eligible to receive nivolumab per standard of care Patients will be allowed to have any number of prior lines of therapy for metastatic cancer Patients with measurable and non-measurable disease are allowed to participate Absolute neutrophil count (ANC) ? 1.5 x 10^3/mm^3 Hemoglobin (Hgb) ? 9 g/dL Platelet count ? 100 x10^3/mm^3 Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ? 2.5 x upper limit of normal (ULN) or ? 5 x ULN in patients with liver metastases Prothrombin time ? 1.5 x ULN Total bilirubin ? 1.5 x ULN (unconjugated bilirubin of < 3 x ULN for patients with known Gilbert syndrome) Creatinine clearance of ? 50 ml/min by Cockcroft-Gault equation History of prior therapy with ibrutinib or nivolumab Unable to swallow capsules or having disease that is significantly affecting gastrointestinal function and/or inhibiting small intestine absorption Diagnosis of congenital or acquired immunodeficiency with the exception of chemotherapy induced immune suppression Active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids of greater than or equal to prednisone 10 mg/day or other immunosuppressive agents; patients with history of adequately treated Hashimoto?s thyroiditis will be eligible; patients requiring a short course of a high dose prednisone burst to treat asthma or common obstructive pulmonary disease will also be eligible 5 days following completion of the prednisone treatment Use of systemic steroids at a dose above 10 mg/day of prednisone or prednisone equivalent in cycle 1 of study therapy; systemic steroids must be discontinued at least 5 days prior to initiating study therapy; exception will be given to patients who develop immune related adverse events that necessitate use of steroids or other immune suppressive agents; following cycle 1 of study treatment, the use of systemic steroids will be allowed per discretion of the treating physician Active, non-infectious pneumonitis Ongoing or active infection requiring systemic therapy History of being positive for human immunodeficiency virus (HIV) History of hepatitis B or C History of receiving live vaccine within 30 days of planned start of study therapy
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-75.0, Dermatomyositis, Adult Type Must understand the risks and the benefits/purpose of the study and provide signed and dated informed consent Must be 18 years at time of signing the informed consent form Willing to participate in all required evaluations and procedures in the study including the ability to swallow pills without difficulty Patients must have a diagnosis of DM based upon the characteristic cutaneous findings proposed by Sontheimer[6] and/or a skin biopsy consistent with DM Patients must be candidate for systemic therapy for their DM skin disease defined by inadequate response to aggressive sun protection along with the use of potent topical corticosteroids and/or immunomodulators Patients with a diagnosis of dermatomyositis on steroid-sparing agent and/or systemic steroids (maximum dose of prednisone 1mg/Kg) and still having cutaneous disease activity of at least 5 on the CDASI scale If on immunosuppressive treatments and/or steroids, patients must be on stable doses for at least 4 weeks (28 days) Patients must undergo age appropriate cancer screening Females of childbearing potential (FCBP) must have a negative pregnancy test at screening (day 0 of the study and every month throughout the study). While on investigational product and for at least 28 days after taking the last dose of investigational product Increasing or changing dose of topical therapy within 14 days of study day 0 (including but not limited to topical corticosteroids, tacrolimus, pimecrolimus) Increasing or changing systemic steroids dosing within 28 days of study day 0 Increasing or changing dosing for concurrent therapy agents within 28 days or 5 half-lives of the biologic agent, whichever is longer, before study day 0: methotrexate, azathioprine, mycophenolate mofetil, hydroxychloroquine, dapsone, leflunomide, cyclosporine, biologic agents (anti-TNFs), IVIG, rituximab History of any clinically significant (as determined by the investigators) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major uncontrolled disease Any condition, including the presence of laboratory abnormalities, which places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Pregnant or breastfeeding Untreated Latent Mycobacterium tuberculosis infection or active tuberculosis infection as indicated by a positive Purified Protein Derivative (PPD) skin test or T-spot Any condition, including the presence of laboratory abnormalities that places the patient at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study Patients with acute dermatomyositis onset and rapid progression of muscle disease or significant systemic involvement including pulmonary diseases associated with DM Prior major surgery or major life-threatening medical illness within 2 weeks
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0
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