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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 Adult males and females between 18 and 49 years of age Females of child-bearing potential must have a negative serum beta-human choriogonadotropin (HCG) on Day -7 and agree to use an effective birth control method for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse, surgical sterilization). All female subjects will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator Agree to storage of blood, NP swab, and RNA specimens for future research Available for the duration of the study. Subjects must be willing and able to make follow-up visits as specified by the protocol Any contraindiciations for adults for the receipt of LAIV: --Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine,or life-threatening reactions to previous influenza vaccination Currently breast-feeding Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Clinically significant alanine aminotransferase (ALT) levels, as determined by one of the protocol investigators will be exclusionary at baseline, prior to vaccination Evidence of upper respiratory tract illness (URI) including fever, sore throat, and rhinorrhea. Enrollment of subjects with evidence of URI on Study Day -7 will be temporarily deferred Deviated nasal septum or nasal obstruction Body Mass Index greater than 35 NIH employee involved in direct patient care, consistent with the NIH CC policy that employees should avoid patient care for 5 days following receipt of LAIV. In addition, NIH employees must not be under the supervision of the study principal or associate investigators Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and cooperate with the study protocol Seropositive to the influenza A component viruses of seasonal LAIV (serum HAI titer of greater than or equal to 1:10) Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 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): 56.0-999.0, Meningitis Meningococcal Meningitis Meningococcal Infections Invasive Meningococcal Disease Aged 56 or older on the day of inclusion Informed consent form had been signed and dated Able to attend all scheduled visits and complied with all trial procedures Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) Participation at the time of 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 in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccines Previous vaccination against meningococcal disease with either a trial vaccine or another vaccine Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically At high risk for meningococcal infection during the trial Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines used in the trial or to a vaccine containing any of the same substances Personal history of Guillain-Barré syndrome
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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, Cervical Intraepithelial Neoplasia Cervical Cancer Vaginal Intraepithelial Neoplasia Vulvar Intraepithelial Neoplasia Persistent Infection Female subjects between, and including, 18 and 45 years of age at the first vaccination; 2. Healthy subjects as established by medical history and history-oriented clinical examination; 3. Be able to understand and comply with the request of the protocol; 4. Without acute cervicitis; 5. Not pregnant; 6. Have intact cervix Use of any investigational or non-registered product (drug or vaccine)within 30 days preceding the first vaccination, or plan to use during the study period; 2. Are using immunosuppressants; 3. Administration of immunoglobulin and/or any blood products within the three months preceding the first vaccination or planned administration during the study period; 4. Vaccinated of inactivated vaccine 14 days or attenuated vaccine 21 days before the enrollment; 5. Fever; 6. Concurrently participating another clinical trial; 7. Has received vaccines against HPV 16/18 ; 8. Immunodeficient; 9. History of allergic disease; 10. Serious medical disorders; 11. Blood coagulation disorders; 12. Epilepsy; 13. Unable to comply with protocol due to the mental illness; 14. Visible Condyloma; 15. Pregnant or breast-feeding women; 16. vergins; 17. Have more than 4 sexual partners
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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): 5.0-80.0, Cystic Fibrosis Patients with cystic fibrosis patients with cystic fibrosis who could not stay at the clinic for more than 4 hrs
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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): 18.0-35.0, Vestibulodynia non pregnant women between 18-35 naïve to HCs or other hormonal medications Patients able to provide Informed Consent and complete questionnaires Patient intends to use HCs for at least one year On exam before initiation of HCs, patient does not have primary PVD, pelvic floor hypertonicity, vaginismus or congenital abnormalities Patient will be available for follow up appointments Patient is willing to undergo gynecologic examination, if dyspareunia develops Patients with endocrine disturbances (including PCOS), liver diseases and eating disorders Patients who suffer from Hypertension, Migraine with aura or clotting disturbances Patients that experience pain with intercourse or tampon insertion Patients that have other contraindications for HCs use
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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, Family Satisfaction Healthcaregiver Satisfaction Family PTSD Family HADS Family Traumatic Dissociation patient : adult, 1 relative at minimum, mechanically ventilated at least 48 hours; and 2. family : french-speaking, adult Conflict, organ donor, refusal to participate
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Healthy Men and women aged over 18 years Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, ametropia < 6 Dpt Regular use of medication (except contraceptives), abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Treatment in the previous 3 weeks with any drug Symptoms of a clinically relevant illness in the 3 weeks before the first study day Patients with known hypersensitivity to the study drug or any ingredients History or current COPD or asthma AV-block grade II or more Ametropy ≥ 6 Dpt Pregnancy
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-60.0, Influenza Age greater than or equal to 18 years and less than or equal to 60 years 2. Body mass index (BMI) of 19-32 kg/m(2) 3. Estimated glomerular filtration rate greater than or equal to 90 mL/min at screening, calculated using the MDRD formula 4. Subjects must agree to Not take any prescription or OTC medications with the exception of Tylenol, vitamins, seasonal allergy medications, and/or contraceptive medications for a period 7 days prior and during study drug administration Not consume any alcohol for a period 2 days prior to and during study drug administration. 5. One of the following in order to avoid pregnancy Females who are able to become pregnant (i.e., are not postmenopausal) have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception From the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug. At least one of the methods of contraception should be a barrier method Males who have not undergone surgical sterilization and are sexually active with women must agree to use condoms plus have a partner use at least one additional effective form of contraception from the date of the subject s signing of the informed consent form through 28 days after the last dose of study drug Any chronic medical problem that requires daily oral medications (except Tylenol, oral contraceptives, vitamins, and seasonal allergy medications), or other medical history that in the opinion of the investigator significantly increases the risk associated with a phase I drug. 2. History of cardiovascular disease or unexplained syncope 3. Women who are breast-feeding. 4. Positive urine or serum pregnancy test. 5. Abnormal ECG -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table. --evaluating PR interval, QTc interval and rhythm. 6. Abnormal chemistry panel -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table --evaluating only sodium [Na], potassium [K], serum bicarbonate [total CO2], creatinine, glucose,albumin, ALT, AST, ALKP, GGT, total bilirubin, LDH, and estimated GFR by the MDRD equation. 7. Abnormal complete blood count (CBC) -defined as any clinically significant baseline Grade 1 or greater toxicity, or any Grade 3 or greater toxicity (regardless of clinical significance) by the toxicity table - evaluating only the WBC (to absolute neutrophil and lymphocyte counts), hemoglobin, hematocrit, and platelets. 8. Abnormal urinalysis -defined as any clinically significant baseline Grade 1 or greater toxicity --evaluating only protein, and RBCs. 9. Urine-albumin-to-creatinine ratio (UACR) >30 mg/g. 10. Positive serology for Hepatitis B surface antigen. 11. Positive serology for Hepatitis C. 12. Positive serology for HIV-1. 13. Positive urine drug screen. 14. Participation in a study with receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study drug administration (i.e., Day 0) 15. Donation of blood or blood products within 30 days or plasma within 2 weeks prior to study drug administration (i.e., Day 0) 16. Receipt of blood products within 2 months prior to study drug administration (i.e., Day 0) 17. Receipt of any vaccination within 30 days prior to study drug administration (i.e., Day 0) 18. Any acute or chronic condition that, in the opinion of the Investigator, would limit the subject s ability to complete and/or participate in this clinical study
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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): 20.0-50.0, Healthy Age: Between 20 to 50 years of age, inclusive Weight: Between 45 to 95 kg, within 17 of Body Mass Index Menstruation cycle between 21 to 35 without contraceptive Subject who agree contraception during the study Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin) History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease history or evidence of drug abuse A subject whose lab test results are as follows; Liver function test (AST, ALT, GGT, ALP, LDH, Total bilirubin) > 1.25 X upper limit of reference range A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg Presence or history of drug abuse or positive result in urine drug screening test Blood donation during 2 months or apheresis during 1 month before the study Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included) Use of alcohol over 21 units/weeks Smoker who smoke more than 10 cigarettes per day Participation in clinical trials of any drug within 60 days prior to the participation of the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-45.0, Healthy Women Woman aged over 18 and under 45 years Having given free and informed written consent Having regular cycles (defined by a constant interval between periods of 28 to 30 days) Having periods for a duration of 4 + / days Not using contraception or using oral oestroprogestative contraception Contraceptive IUD Metrorrhagia Pregnancy BMI under 18 kg / m² and above 30 kg / m² Presence of at least one of the following abnormalities in serum iron balance : Hemoglobin <11.5 g / dl, transferrin saturation under 15% or greater than 50%, serum ferritin under 15μg / l or greater than 150 µg / l Active smoking or quit within the last 6 months Drinking more than 20 g of alcohol per day Iron supplementation or blood transfusion within 12 months before Blood donation within 3 months before Stay in altitude> 1500 m in the previous month before
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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, Hepatocellular Cancer Histologically confirmed advanced HCC Barcelona Clinic Liver Cancer stage C or stage B if you cannot tolerate or failed TACE No cirrhosis or Child-Pugh A cirrhosis Measurable lesions All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 grade 1 or less Able to swallow and retain oral medication Prior systemic regimens for HCC Uncontrolled hypertension CLIP score > 3 ECOG PS > 1 Clinically apparent central nervous system metastases or carcinomatous meningitis Pregnant or breastfeeding Active or clinically significant cardiac disease Evidence or history of bleeding diathesis or coagulopathy Any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 2 or higher within 4 weeks of enrollment Presence of a non-healing wound, non-healing ulcer, or bone fracture
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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, Rabies Aged 18 to < 65 years on the day of Informed consent form has been signed and dated Able to attend all scheduled visits and comply with all trial procedures Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination and until at least 4 weeks after last vaccination) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination)or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination Previous vaccination against rabies (in pre or post-exposure regimen) with either the trial vaccine or another vaccine Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C At high risk for rabies exposure during the trial Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances as the vaccines used in the study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-35.0, Weight Loss Anovulation Amenorrhea Infertility BMI ≥ 30.0 kg/m*m Self-reported history of regular menstrual cycles, irregular menstrual cycles, or PCOS Absence of hormonal contraception, fertility therapy, or insulin-sensitizing medication in the three months prior to enrollment Pregnant, breastfeeding, or lactating Lack of one or both ovaries and/or uterus Previous diagnosis of bleeding disorder(s) or current use of blood thinners/anticoagulants Vegan or gluten free Soy or peanut allergy
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-64.0, Influenza Main 1. Provide written informed consent 2. Males or females aged 18-64 years, inclusive 3. Symptomatic presumptive influenza A or B infection defined as the presence of: 1. a fever of ≥38.0ºC (≥100.4 ºF) at the screening visit OR a history of fever within the 24 hours prior to the screening visit and has administered antipyretic(s) in the 6 hours prior to the screening visit AND 2. ≥1 moderate systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) AND 3. ≥1 moderate respiratory symptom (cough, sore throat and nasal congestion) 4. Onset of illness no more than 40 hours prior to randomization. Onset of illness is defined as the time, the first of any one of the following, occurred: 1. time when the subjects' temperature was measured as elevated (≥38.0°C (≥100.4ºF) OR 2. time when the subject first experienced at least one respiratory symptom (cough, sore throat and nasal congestion) OR 3. time when the subject first experienced at least one systemic symptom (headache, feeling feverish, body aches and pains, and fatigue) Main Use of antiviral treatment for influenza (e.g. zanamivir, oseltamivir, rimantadine, or amantadine) within 14 days prior to screening 2. Received live attenuated or trivalent inactivated influenza virus vaccine in the previous 3 weeks. 3. History or presence of clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis, or bronchiectasis) or asthma 4. History of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status (See Appendix A: ) within the past 12 months 5. Presence of an immune compromised status due to chronic illness, organ transplantation or use of daily systemic immunosuppressants 6. Presence of clinically significant signs of acute respiratory distress during screening 7. Current use of inhaled medications (nasal or oral) or anticipated use of inhaled medications (nasal or oral) at any time during the study. 8. Current or a history of acute or chronic renal impairment requiring hemodialysis and/or a known or calculated creatinine clearance (CLCR) of <60 mL/min 9. History or presence of any clinical condition or evidence of organ dysfunction on examination which, in the opinion of the investigator, may affect either the subject's ability to participate in the study or the study results
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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, Pruritus Patients w/ histologically confirmed mycosis fungoides stage IB to IVA eligible to receive oral vorinostat Patients w/ stage IB to IV reporting pruritus Patients age 18-85 years, of any race, sex, and ethnicity Life expectancy > 24 weeks Patient must have performance status of ≤2 on the ECOG Performance Scale Patients w/ a min. of 3 weeks since their last systemic treatment Women who are not pregnant, lactating, or of childbearing potential Female patients w/ reproductive potential must use an adequate contraceptive method during treatment and for three months after completing treatment Male patient w/ reproductive potential, agrees to use an adequate method of contraception for the duration of the study and for 30 days beyond the duration of study Patients, or legal representative must to be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study Patients w/ a recent cardiac history, such as a myocardial infarct within the last year, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities Patients w/ a history of liver damage (2.5 x normal ALT, AST), leukopenia, or thrombocytopenia Women who are pregnant or nursing a child Patients w/ severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen Patients who have received and histone deacetylase inhibitor within the last 6 months Patients receiving valproic acid will be excluded unless there has been a wash-out period of 30 or more days Patients who will have received systemic therapy, radiation therapy or phototherapy within 3 weeks prior to initial dosing with study drugs or who has not recovered from adverse events due to agents administered more than 3 weeks earlier QTc prolongation greater than 500ms Patient w/ a "currently active" second malignancy, other than non-melanoma skin cancer and carcinoma in situ of the cervix, should not be enrolled Patients are not considered to have a "currently active" malignancy if they have completed therapy for a prior malignancy, are disease free from prior malignancies for >5 years or are considered by their physician to be at less than 30% risk of relapse
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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): 18.0-89.0, Surgical Procedure Age 18 2. Diagnosed with a benign surgical pathology 3. Patient scheduled for elective minimally invasive gynecologic surgery Have a diagnosis of gynecologic cancer 2. History of prior laparoscopic surgery 3. Emergency surgery 4. Inability to provide informed consent 5. Unable to follow up in the office for post operative visits 6. Skin hypersensitivity or allergy to marker dye 7. Positive pregnancy test
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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, Contraceptive Methods Comparison women who desire contraception Women with large fibroids,abnormal uterine bleeding including heavy menstrual bleeding or using any contraceptive pills during the previous 3 months were excluded from the study. Other were pelvic inflammatory disease, pregnancy, genital tumor or thromboembolic disease
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-55.0, Healthy Volunteer Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination Japanese subjects must have Japanese parents and grandparents who were born in Japan Caucasian subjects must have Caucasian parents and grandparents Body mass index (BMI) 18 kg/m2 inclusive Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable) Smokes more than 5 cigarettes per day during the three months prior to study conduct Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening Positive test for drugs of abuse Any suspicion of or history of alcohol and/or other substance abuse or addiction Pregnant or lactating 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): 18.0-999.0, Contraception Women aged 18 and over Was pregnant within the last 10 weeks Interested in using the etonogestrel implant for contraception Willing to have investigators come to the home for an insertion visit Presenting to University Hospitals for delivery or contraception Has running water and a working bathroom in the home Has a safe and private location in the home for the implant to be inserted Current or history of thrombosis or thromboembolic disorders Liver tumors or active liver disease Undiagnosed abnormal genital bleeding Known or suspected breast cancer or history of breast cancer Allergic reaction to components (ethylene vinylacetate, etonogestrel, barium sulfate) of etonogestrel implant or local anesthetics Women currently taking hepatic enzyme inducers including but not exclusive to barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenylbutazone, phenytoin, rifampin, topiramate, protease inhibitors, and St. John's wort Uncontrolled hypertension Housing located greater than 10 miles from University Hospitals Center for Women's Health The location of the home is in a place that would not be safe for investigators Participant is homeless
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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): 18.0-99.0, Sinusitis Diagnosis of chronic rhinosinusitis years of age or older English speaking Pregnant or breastfeeding women vasculitis cystic fibrosis primary ciliary dyskinesia allergic fungal sinusitis gross immunodeficiency current use of chemotherapy insulin-dependent diabetes mellitus recent trial of maximal medical 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): 17.0-999.0, Cystic Fibrosis Diagnosis of Cystic Fibrosis based on genetic testing and/or sweat chloride levels Chronic infection with Pseudomonas aeruginosa Patients able to produce daily sputum samples Current history of at least two pulmonary infective exacerbations in the past 12 months Able to give written informed consent Unable to provide written informed consent Patients unable to produce daily sputum samples Fewer than two infective pulmonary exacerbations in 12 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): 18.0-79.0, Aging for older adults Healthy men and women 55 to 79 years of age Sedentary or minimally physically active for at least the prior 1 year Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years Premenopausal women will be eumenorrheic and will be studied during the early follicular phase (days 1 through 6) of the menstrual cycle Able to give consent. for young adults Healthy men and women 18 to 35 years of age Sedentary or minimally physically active for at least the prior 1 year Women will be premenopausal, eumenorrheic and will be studied during the early follicular phase (days 1 through 6) of the menstrual cycle Able to give consent history of diabetes history of any relevant cardiovascular diseases (myocardial infarction, angina pectoris, history of coronary artery bypass surgery or angioplasty, congestive heart failure, or arrhythmia) hypertension (≥160 mmHg systolic or ≥100 mmHg diastolic) history of renal impairment history of gout or hyperuricemia history of hepatic disease or infection with hepatitis B, C history of seizures, or other relevant on-going or recurrent illness recent (within 3 months) or recurrent hospitalizations use of tobacco products >5 % weight change in the prior 6 months
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Stage IA Non-Small Cell Lung Carcinoma Stage IB Non-Small Cell Lung Carcinoma Stage IIA Non-Small Cell Lung Carcinoma Stage IIB Non-Small Cell Lung Carcinoma Stage IIIA Non-Small Cell Lung Cancer Undergoing a diagnostic biopsy, including computed tomography (CT)-guided or bronchoscopic for suspected diagnosis of NSCLC Able to understand and sign an informed consent discussing the risks and benefits of obtaining a concurrent research biopsy; patients who have a fresh frozen biopsy available secondary to institutional tissue collection protocols may substitute such a biopsy for the study-required pre-treatment biopsy Histologically confirmed diagnosis of operable NSCLC that has not been previously treated Clinical stage IA-IIIA Appropriate candidate for surgical management, in the opinion of the treating thoracic surgeon Eastern Cooperative Oncology Group (ECOG) performance status =< 2 at the time of initiation of neoadjuvant epigenetic therapy Absolute neutrophil count > 1,000/mcL Platelets > 100,000/mcL Total bilirubin < 1.5 x institutional upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional ULN Patients who have received prior chemotherapy or radiation for their diagnosis of lung cancer Patients may not be receiving any other investigational agent History of allergic reactions attributed to compounds of similar chemical or biologic composition to entinostat or 5-azacytidine Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this protocol Any co-morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications Human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible Known or suspected hypersensitivity to azacitidine or mannitol Patients with advanced malignant hepatic tumors Use of anti-neoplastic or anti-tumor agents that are not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy, is not permitted while participating in this study; Note: study participants with stage II or III NSCLC, or stage I NSCLC with tumor size greater than 4 cm, should be offered standard adjuvant platinum-based chemotherapy in accordance with local practice (post-operatively)
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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): 0.75-1.417, Meningitis Meningococcal Infection Male and female subjects aged 9 to 17 months on the day of Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures Participation in the 4 weeks preceding or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for (i) influenza vaccination, which may be received at least 2 weeks before study vaccines (ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule (iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs) Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically At high risk, in the opinion of the Investigator, for meningococcal disease during the 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): 18.0-45.0, Obstetric Fistula Presentation to the Fistula Care Centre in Lilongwe for medical evaluation 2. Ability to consent for study participation in Chichewa 3. Female aged 18-45 years 4. Willingness to undergo pelvic ultrasound for assessment of pelvic organs No history of pregnancy 2. History of hysterectomy 3. Current pregnancy or pregnancy within the past six weeks 4. Seriously or terminally ill
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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, Breast Milk Production First time mothers between the ages of 18 and 45 who have had a vaginal or caesarean delivery and are feeling well First time mothers are used to avoid confounding variables due to previous positive or negative experiences from expressing milk. Their infant will have been born at less than 32.0 weeks of gestation Mothers will intend to breastfeed and are planning to pump milk on site in the NICU at least once/day and will be recruited 7-10 days postpartum Mothers who smoke, are taking medication that may interfere with breastfeeding, and who have undergone prior breast surgery will not be excluded since they are their own control With regard to language, mothers must be able to understand the directions and sign a consent form in English Mothers will not be recruited whose infant has a low likelihood of survival as determined by the attending physician Mothers who have been diagnosed with mastitis will not be recruited for 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): 18.0-60.0, Smoking Woman 18-60 Years Old smoking woman 18-60 years old not smoking Not want to participate in 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): 18.0-45.0, Contraception Healthy, Mexican female subjects requesting contraception Age >/=18 to </=45 years (inclusive); smokers must not be older than 30 years at the time of informed consent Normal or clinically insignificant cervical smear not requiring further follow-up; a cervical smear has to be taken at the screening visit, or a normal result has to be documented within the previous 6 months. Human papilloma virus (HPV) testing in subjects with atypical squamous cells of undetermined significance (ASCUS) can be used as an adjunctive test. Subjects with ASCUS can be included if they are negative for high-risk HPV strains Pregnancy or lactation (less than 6 months since delivery, abortion, or lactation before start of treatment) Body mass index (BMI) >30 kg/m2 Hypersensitivity to any ingredient in the study drug Any diseases or conditions that can compromise the function of body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results Any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator Undiagnosed abnormal genital bleeding Abuse of alcohol, drugs or medicine (eg, laxatives) Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug
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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): 4.0-30.0, Healthy elective tonsillectomy with or without adenotomy according to clinical indication age >4 and <30 years written informed consent from the study subject or his/her guardian Fluenz® will be used for ages >4 and <30 years, i.e. off-label use of ages >18 and <30 years systemic anti-inflammatory medication within prior 4 weeks systemic diseases affecting the immune system e.g. autoimmune diseases, immune complex diseases or immune deficiency diseases other than allergy, asthma or atopic dermatitis malignancy, depression, psychiatric illness or medication; planned vaccination during the study period (vaccinations should not be given during study period) forced expiratory volume in 1 second (FEV1) is under 80% of normal value or asthma is in a bad balance for those patients who would participate in the immunotherapy sublingual grass pollen will not be given for children under the age of 5 additional for Grazax® hypersensitivity to any of the excipients (gelatin [fish source], mannitol, sodium hydroxide), inflammatory conditions in the oral cavity with severe symptoms such as oral lichen planus with ulcerations or severe oral mycosis, patients with uncontrolled or severe asthma (in adults: FEV1 < 70% of predicted value after adequate pharmacologic treatment, in children: FEV1 < 80% of predicted value after adequate pharmacologic treatment) addition for Fluenz® hypersensitivity to the active substances, to any of the excipients (sucrose, dibasic potassium phosphate, monobasic potassium phosphate, gelatin [porcine, Type A], arginine hydrochloride, monosodium glutamate monohydrate, gentamicin [a possible trace residue], eggs or to egg proteins [e.g. ovalbumin] and children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-35.0, Oligomenorrhea Amenorrhea Polycystic Ovary Syndrome (PCOS) Between 18 and 35 years BMI ≥ 18 kg/m2 If ≥ 21 years old, must have had healthy pelvic exam w/in past 2 years Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>36 days) with or without a previous diagnosis of PCOS from a primary care provider Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity Pregnant or breastfeeding Not otherwise healthy
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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, Polycystic Ovary Syndrome (PCOS) Menstrual Irregularity Between 18 and 48 years BMI ≥ 18 kg/m2 Either Regular menstrual cycles (21-35 days) Irregular menstrual cycles (>36 days); or Previous diagnosis of PCOS from a primary care provider If 21 years of age or older, must have had a healthy pelvic exam w/in the past 2 years Current use of medication(s) known or suspected to interfere with reproductive function (eg. oral contraceptives) or insulin sensitivity Pregnant or breastfeeding Not otherwise healthy Significant weight changes within the last three months
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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): 18.0-55.0, Healthy Volunteer Healthy male and female volunteers, 18 to 55 years of age inclusive. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination Body mass index (BMI) between 18 to 32 kg/m2 inclusive Nonsmoking subjects and former smoking subjects (who have not smoked for the past six months before first dosing) Female subjects must be surgically sterile or postmenopausal for the past year Male subjects and their partners of childbearing potential must be willing to use two effective methods of contraception, one of which must be a barrier method (e.g., condom) during the study and for 90 days after the last drug administration Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating Positive urine test for drugs of abuse, alcohol, or cotinine test at screening or prior to admission to the study unit Suspicion of regular consumption of drug(s) of abuse including marijuana Current smokers or subjects who have discontinued smoking less than six months prior to first dosing History (within three months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol). Alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study (including the washout period) until discharge Positive for hepatitis B, hepatitis C, or HIV infection Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to first dosing Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, absorption, distribution, metabolism or excretion of study medication, or that would, in the opinion of the PI, pose an unacceptable risk to the subject in this study History of hypersensitivity to any of the additives in the RO5424802 formulation (lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, hydroxypropyl cellulose, sodium lauryl sulphate, magnesium stearate) Any history of hypersensitivity to or contraindication to the use of rifampin or other rifamycins or history of severe drug-related allergic reactions or hepatoxicity
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, HIV Drug Use History of current or former injection drug use No clinic visits with an HIV provider in the preceding 12 months Not taking ART HIV RNA level of greater than 1,000 copies/mL Agree to attend at least one HIV care visit at the Johns Hopkins Moore clinic Any medical or psychiatric condition that would interfere with the participant's ability to comply with study procedures or make participation unsafe Current enrollment in another HIV retention-in-care 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): 19.0-64.0, Influenza Provide written informed consent prior to initiation of any study procedures Are able to understand and comply with planned study procedures and be available for all study visits Are males or non-pregnant females, 19 to 64 years old, inclusive Are in good health, as determined by vital signs (oral temperature, pulse, and blood pressure), medical history, and targeted physical examination based on medical history to ensure any existing medical diagnoses or conditions (except those in the Subject ) are stable . Subjects may be on chronic1 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. Note: Topical, nasal, and inhaled medications (with the exception of steroids as outlined in the Subjects (see Section 5.2), vitamins, and contraceptives are permitted Oral temperature is less than 100.4 degrees F Pulse is 50 to 115 bpm, inclusive Systolic blood pressure is 85 to 150 mm Hg, inclusive Diastolic blood pressure is 55 to 95 mmHg, inclusive Erythrocyte sedimentation rate (ESR) is less than 30 mm per hour Alanine aminotransferase (ALT) is less than 44 IU/L for females or is less than 61 IU/L for males Creatinine is less than 1.11 mg/dL for females or is less than 1.38 mg/dL for males White blood cells (WBC) are greater than 3.9 x10^3/UL and less than 10.6 x10^3/UL
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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): 18.0-50.0, Influenza 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 breast feeding and 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 greater 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. Prechallenge serum hemagglutination inhibition (HAI) titer against the challenge virus of greater than or equal to 1:40 or less than or equal to 1:10 during a screening visit in protocol #11-I-0183 7. HIV uninfected. 1. 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., diabetes mellitus, renal dysfunction, hemoglobinopathies). 4. Immunosuppression or ongoing malignancy. 5. Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures). 6. Postinfectious or postvaccine 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 greater 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 metabolic disease (e.g., diabetes mellitus, renal dysfunction, hemoglobinopathies) Immunosuppression or cancer Neurological and neurodevelopmental conditions (e.g., cerebral palsy, epilepsy, stroke, seizures) Individuals who are receiving long-term aspirin therapy Women who are pregnant or who are trying to become pregnant. 3. Individual with body mass index (BMI) less than or equal to 18.5 and greater than or equal to 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. Neutropenia below 1,500 cells/mm(3) (Grade 2 or greater) 8. Urinalysis outside of the NIH DLM normal reference range and deemed clinically significant by the PI. 9. Clinically significant abnormality on electrocardiogram. 10. Clinically significant abnormality as deemed by the PI on echocardiographic testing. 11. Clinically significant abnormality as deemed by the PI on the Pulmonary Function Test (PFT). 12. Recent acute illness within 1 week of admission to the isolation facility. 13. Known allergy to treatments for influenza (including but not limited to oseltamivir, nonsteroidals). 14. Known allergy to 2 or more classes of antibiotics (e.g., penicillins, cephalosporins, fluoroquinolones, or glycopeptides). 15. Receipt of blood or blood products (including immunoglobulins) within 3 months prior to enrollment. 16. Receipt of any unlicensed drug within 3 months or 5.5 half-lives (whichever is greater) prior to enrollment. 17. Receipt of any non-influenza related unlicensed vaccine within 6 months prior to enrollment. 18. 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 tetrahydrocannabinol (THC) or metabolites). 19. Self-reported or known history of psychiatric or psychological issues deemed by the PI to be a contraindication to protocol participation 20. Known close contact with anyone known to have influenza in the past 7 days. 21. Any condition or event 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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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-39.0, Healthy Women 18-39 years of age who are in good health Good general health as a result of review of medical history and/or clinical testing at the time of screening Available for the duration of the trial Willingness to participate in the study as evidenced by signing the informed consent document Willing to be abstinent or to use non-hormonal methods of contraception for the duration of the study History of normal menstrual cycles (26-35 days in length) for at least 3 months Willingness to refrain from routine vaccination (except as administered during study) for the duration of the study Use of contraceptive pills, patch, injection or other hormonal therapies in the preceding 3 months (6 months for DepoProvera) A history of hypersensitivity, including anaphylaxis to any of the components of IIV or to eggs Previous receipt of a same season licensed influenza vaccine Pregnancy as determined by a positive urine or serum human choriogonadotropin (β-hCG) test at any point during the study or in the preceding 3 months Currently is lactating or breast-feeding Fewer than 3 normal menstrual cycles since conclusion of last pregnancy or last use of hormonal birth control A history of autoimmune disease, or any other chronic medical condition considered clinically significant by the investigator History of HIV, Hepatitis C or active Hepatitis B Known immunodeficiency syndrome History of Guillain-Barré 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): 0.0-0.333, Healthy Healthy newborn infant Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation) Age of infant is between 14 days at the time of enrollment Birth weight between 2500g and 4500g For the Formula fed groups: The infant's mother has elected, before the 14th day of their child's life, not to continue breastfeeding (no breastfeeding after the 14th day of the child's life) For the Breastfed group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age Having obtained his/her legal representative's informed consent Congenital illness or malformation that may affect normal growth Significant pre-natal and/or post-natal disease Re-hospitalization for more than 2 days in the first 14 days of life. (Exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study) Newborn who have received antibiotics during the first 14 days of life Receiving infant formula containing pro and/or prebiotics at the time of enrolment Newborn whose parents / caregivers cannot be expected to comply with treatment Newborn currently participating in another 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): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed
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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): 7.0-999.0, Type 1 Diabetes Type 2 Diabetes for A subject is eligible for the user evaluation study if all of the following are met: 1. Subject is 7 years or older at time of screening 2. Subject is current insulin pump user for at least 3 months 3. Subject has the following CGM experience as determined by the Investigator Has experience and is able to insert/change sensor by herself/himself and Has experience and can recharge the transmitter and Has experience and can read sensor data in real-time on her/his pump screen 4. Subject/legal representative has signed a Patient Informed Consent and is willing to comply with the study procedures; 5. Subject is willing to complete study questionnaires throughout the study 6. Must have the following clinical diagnosis: 1. Type 1 diabetes, for a minimum of 6 months prior to enrollment for A subject is excluded from the user evaluation if any of the following are met: 1. Female subject has a positive urine pregnancy screening test. 2. Female subject who plans to become pregnant during the course of study. If a woman becomes pregnant during participation, she will be withdrawn 3. Subject has any condition that, in the opinion of the Investigator or qualified Investigational Centre staff, may preclude him/her from participating in the study and completing study related procedures. 4. Subject has impaired vision or hearing problems that could compromise the handling of the device as determined by Investigator or qualified Investigational Centre staff 5. Subject is unable to tolerate tape adhesive in the area of sensor placement 6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection) 7. Subject has travel plans which would make it difficult for the subject to attend on-site study visits as scheduled 8. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks (CEP267 User Evaluation is not included in this
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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, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship)
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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, Thyroid Cancer Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment
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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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months
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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, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL
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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 A Virus, H7N9 Subtype Adult males and non-pregnant females between 18 years and 49 years of age, inclusive. Children will not be recruited or enrolled in this study because they are not in the apparent risk group, and for safety considerations and because of the need for isolation General good health, without significant medical illness, physical examination findings, or significant laboratory abnormalities as determined by the investigator Agree to storage of blood specimens for future research Available for the duration of the trial Willingness to participate in the study as evidenced by signing the informed consent document Female participants of child-bearing potential must agree to use effective birth control methods for the duration of the study (for example, pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; intrauterine device; abstinence from heterosexual intercourse; surgical sterilization). All female participants will be considered being of child-bearing potential except those who have undergone hysterectomy and those in whom menopause occurred at least 1 year prior to the study Pregnancy, as determined by a positive human choriogonadotropin (beta-HCG) test Currently breastfeeding Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urine testing. Alanine aminotransferase (ALT) levels greater than two times the upper normal limit will be exclusionary at baseline, prior to vaccination Behavioral or cognitive impairment or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol Previous enrollment in an H7 influenza vaccine trial or in any study of an avian influenza vaccine Seropositive to the H7N9 influenza A virus (serum HAI titer greater than 1:8) Positive urine drug toxicology test indicating narcotic use/dependency Have medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol History of anaphylaxis
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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): 18.0-54.0, Placenta Previa Participant age 18 years or older Gestational age between 22w0d and 32w0d, inclusive, at time of enrollment Singleton pregnancy Complete Placenta Previa Intact Membranes No allergies to material in pessary Plan to deliver at PI's hospital Informed consent obtained, signed/dated Active preterm labor Nonreassuring fetal heart rate tracing Intrauterine fetal death Active bleeding (may be enrolled if hemostatic >48 hours) Ruptured membranes Any fetal condition likely to cause serious neonatal morbidity independent of gestational age: Fetal malformation likely to require surgery, Fetal malformation involving vital organs, Fetal viral infection, Hydrops fetalis Known Uterine Anomaly Cervical Cerclage present at time of enrollment Maternal condition that warrant continued hospitalization (example severe preeclampsia, Diabetes out of control, maternal heart disease)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.0-999.0, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Healthy Subject Age ≥ 18 years. Children will not be recruited into this study because children do not develop head and neck cancer. 2. Both males and females are eligible. 3. Members of all racial and ethnic groups are eligible. 4. Smoking and non-smoking people are eligible. The tobacco use assessment form must be completed following consent and registration (Appendix B). 5. No current or former diagnosis of cancer, with the exception of: excised and cured non-melanoma skin cancer; or carcinoma in situ of the cervix 6. No use of chronic prescribed medications which are potent inducers or inhibitors of CYP3A4 (Appendix A) 7. No chronic anticoagulation 8. No chronic use of steroids 9. Karnofsky Performance Scale ≥90% (Appendix C) 10. Able to provide written, informed consent 11. For women of child-bearing potential (WOCBP), a negative urine pregnancy test must be documented within 7 days prior to the first study intervention 12. No history of food intolerance to broccoli or pineapple and lime juices 13. Willing to avoid cruciferous vegetables during the study interventions (Appendix D) 14. Willing to avoid grapefruit or grapefruit juice 48 hours prior to or during the study 15. Willing to avoid daily vitamins and anti-inflammatory medications prior to and during the study 16. Potential effects of Broccoli sprout extract on the developing human fetus: The effects of Broccoli Sprout Extract on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation Failure to meet the above
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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): 20.0-35.0, PCOS women with PCOS according to the Rotterdam age 20-35 years not to have received any induction of ovulation in the preceding 3 months before enrollment contraindications to metformin prior surgical management of PCOS
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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, Family Member Be between the ages of 18 and 55 Live independently without medical assistance Willing to provide informed consent to participate in the study Willing to follow our procedures and requirements for the study, including: 1. providing blood, urine, and saliva samples 2. completing other assessments Patients may take a similar dietary supplement as the one used in the study, but they must stop taking all similar dietary supplements 2 weeks prior to starting the study and for the 6 weeks duration of the study Patients need to be free of major medical conditions, such as neurological, cardiovascular, pulmonary, renal, endocrine, thyroid, hepatic, autoimmune, or bone/joint disorders or conditions; psychiatric diagnoses or psychotic disorders, and have no gastrointestinal disorders that could affect how the dietary supplement is absorbed by their body Cannot participate in another similar research trial within 30 days of participating in this study Cannot be a smoker or have stopped smoking less than 6 months ago Cannot currently be taking any chemotherapy or radiation treatment for cancer Cannot be diagnosed with a terminal illness Cannot be diagnosed with insulin-dependent diabetes and/or be taking metformin Cannot be HIV positive If female, the patient cannot currently be pregnant, breastfeeding, or intending to become pregnant within the next month
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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, To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB Adult females aged 18-45 Free and willing to fully comply with treatment process Healthy women seeking LARC Married or in a steady relationship (at least 1 year) Blood hemoglobin >11.5gr/dL Signed informed consent form If took COCP at least had one cycle after use of OC Use IUB/IUD as an emergency contraception A previously placed IUD that has not been removed Pregnancy or suspicion of pregnancy Immediately post-abortion or post-partum unless had at least one free cycle Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap) History of pelvic inflammatory disease, recent or remote Postpartum endometritis or postabortal endometritis in the past 3 month Mucupurulent cervicitis Endometrial thickness more than 12 mm on insertion date
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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): 25.0-42.0, Reversible Prevention of Pregnancy * Adult females aged 25-42 Free and willing to fully comply with treatment process Healthy women seeking LARC Married or in a steady relationship (at least 1 year) Blood hemoglobin >11.5gr% Signed informed consent form If took COCP at least had one cycle after use of OC (major) Use IUB/IUD as an emergency contraception A previously placed IUD that has not been removed Pregnancy or suspicion of pregnancy Use of other contraception method (condom for either male or female, oral contraceptives, diaphragms, spermicides, hormonal patches, injections or ring, cervical cap) History of pelvic inflammatory disease, recent or remote Postpartum endometritis or post abortal endometritis in the past 3 month Mucopurulent cervicitis Endometrial thickness more than 12 mm on insertion date Known anemia
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2
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 0.5-2.0, Respiratory Syncytial Virus Infections Participant is at least 6 months but less than 25 months of age at the time of inoculation Parent or guardian who demonstrates their understanding of the study, signs the informed consent, and agrees to vaccine administration following detailed explanation of the study Seronegative for RSV antibody, defined as a serum RSV neutralizing antibody titer less than 1:40 as determined within 42 days prior to inoculation Participant's history has been reviewed and participant has undergone a physical examination indicating that s/he is in good health. Permitted concomitant medications nutritional supplements, medications for gastroesophageal reflux, eye drops, and topical medications, including topical steroids, topical antibiotics, and topical antifungal agents Participant has received routine immunizations appropriate for age, administered: 1. at least 2 weeks prior to study vaccine inoculation (inactivated and subunit vaccines and rotavirus vaccine) OR 2. at least 4 weeks prior to study vaccine inoculation (all other live vaccines) Participant is expected to be available for the duration of the study Known or suspected impairment of immunological functions, including maternal history of positive HIV test Receipt of immunosuppressive therapy including systemic corticosteroids within the past 30 days. NOTE: Topical steroids, topical antibiotics, and topical antifungal medications are acceptable Bone marrow/solid organ transplant recipient Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders Previous immunization with an RSV vaccine Previous serious vaccine-associated AE or any anaphylactic reaction Known hypersensitivity to any vaccine component Lung or heart disease, including any wheezing event or reactive airway disease. NOTE: Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who had one episode of wheezing or received bronchodilator therapy for a single episode of illness in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may be enrolled Member of a household that contains an immunocompromised individual Member of a household that contains infants less than 6 months of age
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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, Respiratory Viral Illnesses: Influenza A/B, RSV, Adenovirus Sample from patients exhibiting signs/symptoms of respiratory viral infection All medical standard-of-care testing requested by the submitting clinician is complete and has been reported to the clinician/requestor Samples that are incorrectly de-identified
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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, Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Laryngeal Verrucous Carcinoma Recurrent Lip and Oral Cavity Squamous Cell Carcinoma Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary Recurrent Oral Cavity Verrucous Carcinoma Recurrent Oropharyngeal Squamous Cell Carcinoma Tongue Carcinoma Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 Histologically confirmed recurrent squamous cell carcinoma of the oral cavity, pharynx, (oropharynx, larynx) and neck Tumor accessible for unrestricted illumination for interstitial photodynamic therapy (PDT) (accessibility as determined by the physician) Patients on chemotherapy &/or targeted agents for palliation Life expectancy of at least 6 months in the judgment of the physician Subjects of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 6 months after the last treatment; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Subject or legal representative must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure Radiotherapy within the last 2 months in the area to be treated Patients with known brain metastases should be excluded from this clinical trial Tumor invading a major blood vessel (such as the carotid artery) Tumor is not clearly shown on a computed tomography (CT) scan Location and extension of the tumor precludes an effective I-PDT Patients with porphyria, or with known hypersensitivity to porphyrins or porphyrin-like compounds While blood cell (WBC) < 2.0 x 10^9/L Total serum bilirubin > 2.0 mg/dl Serum creatinine > 2 mg/dl Alkaline phosphatase (hepatic) > 3 times the upper normal limit
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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): 19.0-75.0, Post Traumatic Stress Disorder Diagnosis of PTSD Iraq or Afghanistan female Veteran Psychiatry stability (no suicide, homicide) One clear memory of a trauma Stability on psychiatric medications for 1 month Active substance use/abuse (or in remission less than 3 mo) Psychotic symptoms or diagnosis Bipolar disorder diagnosis Cognitive impairment Involvement in a violent relationship Self mutilation within past 6 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): 18.0-55.0, Healthy Volunteer Healthy male and female participants. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, and a complete physical examination Body mass index between 18 to 32 kilograms per meter-squared (kg/m^2) inclusive Non-smoking participants and former smoking participants who have not smoked for the past 6 months before first study drug dosing Female participants must be surgically sterile or postmenopausal for the past year Male participants and their partners of childbearing potential must be willing to use two effective methods of contraception, one of which must be a barrier method (for example, condom) during the study and for 90 days after the last drug administration Willing to abstain from xanthine-containing beverages and food (coffee, tea, cola, chocolate, and "energy drinks") from 72 hours prior to Day -1 through study end Willing to abstain from grapefruit-, pomelo-, star fruit-, or Seville orange-containing products from day 7 prior study start until study end Willing to avoid prolonged sun exposure while taking alectinib and through follow-up Women of childbearing potential, pregnant or lactating women, or males with female partners who are pregnant or lactating Clinically significant abnormalities on physical examination, vital signs, or laboratory test results during screening or prior to admission to the study center Positive test for drugs of abuse, alcohol, or cotinine at screening or prior to admission to the study center or suspicion of regular consumption of drug(s) of abuse including marijuana History (within 3 months of Screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams [g] of alcohol). Alcohol consuming will be prohibited from 72 hours prior to study start until the end of the study Participants with any risk factors or family history for QT/Fridericia's corrected QT interval (QTcF) prolongation or electrocardiogram abnormalities A history of any concurrent clinically significant hematologic, renal, hepatic, pulmonary, neurological, psychiatric, allergies, gastrointestinal, metabolic or endocrine disorder, or cardiovascular disease or infections Positive screening test for hepatitis B, C, or human immunodeficiency virus (HIV) Use of any medications (prescriptions or over-the-counter), within 2 weeks or 5 half-lives (whichever is longer) before the first dose of study drug with exception of acetaminophen up to 2 g per day up to 48 hours prior to dosing, not to exceed 4 g total during the week prior to dosing Routine or chronic use of more than 2 g of acetaminophen daily Use of any herbal supplements (for example, St. John's Wort) or any metabolic inducers within 4 weeks or 5 half-lives (whichever is longer) before the first dose of study drug, including but not limited to the following drugs: rifampin, rifabutin, glucocorticoids, carbamazepine, phenytoin, and phenobarbital
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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, Tinnitus years of age History of chronic subjective tinnitus that cannot be attributed to vascular, neurologic, neoplastic or traumatic causes Capable of self-applying the lidocaine patches History of heart disease History of irregular heartbeat Prior MI Previous exposure to lidocaine as a treatment for tinnitus An allergy to adhesives Allergy to lidocaine Taking medications, herbal remedies and supplements that may interact with lidocaine, including but not limited to antivirals, benzodiazepines, and St. John's Wart Known liver disease Known kidney disease Adults who do not speak English
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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, Infection For Initial VSTs and subsequent infusions: patients will be eligible following any type of allogeneic transplant if they have CMV, adenovirus, EBV, BK virus and/or HHV6 infection/disease persistent or recurrent despite 14 days of standard therapy OR after failure of treatment after 7 days of standard therapy OR if unable to tolerate standard therapy. Patients with persistent JC virus infection will be eligible as well. 1. Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood. 2. Treatment of the following persistent or relapsed infections despite standard therapy; 1. CMV: Treatment of persistent or relapsed CMV disease or infection after standard therapy. For CMV infection, standard therapy is defined as antiviral therapy with ganciclovir, foscarnet or cidofovir CMV disease: defined as the demonstration of CMV by biopsy specimen from visceral sites (by culture or histology) or the detection of CMV by culture or direct fluorescent antibody stain in broncheoalveolar lavage fluid in the presence of new or changing pulmonary infiltrates or changes consistent with CMV retinitis on ophthalmologic examination CMV infection: defined as the presence of CMV positivity as detected by PCR or pp65 antigenemia or culture from ONE site such as stool or blood or urine or nasopharynx Failure of antiviral therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or pp65 antigenemia after 7 days of antiviral therapy. 2. Adenovirus: Treatment of persistent adenovirus infection or disease despite standard therapy. Standard therapy is defined as antiviral therapy with cidofovir or an alternative antiviral agent if patient will not tolerate cidofovir therapy because of poor renal function Adenovirus infection: defined as the presence of adenoviral positivity as detected by PCR or culture from ONE site such as stool or blood or urine or nasopharynx Adenovirus disease: defined as the presence of adenoviral positivity as detected by PCR, DFA or culture from two or more sites such as stool or blood or urine or nasopharynx Failure of therapy: defined as a rise or a fall of less than 50% in viral load in peripheral blood or any site of disease as measured by PCR or any other quantitative assay) after 7 days of antiviral therapy. 3. EBV: For treatment of persistent EBV infection despite standard therapy. For EBV infection, standard therapy is defined as rituximab given at 375mg/m2 in patients for 1-4 doses with a CD20+ve tumor EBV infection: defined as Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR,Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood Failure of therapy is defined as: Increase or less than 50% response at sites of disease for EBV lymphoma OR, Increase or a fall of less than 50% in EBV viral load in peripheral blood or any site of disease after 1st dose of rituximab. 4. BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide. No clear standard treatment is defined. Cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy. In small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine Patients receiving ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment. 2. Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 3. Patients who are less than 28 days removed from their allogeneic hematopoieteic stem cell transplant or who have received donor lymphocyte infusions (DLI) within 28 days. 4. Patients with active acute GVHD grades II-IV. 5. Active and uncontrolled relapse of malignancy
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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, Colitis, Ulcerative The trial population consists of adult subjects of both sexes with active ulcerative colitis aged 18 to 75 years. The main comprise Fully capable to give informed consent Mentally able to understand the nature, significance, implications and risks of the clinical trial and to follow instructions of the trial staff Written informed consent Clinical Mayo Score of ≥3 Total Mayo Score of ≥6 Endoscopic Mayo score ≥2 in the sigmoid Body mass index ≥18.0 to ≤29.0kg/m2 and body weight ≥50 to ≤100kg Negative urine pregnancy test (female subject only) Using two methods of contraception Colectomy and presence of ileal pouch-anal anastomosis or ileorectal anastomosis Diagnosis of ulcerative proctitis, fulminant colitis, toxic megacolon, of colitis indeterminata or Crohn's disease Ileostoma Anti-TNFα treatment with adalimumab, certolizumab, etanercept, golimumab, or infliximab ≤4 weeks prior to screening visit Change in systemic glucocorticoid treatment ≤1 weeks prior to screening visit Change in 5-Aminosalicylic Acid (ASA) therapy ≤1 week prior to screening visit Start of treatment with an immunosuppressive agent ≤3 months prior to screening visit Change in treatment with an immunosuppressive agent ≤4 weeks prior to baseline visit Planned concomitant therapeutic administration of suppositories or foams or enema other than the IMP Impaired blood coagulation (Quick value <50% and/or partial thromboplastin time (PTT) >55sec and/or platelet count <50.000/μl.)
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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, End Stage Renal Disease Male or female subject aged 18 years at Screening; 2. Eligible female subjects of childbearing potential with a non-sterilized male sexual partner must agree to use 2 medically accepted, effective methods of birth control (eg, hormonal contraceptive, barrier contraceptive with additional spermicide, or an intrauterine device) beginning >30 days prior to study drug administration and continuing until 7 days after the end of the study. Female subjects who are postmenopausal must have been postmenopausal for >1 year if they wish not to use contraceptives. If postmenopausal status is questionable, the subject's follicle stimulating hormone level must be checked and must be elevated and consistent with postmenopausal levels (ie, >40 IU/L); otherwise these subjects must agree to use contraceptives listed above; 3. Male subjects with sexual partners of childbearing potential must agree to use a barrier contraceptive from the time of study drug administration through 7 days after the end of the study; 4. Female subjects of childbearing potential (including females with questionable postmenopausal status) must have a negative pregnancy test prior to dosing (Screening and Day -1); 5. Has a body mass index of 17 kg/m2 to 40 kg/m2, inclusive; 6. Has negative alcohol and illicit drug screens; 7. Has a negative screen for Human Immunodeficiency Virus; 8. Is able to understand and comply with study procedures and give written informed consent according to institutional and regulatory guidelines; Subjects with ESRD renal impairment: 9. Has a positive diagnosis of ESRD maintained on hemodialysis treatments 3 times a week for at least 3 months with a minimum Kt/V of 1.2; 10. Is otherwise considered healthy except for abnormalities consistent with underlying ESRD as determined by past medical history, physical examination, vital signs, and laboratory tests at Screening; Healthy subjects without renal impairment: 11. Must be in good health as determined by screening medical history, physical examination, vital signs, blood chemistry, hematology, glucose, and coagulation performance at Screening; 12. Has a negative screen for hepatitis B (HBV) and hepatitis C (HCV); and 13. Should be matched to a subject with renal impairment in gender, age, and BMI Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the course of the study; 2. Has a history or current evidence of clinically significant hematological, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, neurological, or psychiatric disease that may pose a significant safety risk or diminish a subject's ability to undergo all study procedures and assessments; 3. Use of another investigational drug or device within 30 days prior to receiving eravacycline (TP-434), or within at least 5 half-lives of the previous investigational drug, whichever is longer; 4. Has a history of alcoholism or drug abuse within 6 months prior to dosing; 5. Has urinary incontinence; 6. Has a typical weekly alcohol consumption of 14 alcoholic drinks. One drink is defined as 1 glass of beer (approximately 10 oz to 12 oz) or 1 can (12 oz) of beer, 1 glass of wine (approximately 4 oz to 5 oz), or 1 glass of distilled spirits (hard liquor) containing 1 oz of the liquor (1 oz of liquid is approximately 30 mL); 7. Use of alcohol within 48 hours prior to admission until completion of the final PK draw on Day 5; 8. Has had a major surgical procedure within 3 months prior to administration of study drug; 9. Has known allergies to tetracycline antibiotics or related compounds, or a history of multiple adverse drug allergies of any origin; 10. Has inadequate venous access; 11. Donated >500 mL of blood within 2 months prior to Screening; 12. Is a member of the clinical site personnel directly affiliated with this study; 13. Has poor mental function or any other reason to expect subject difficulty in complying with the requirements of the study in the judgment of the investigator; 14. Has any surgical or medical condition which might significantly alter the absorption, distribution, or excretion of the drug; 15. Fails to comply with protocol requirements, or whose further participation in the study would be unsuitable to the subject, as determined by the investigator; 16. Clinically significant abnormal electrocardiograms (ECGs) (QTcF >500 msec); 17. Has clinically significant abnormal laboratory value(s), other than those consistent with stage 5 chronic kidney disease. Aspartate aminotransferase or alanine aminotransferase >1.5 × the upper limit of the reference range or total bilirubin >1.5 × the upper limit of the reference range. A single repeat is allowed for determination; 18. Unwillingness to refrain from liquids or food containing grapefruit, cranberry, caffeine, or other xanthines from 96 hours prior to admission until completion of the final PK draw on Day 5; 19. Unwillingness to refrain from eating foods containing poppy seeds for 48 hours before admission until completion of the final PK draw on Day 5; 20. Unwillingness to abstain from any unaccustomed strenuous exercise or contact sports for at least 72 hours prior to the Screening Visit and 72 hours prior to admission on Day -1 until discharge from the study; Subjects with ESRD renal impairment: 21. Has active HCV or HBV and is receiving antiviral therapy (either prescribed or herbal); 22. Has fluctuating or rapidly deteriorating renal function as indicated by clinical and/or laboratory signs of renal impairment; 23. Has signs of active infection; 24. Takes any herbal concomitant medication within 7 days, or 5 half-lives (if known), whichever is longer, prior to dosing and within 24 hours after dosing, excluding hormonal contraceptives; Subjects without renal impairment: 25. Has systolic blood pressure outside of the range of 90-160 mmHg, or diastolic blood pressure outside the range of 45-100 mmHg, or heart rate outside the range of 50 100 bpm for female subjects or 45-100 bpm for male subjects; 26. Has a history of Gilbert's disease; or 27. Takes any concomitant medication, either prescribed or over the counter. This includes any prescription or non-prescription medication, including vitamins or herbal medications, within 7 days, or 5 half-lives (if known), whichever is longer, prior to dosing and within 24 hours after dosing, excluding hormonal contraceptives. The use of acetaminophen, naproxen, and ibuprofen is permitted except for within 24 hours prior to dosing
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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, Metabolism Exercise Subjects will be male or female, 18 yr -45yr and free from any known or suspected chronic conditions. General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise. Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion. During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese". Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
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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, Metabolism Subjects will be male or female yr -45yr and free from any known or suspected chronic conditions General health and suitability to participate in an exercise/health research study will be confirmed through use of the PAR-Q+ screening questionnaire Any participant who has a positive answer to a screening question will be required to seek physician approval prior to any physical exercise Baseline arrhythmia (tachycardia (>100pbm) and systolic or diastolic hypertension (>140/90 mmHg) will also be reason for exclusion During baseline anthropometric assessment we will confirm that participants all fall within a typical BMI range (20-30 kg/m2) of either "normal" weight or "overweight", but not "underweight" or "obese" Persons who take cardiovascular medications, metabolic medications, smoke cigarettes, excessively consume alcohol, are prone to heartburn, or have a previous diagnosis of hyperlipidemia or hyperinsulemia will also be excluded
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 12.0-55.0, Minor Recurrent Aphthous Stomatitis Lesions a history of minor recurrent aphthous stomatitis (RAS) lesions occurring at least 3-4 time/ year, and usually requiring 5 or more days to resolve presence of an active ulcer of less than 48 hours duration on either the buccal or labial mucosa (making them more easily accessible for powder application) willing and able to give informed consent pregnant or lactating if ulcers were manifestations of a systemic disease process such as ulcerative colitis, Crohn's disease, Behcet's syndrome, or anemia concurrent clinical conditions that could either pose a health risk to the patient by being involved in the study or potentially influence the outcome of the study hypersensitivity to dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, karaya gum, or zinc oxide having used corticosteroids, oral retinoids, or other immunomodulatory agents within one month of participation in the study; non-steroidal anti-inflammatory agents (e.g., aspirin, ibuprofen, etc.), acetaminophen, or oral antihistamines chronically within one month of participation in the study or any use within five days of participation in the study; topical medication (including steroids, retinoids, and anti-microbial drugs) within two weeks of participation in the study, systemic antibiotics within two weeks of participation in the study; any preparation or medication (OTC or prescription) applied to the ulcer within 48 hours of participation in the study history of drug or alcohol abuse having had any dental work within 2 weeks of study entry having had any orthodontic or oral appliances (that could cause oral trauma) within 1 cm of the ulcer or any recollection of trauma in the area of the ulcer participating in any other study involving investigational or marketed products within 1 month of study entry or plans to participate in such an investigation during this study
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-40.0, Tubal Patency i. Women between 18 and 40 years old ii. In good health, with regular menstrual cycles that occur 24 days iii. No current use of hormonal contraception or an intrauterine device and having had at least one complete menstrual cycle since having stopped hormonal contraception before starting the treatment. iv. Have a negative urine pregnancy test at the admission visit. v. Have a negative chlamydia test at the admission visit. vi. Not be at risk for pregnancy. They will be consistently using a non-hormonal contraception method, have a surgically sterile male partner with a vasectomy, be abstinent, or be in a same-sex relationship from the screening visit through the first study cycle. After starting the combined OC (see Visit 4 below), use of a non-hormonal method is no longer required. vii. In the opinion of the investigator, willing and able to follow all study requirements, including use of the approved study medications (doxycycline, oral contraceptive and DMPA). viii. Understand and sign an IRB approved inform consent form prior to screening activities. ix. Will have diastolic blood pressure (BP) ≤85 mm Hg and systolic BP ≤145 mm Hg after 5 minutes in sitting position. x. Agree not to participate in any other clinical trials during the course of this study i. Women with menstrual cycle length of less than 24 or more than 37 days; or with spontaneous irregular menstrual cycle length with intra-individual variations of more than 5 days ii. Currently pregnant as confirmed by positive high-sensitivity urine pregnancy test iii. Women planning pregnancy within their months of study participation iv. Currently breast-feeding or within 30 days of discontinuing breast feeding v. Current use of a hormonal IUD, or other hormonal contraception (including oral contraceptives, contraceptive vaginal rings, contraceptive patches, or contraceptive implants) within 30 days prior to screening. NOTE: Discontinuation of hormonal contraception or removal of implanted hormonal contraceptives must have been for personal reasons unrelated to the purpose of enrollment in this study. vi. Undiagnosed abnormal genital bleeding vii. Known hypersensitivity to radio-opaque contrast, doxycycline, levonorgestrel, ethinyl estradiol or depo-medroxyprogesterone acetate. The active ingredients in the approved medications used in the study. viii. Anomalies in the clinical exam or history done at screening visit recognized as clinically significant by the investigator. ix. Unable to pass a uterine sound at the screening examination. x. A positive test for chlamydia at screening, or a history of a positive test within the last 6 months. xi. A clinically significant Pap test abnormality, as managed by current local or national guidelines that would require treatment over the next 6 months. xii. Invasive cancer (past history of any carcinoma or sarcoma, except non-melanoma skin cancer) xiii. Body mass index (BMI) >35. xiv. Current use of a non-hormone containing (copper) intrauterine device (IUD). NOTE: Removal of an IUD must have been for personal reasons unrelated to the purpose of enrollment in this study. xv. Smoking if > age 35. xvi. Personal history of venous or arterial thrombosis or embolism, or family history in a first-degree relative <55 years of age suggesting familial defect in blood coagulation system, which in the opinion of the principal investigator, suggests use of a hormonal contraceptive could pose a significant risk. xvii. Cerebrovascular or cardiovascular disease. xviii. History of retinal vascular lesions, unexplained partial or complete loss of vision. xix. Headaches with focal neurological symptoms. xx. History of cholestatic jaundice of pregnancy or jaundice with prior steroid use. xxi. Use of liver enzyme inducers on a regular basis. xxii. History of involuntary infertility, pelvic inflammatory disease (not followed by a normal pregnancy), or known gynecologic conditions or surgery that could affect tubal patency (e.g. tubal adhesions, endometriosis, hydrosalpinx, salpingectomy, hysterectomy, oophorectomy). xxiii. History of a prior HSG showing tubal occlusion on one or both sides
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-42.0, Pregnancy less than 29 weeks pregnant ages 18-42 planning to deliver at The Ohio State University Wexner Medical Center prior serious adverse reaction to seasonal influenza vaccine
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-40.0, Influenza Healthy individuals aged 18-40 years. 2. Able to understand and give informed consent. 3. Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 30 days before and 30 days after TIV vaccination You received blood product within 3 months of enrolling in the study or a live attenuated vaccine within 4 weeks or inactivated vaccines within 2 weeks You received the 2014-2015 flu vaccine or had a confirmed case of influenza during 2014-2015 You received any antibiotics 6 months prior to enrolling in the study or expect to take antibiotics one month after vaccination You received probiotics or prebiotics 3 months prior before enrolling in the study or expect to take one month after vaccination You received proton pump inhibitors, H2 blocker receptors, or antacids 3 months regularly before enrolling in the study or one month after You had an allergic response or sensitivity to past vaccinations You have health conditions that weaken your body's ability to fight infections or you are taking drugs like steroids that weaken your body's ability to fight infections.(Some nasal and topical steroids are allowed.) You have a chronic medical problem including (but not limited to) insulin dependent diabetes, severe heart disease including arrhythmias, severe lung disease, auto immune diseases and or grade 4 uncontrolled hypertension Chronic neurological conditions such as seizure disorder, Parkinson disease, myasthenia gravis, neuropathy, or histories of encephalopathy, meningitis or ototoxicity Any history of gastrointestinal disease, kidney or liver diseases
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 35.0-50.0, Bone Health Osteoporosis participants had not been engaged in resistance training or in Yoga exercise for at least 12 months prior to the study did not have chronic back or joint problems or cardiovascular disease not taking antihypertensive drugs or any medication that affects bone density not taking hormonal contraception they self-reported having regular menstrual cycles body weight more than 300 pounds
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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): 21.0-50.0, Healthy Healthy males/females Age range from 21 to 50 years and be within 20% of their normal weight (Broca-Index) All female volunteers must use a safe contraception (i.e. oral contraceptives, intrauterine devices; sterilised) and must have a negative urine pregnancy test All subjects must have a negative hepatitis B, C and HIV tests as well as a negative drug screening Prior to admission to the treatment after giving his/her informed consent (in accordance with Good Clinical Practice and local legislation) in writing, each subject will have his/her medical history taken and will receive a complete medical examination (incl. blood pressure and pulse rate measurements) as well as 12-lead ECG within 14 days before the first administration of the test drug. Haematopoietic, hepatic and renal function tests will be carried out in the laboratory. The subject will fast for 12 hours before collection of specimens for all laboratory parameters Currently non-smoking (smoke free for >= one year and <=5 pack year smoking history) Normal spirometry as evidenced by a baseline FEV1 >= 90% of predicted normal value for age, height and sex Predicted normal values will be calculated according to European Community for Steel and Coal (ECCS) Ability to adequately use an inhalation aerosol device Ability to perform technically satisfactory pulmonary function tests Volunteers will be excluded from the study if the results of the medical examination or laboratory test (especially serum glutamate oxaloacetate transaminase (SGOT) > 2-fold of upper normal range, serum glutamate pyruvate transaminase (SGPT) > 1.5 - fold of upper normal range) are judged by the investigator to differ significantly from normal clinical values Volunteers who have an eosinophil count >= 600/mm³. A repeat eosinophil count will not be conducted in these subjects Volunteers with a serum potassium value >+ outside the normal range Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic immunological or hormonal disorders Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders Volunteers with known history of orthostatic hypotension, fainting spells or blackouts Volunteers with chronic or relevant acute infections Volunteers with upper respiratory tract infection in the past six weeks prior to the screening visit or between the screening visit and first test day Volunteers with a history of asthma or allergic rhinitis
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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, Bacterial Vaginosis For BV Subjects: (140 subjects) Premenopausal women over the age of 18 who have BV who are willing to sign informed consent Positive for all Amsel Vaginal pH > 4.5 Positive amine test > 20% clue cells on wet mount Grayish-white adherent discharge Subject is willing to refrain from using any vaginal medications, douches or spermicides except for the metronidazole suppositories that are given to her for the duration of the study Subject is willing to use supplied non-lubricated condoms when sexually active. But not to have sexual intercourse within 48 hours of any Study Visit Subject to refrain from alcohol for 24 hours prior to the first 7 days of the metronidazole treatment and for 48 hours after completion of this treatment. for Healthy control group Study for BV Study Subjects Mixed vaginal infection at time of enrollment Pregnancy, nursing or planning on getting pregnant Subject on anticoagulation therapy, lithium therapy or Antabuse therapy Vaginal bleeding at time of enrollment Allergy to metronidazole Use of any vaginal antibiotics or antifungals in the previous 10 days, from enrollment Must not require treatment for an abnormal Pap smear or genital cancer Must abstain from vaginal douching during enrolled period. Study for Control Subjects
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 16.0-999.0, Hepatitis E Healthy people aged over 16 years old at the time of the first vaccination, normal intelligence and agree to sign the informed consent form Healthy subjects as established by medical history and history-oriented clinical examination before entering into the study Subjects will reside in the study region in the next 7 months Free of history of hepatitis E Can comply with the request of study Axillary temperature is below 37 degree centigrade For dose 1 receiving other vaccine or immunoglobulin within two weeks Having serious allergic history to vaccine and medicine Eclampsia, epilepsy, encephalopathy and history of mental disease or family Thrombocytopenia or other disturbance of blood coagulation which would lead to muscle injection taboo Fixed or suspected deficiency of immunologic function, containing immunosuppressant treatment, genetic defect, HIV or other factors Congenital malformation, eccyliosis or severe chronic disease Fixed or suspected other disease including fever, active infection, liver and kidney disease, angiocardiopathy, malignancy, acute and chronic disease joining other clinical study undergoing women pregnant or in lactation. For dose 2 or 3
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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, Lactation Women between the ages of 18 and 45 years Good general health Lactating Singleton birth Two to twelve weeks postpartum Have a full term (>37 weeks gestation) healthy infant Is successfully fully breastfeeding at the time they enter the study Intend to fully breastfeed their infants for the following 4 weeks at the time of enrollment Chronic illnesses (e.g. diabetes, hypertension, bronchial asthma, Gastroesophageal Reflux Disease (GERD), atopic dermatitis, celiac disease or gluten sensitivity, Crohn's Disease, ulcerative colitis, eating disorders, breast cancer, blood disorder, psychiatric) Pre-pregnant BMI (>50) History of alcohol, drug abuse or cigarette smoking Currently using the following pharmaceuticals: diuretics, pseudoephedrine, anticholinergics, and an estrogen-containing birth control pill or using an estrogen-containing device Currently consuming other drugs/herbals used to induce milk production including metoclopramide, domperidone, or other drugs/herbals (i.e. fenugreek capsules, goat's rue products, or "More Milk" capsules or tinctures) Sensitivity or known allergies to peanuts, soybeans, or chick peas Sensitivity or known allergies to plants in the Apiaceae/carrot plant family (e.g. anise, celery, coriander, fennel) or the compound anethole Sensitivity or known allergies to plants in the Asteraceae/daisy family (e.g. blessed thistle, echinacea, or calendula) Taking a selective serotonin reuptake inhibitor (SSRI)
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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): 75.0-999.0, Influenza Immunization Older Adults Over Age 75 Adults over age 75 years Allergies to egg or vaccine Active malignancies On radiation or chemotherapy Active systemic inflammatory diseases including rheumatoid arthritis, Crohn's disease, and ulcerative colitis Acute exacerbation of chronic cardiopulmonary conditions including decompensated CHF or COPD Taking oral steroids (such as prednisone) or immune modulating drugs (such as methotrexate) Lacking the capacity to consent (individuals who do not understand what Flu shot is or need someone else to decide if s/he should get the Flu shot)
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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): 20.0-999.0, Endometriosis Female, 20 years of age and older 2. Weight between 40kg~70kg 3. Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing 4. A history of regular menstrual cycles (cycle: 28±7day, duration: 2~7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of IP(investigational product) dosing Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding 2. A history of breast cancer, genital cancer or any estrogen dependent tumor 3. Specified or unspecified diagnosed infertility or history of natural abortion over three times 4. A history of taking other Investigational product within 60days before screening visit or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter drugs) within 14days before screening visit 5. Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia 6. AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal 7. QTc > 450ms on electrocardiogram result
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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, Squamous Cell Carcinoma of Skin Carcinoma, Squamous Cell Must have histologically or cytologically confirmed squamous cell carcinoma of the skin. Potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. Similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible Must have measurable disease, defined by Response according to Response Evaluation in Solid Tumors (RECIST) v1.1 as at least one lesion that can be accurately measured in at least one dimension of >10 mm by CT, MRI, or calipers There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. Prior topical treatment with 5-fluorouracil is permitted. Patients who are on chronic daily doses of prednisone of greater than 10 mg are excluded. There is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 21 days have passed since last administration Life expectancy of greater than 3 months Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60% Must have normal organ and marrow function Must not be candidates for curative locoregional treatments. Patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent document Have had chemotherapy or radiotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier May not be receiving any other investigational agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to either 5-FU/Capecitabine or Interferon Uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements Women who are pregnant or breastfeeding Any heart or lung transplant patient on immunosuppressive agents. Renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis. Patients with Chronic Lymphocytic Leukemia (CLL) or other hematologic malignancies are allowed as long as they meet other listed above
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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 Signed informed consent prior to any study-mandated procedure Japanese or Caucasian. (Japanese subjects: both parents of the subject are Japanese [born in Japan]. Caucasian subjects: both parents of the subject are Caucasian) Body mass index between 18 and 28 kg/m^2, inclusive Women not of childbearing potential Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to drug intake on Day 1; use a reliable method of contraception and continue this contraception for the duration of the study and for at least 2 months after study drug intake. In addition, her partner must use a condom Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and heart rate (HR) 50-95 beats per minute (inclusive) lead electrocardiogram without clinically relevant abnormalities at screening Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening Negative results from urine drug screen at screening Ability to communicate well with the Investigator (if necessary with the help of an interpreter) and to understand and comply with the requirements of the study Electrocardiograph PQ/PR interval (time interval from the beginning of the P wave to the beginning of the QRS complex) > 200 milliseconds at screening Nursing woman History of asthma or chronic obstructive pulmonary disease Known hypersensitivity to any excipients of the drug formulation Treatment with another investigational drug within 3 months prior to screening Excessive caffeine consumption, defined as > 800 mg per day at screening History or clinical evidence of any disease and/or existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism or excretion of the study drug Any cardiac condition or illness, including ECG abnormalities, with a potential to increase the cardiac risk of the subject Smoking within the last month prior to screening Any immunosuppressive treatment within 6 weeks before study drug administration
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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, Immediate Postpartum Hemorrhage The trial will women aged 18 years or older who have just had a vaginal delivery between 35 and 42 weeks of gestation with a PPH persisting 15 minutes after the injection of 5 UI or 10 IU of oxytocin by slow IV and uterine massage and who provided informed written consent. If her condition does not allow her consent to be obtained immediately in ethically acceptable conditions, it may be obtained from her healthcare agent, or if there is none, from a family member, if present. In case where neither a healthcare agent nor a family member is present on the day of the patient can nonetheless be included. She will be informed secondarily, and her consent will be requested for the potential continuation of the research and use of her data Patient beneficiary or affiliated to a health insurance The trial will not women who have just had a cesarean delivery with a contraindication to Sulprostone with clinical chorioamnionitis or an in utero fetal death or a medically-indicated termination of pregnancy with PPH secondary to cervicovaginal lacerations without any uterine hemorrhage, uterine rupture, or placenta accreta with arterial bleeding requiring embolization with a purulent infection of the cervix, vagina or uterus with symptoms indicating a hysterectomy with cervical cancer
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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): 20.0-65.0, Healthy Healthy males and females Aged between 20 and 65 years old BMI in the normal range (18.5 to 25.0 kg/m2) Having signed his/her consent form Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine) Medically diagnosed anemia based on a blood formula Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis) Smokers (anamnesis) Pregnancy (anamnesis) Under corticoids or hormone (adrenal, thyroid) treatment Alcohol intake: > 2 units a day (anamnesis) Consumption of illicit drugs (anamnesis) Having given blood within the last month, or willing to make a blood donation until one month following the end of the study Subject who cannot be expected to comply with the study procedures, including consuming the test product
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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): 20.0-45.0, Meal Timing Are 20-45 years of age Have a weight between 150 and 220 lbs Have a body mass index between 25 and 35 kg/m2 inclusive (a number calculated from your height and weight) If you are a female, have a regular menstrual cycle that is between 25 and 35 days long If you are female, had your period within the last 35 days Regularly go to sleep between 9:30 pm and 12:00 am Regularly eat dinner 9 or more hours after eating breakfast Are willing to have about 2/3 cup of your blood stored for future research related to this study Have diabetes or are on anti-diabetes medication Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease Have stomach or intestinal problems Regularly use medications such as steroids, beta blockers, adrenergic-stimulating agents, and laxatives Take any medications or supplements known to affect sleep, circadian rhythms, or metabolism (with the exception that certain forms of birth control are allowed) Have abnormal lab work that is clinically significant in the opinion of the study physician Are pregnant or lactating Take the Depo Provera shot, or use an Interuterine Device (IUD) or hormone patch for birth control If you are on hormonal birth control, have been on a stable dose for less than 3 months Have smoked or used nicotine/tobacco products within the last 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): 0.0-99.0, PI3KCD CTLA4 STAT3GOF MAGT1 The following apply to all subjects Patient and relatives aged 0-99 years old to women who are pregnant or breastfeeding. Only patients >2 years of age, in stable clinical status and meeting the weight requirement of the NIH CC will be physically evaluated at the NIH CC Willingness to allow storage of blood, saliva, and other tissue specimens for future use in medical research Willingness to participate in genetic testing and allow sharing of genetic information in secure databases like dbGAP. These tests may but are not limited to, whole exome and whole genome sequencing Priority may be given to individuals with a family history (if readily available) suggestive of multiple affected members with a constellation of signs and symptoms suggestive of immune dysfunction among first or second-degree relatives of special populations A. NIH employees are eligible B. Women who are pregnant or breast feeding are eligible to enroll as probands Pregnant relatives are also eligible for as they can provide important controls, genetic reference and historic clinical information. This protocol is not actively seeking women who are pregnant. --C. Pediatric populations are eligible, with restrictions, in order to learn about the natural history of the immune disorders under investigation and to provide diagnostic work up for their ongoing clinical care. Healthy pediatric relatives can provide important diagnostic and genetic reference for affected patients. -Pediatric populations are eligible, with restrictions, in order to learn about the natural history of the immune disorders under investigation and to provide diagnostic work up for their ongoing clinical care. Healthy pediatric relatives can provide important diagnostic and genetic reference for affected patients. Patients must have An identified genetic basis for an immune disorder or signs and symptoms suggestive of clinically significant immune dysregulation and/or immunodeficiency manifesting with features including but not limited to autoimmunity, autoinflammatory conditions, lymphadenopathy, end-organ dysfunction, unusual infections, allergies, or laboratory abnormalities consistent with immune dysregulation Patients will be excluded for any of the following Known genetic disorders that are already well characterized, such as severe combined immunodeficiency (SCID), chronic granulomatous disease (CGD), etc., and those in which we do not have an enduring research interest in the LCIM Patients with unknown immune disorders will be excluded if they have received chemotherapy within the last 6 months for a malignancy or have infections such as HIV or mycobacterial infections Severe clinical illness requiring highly specialized teams and institutions. The NIH may not be able to provide appropriate care for certain referred cases. The Principal Investigator (PI) may determine that the patient is eligible for enrollment but ineligible for admission to the Clinical Center. Patients and relatives with certain obstetric issues may pose a safety risk for travel and evaluation here. for this group will be determined on a case by case basis by the PI Patients with well-defined autoimmune conditions such as systemic lupus erythematosus (SLE), Hashimoto s thyroiditis, Addison s disease, Graves disease, sarcoidosis and rheumatoid arthritis, among others. Blood relatives will be excluded for the following: -Any condition which in the opinion of the investigator may interfere with evaluation of an immune system abnormality that is the subject of study under this protocol
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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): 0.083-999.0, Pulmonary Arterial Hypertension of Congenital Heart Disease The patient has a congenital heart disease other than patent foramen ovale The diagnosis of pulmonary hypertension was confirmed by cardiac catheterization. Only patients with Eisenmenger syndrome can be included without catheterization The catheterization was done after 1 January 2009 A mean pulmonary artery pressure > 25 mm Hg Pulmonary vascular resistances > 3 piece Wood m2 Pulmonary capillary pressure available Consent for in the study must be signed by parents or legal guardians for minors, by the patient for adults The patient he had a surgical procedure or interventional catheterization cardiac catheterization between his diagnosis and in the observatory? If yes, it can only be included if a new catheterization confirmed the persistence of HTAP at least 6 months after the procedure Patient follow-up (at least once a year) in the center for its HTAP associated with congenital heart disease its
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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, Recurrent Melanoma Stage IV Melanoma Signed written informed consent Histologically confirmed diagnosis of metastatic melanoma with the presence of the B-Raf proto-oncogene, serine/threonine kinase (BRAFV600) mutation Eastern Cooperative Oncology Group (ECOG) performance status < 3 Absolute neutrophil count (ANC) >= 1.0 x 10^9/L Hemoglobin (Hgb) >= 9 g/dL without transfusions Platelets (PLT) >= 90 x 10^9/L without transfusions Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN); patient with liver metastases =< 5 x ULN Total bilirubin =< 2 x ULN, or < 5 ULN if Gilbert’s disease Creatinine =< 1.5 mg/dL, or calculated creatinine clearance (determined as per Cockcroft-Gault) >= 50 mL/min Left ventricular ejection fraction (LVEF) >= 50% as determined by a multigated acquisition (MUGA) scan or echocardiogram (ECHO) Prior exposure to BRAF or MEK inhibitors Any active central nervous system (CNS) lesion (i.e., those with radiographically unstable, symptomatic lesions) and/or leptomeningeal metastases; however, patient treated with stereotactic radiotherapy, whole brain radiation or surgery are eligible if patient remained without evidence of CNS disease progression >= 4 weeks; patients must be off corticosteroid therapy for >= 2 weeks History or current evidence of retinal vein occlusion (RVO) or predisposing factors to RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) History of retinal degenerative disease History of Gilbert’s syndrome Previous or concurrent malignancy is not an provided that the other malignancy is considered under control and target lesions from melanoma are clearly defined for response assessment Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) < 6 months prior to screening Symptomatic chronic heart failure, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality < 6 months prior to screening except atrial fibrillation and paroxysmal supraventricular tachycardia Uncontrolled arterial hypertension despite medical treatment
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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, Food Selection healthy non-smoking BMI of 18-27 non-dieting typically consumes breakfast/lunch distaste for eggs vegetarian current smoker restrained eating habits recent weight change history of significant disease of past medical history pregnant lactating irregular menstrual cycle
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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): 21.0-75.0, Stage 0 Breast Carcinoma Breast Neoplasms Stage I Breast Carcinoma Stage II Breast Carcinoma Stage III Breast Carcinoma History of histologically-confirmed stage 0, I, II, or III breast carcinoma without evidence of disease at trial entry. Participants with a resected local recurrence are eligible Minimum of 6 months since last chemotherapy, biologic therapy (i.e., trastuzumab), radiation therapy, and/or breast surgery and no evidence of recurrent disease Minimum of 6 months since completion of adjuvant tamoxifen (tamoxifen is known to lower mammographic density119-121). Current use of a third generation aromatase inhibitor [AI] (i.e., anastrozole, letrozole, exemestane) is permitted provided that the participant has been on a stable dose for the past 6 months Age 21 to 75 years. Both pre and postmenopausal women will be included in this study. We will perimenopausal women, defined as menstrual cycle irregularity (variable cycle length that differs from normal by more than 7 days) and an Follicle-Stimulating Hormone (FSH) greater than 20 mili international units Negative serum pregnancy testing Normal mammogram of the contralateral breast within the past 12 months, defined as no new suspicious calcifications or other abnormal findings warranting a breast biopsy Eastern Cooperative Oncology Group (ECOG) performance status less than 2 Participants must have normal organ and marrow function within 28 days prior to randomization Body mass index (BMI) greater than or equal to 25 kilograms per meter squared or baseline fasting glucose of less than 126 milligrams per deciliter History of histologically-confirmed bilateral breast cancer History of or plans for bilateral mastectomies Evidence of metastatic breast cancer Prior radiation therapy or implant in the contralateral breast Known diabetes (type 1 or 2) or baseline fasting glucose greater than 126 milligrams per deciliter Any condition associated with increased risk of metformin-associated lactic acidosis (e.g., congestive heart failure defined as New York Heart Association [NYHA] Class III or IV functional status, history of acidosis of any type, intake of 3 or more alcoholic beverages per day on average over the past 6 months) Currently taking metformin, sulfonylureas, thiazolidinediones, or insulin for any reason History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or omega-3 fatty acids Receiving hormone replacement therapy, tamoxifen, or raloxifene within 6 months of trial entry Participants may not be receiving any other investigational agents for 30 days prior to baseline evaluation and during the study intervention
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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): 0.0-0.019, Healthy Healthy newborn infant Full term infant (= 37 weeks gestation; = 42 weeks gestation) Birth weight = 2500 g and < 4200 g Singleton birth Infant is = 7 days of age at the time of enrollment For the BF group: The infant's mother has elected to exclusively breastfeed her baby, from enrollment to 4 months of age For the FF groups: The infant's mother has elected to exclusively formula feed her baby, from enrollment to 4 months of age Having obtained his/her or his/her legal representative's consent Newborn whose mother's BMI was normal (<20 or = 25) at start of pregnancy Newborn whose mother had developed gestational diabetes during pregnancy Newborn whose mother has diabetes of type-1 or type-2 Newborn whose mother smoked > 5 cigarettes / day during pregnancy Newborn whose mother had a drug dependence during pregnancy Newborn whose mother has a chronic infectious disease Newborn whose parents / caregivers cannot be expected to comply with treatment Newborn currently participating in another 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): 18.0-65.0, Spinal Cord Injury Spinal Cord Injured Between the ages of 18-65 years old Level of injury is between C1-T12 Primarily wheelchair dependent for ambulation Have a spinal cord injury that is ASIA Impairment Scale (AIS) grade of A, B or C Injury occurred more than 1 year ago Low blood pressure (Systolic BP less than 110 mmHg for males, Systolic BP less than 100 mmHg for females) Primary language is English I am right handed Currently have an illness or infection Severe history of AD (more than 3 symptomatic events per week, evidence of blood pressure elevations above 140/90 mmHg,significant adverse subjective symptoms reporting) Hypertension or diabetes History of Traumatic Brain Injury (TBI) Neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.) History of epilepsy or other seizure disorder Diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder Within the past 6 months, abused illicit drugs Pre-screen mini mental status exam score of less than 24, as rated by the researcher Vision is impaired
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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): 21.0-65.0, Alcohol Dependence Experienced binge drinking episode(s) (5 or more standard drinks for men and 4 or more standard drinks for women consumed in about 2 hours according to NIAAA definition) in the past 30 days DSM-IV diagnosed alcohol dependence, other drug dependencies including nicotine dependence
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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, HIV/AIDS and Infections Hepatitis B core antibody (anti-HBc) and anti-HBs negative 2. Age ≥18 years 3. HIV infected persons (HAART naïve and HAART exposed). HAART enrollees will be considered to be HAART exposed if they have been taking these medications for at least 3 months. Participants that have never been on HAART and those that have been on HAART for <3months will be considered to be HAART naïve. HAART exposed enrollees will have an adherence of at least 95%. 4. Ambulatory 5. Intention to attend the Mulago HIV/AIDS clinic for the 18 months 6. Able and willing to comply with study protocol including providing informed consent History of hypersensitivity to vaccines or intolerance to any of the HBV vaccine components 2. Previously-confirmed diagnosis of decompensated liver disease or HCC 3. Serological evidence of prior receipt of the HBV vaccine (anti-HBS positive, anti-HBc negative) or documented (clinical) evidence of having been vaccinated. 4. Known history of HBV infection (HBsAg and/or anti-HBc positive). 5. Inability to follow study procedures 6. If a participant chooses not to consent to the review of his or her medical records
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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, Obstetric Labor Complications Stillbirth Maternal Death All women in labour delivering at the study site and their outcome, October 2014 - January 2015 and October 2015 January 2016 All health care providers at the department during the baseline and intervention period, October 2014 January 2016 For the different substudies, sub-groups are selected (please see the secondary outcomes for a description)
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0
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A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
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eligible ages (years): 18.0-999.0, Healthy Subject is considered a healthy volunteer 2. Subject is male or female, over 18 years of age 3. Subject is informed and has been given ample time and opportunity to think about his/her participation and has given his/her written informed consent 4. Subject agrees to have blood drawn (venipuncture) and finger stick Subject is unable to give informed consent 2. Subject is less than 18 years of age 3. Female subject is pregnant 4. Subject is on anticoagulant medication or other medication known to affect PT/INR assessment (e.g., warfarin, heparin) for a minimum of 28 days before enrolling in the trial 5. Subject has a medical condition known to affect PT/INR (e.g. vitamin K deficiency, disseminated intravascular coagulation, liver disease, decreased or defective factor I, II, V, VII, or X) 6. Subject has already taken part in 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): 18.0-999.0, Glioblastoma [criteria apply to all cohorts unless otherwise specified]: 1. Cohort A: Subjects with newly diagnosed, untreated, unmethylated MGMT GBM who are eligible for standard radiation therapy. 2. Cohorts B, B2, B3 and C: First or second recurrence of GBM by diagnostic biopsy or contrast enhanced magnetic resonance imaging (MRI) per modified Response Assessment in Neuro-oncology (RANO) with last baseline MRI confirmation within 14 days prior to Study Day 1. Note: Recurrence is defined as progression following therapy (i.e., chemotherapy; radiation). If the subject had a surgical resection for relapsed disease and no anti-tumor therapy was administered for up to 12 weeks, and the subject has further evidence of tumor growth or undergoes another resection, this will be considered as one episode of recurrence. 3. Cohorts B, B2, B3 and C: On Study Day 1, at least 12 weeks from prior radiotherapy (unless progressive disease outside of the radiation field or histopathologic confirmation of unequivocal tumor). 4. Cohorts B, B2, B3: No prior vascular endothelial growth factor (VEGF)/VEGF receptor targeted therapy; Cohort C: No more than one prior bevacizumab regimen. 5. Cohorts B, B2, B3 and C: Recovery from any prior treatment clinically significant, related adverse events to grade ≤ 1 or pretreatment baseline with the exception of alopecia and laboratory values listed per criteria. 6. Subjects with measurable or non-measurable disease. 7. Histopathologic confirmation of glioblastoma. 8. At the time of Study Day 1, subjects must be at least 4 weeks since major surgical procedure, open biopsy, or significant traumatic injury; there should be no anticipation of need for major surgical procedure during the course of the study. There should be no core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Study Day 1. 9. Subjects who have previously been treated with the Optune™ device are eligible for the study as long as toxicity related to the treatment has resolved to ≤ grade 1 or baseline. 10. Eastern Cooperative Oncology Group (ECOG) ≤ 1 or Karnofsky performance status of ≥ 70. 11. Adequate hematologic, renal and hepatic function, as defined below Absolute neutrophil count ≥ 1000/mm^3 Platelet count ≥ 100,000/mm^3 Total bilirubin ≤ 1.5 x upper limit of normal (ULN); or if subject has Gilbert syndrome, then total bilirubin ≤ 3 x ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 x ULN Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 50 mL/min (using the Cockcroft-Gault formula) Female CrCl = (140 age in years) x weight in kg x 0.85/72 x serum creatinine in mg/dL Male CrCl = (140 age in years) x weight in kg x 1.00/72 x serum creatinine in mg/dL [criteria apply to all cohorts unless otherwise specified]: 1. Primary tumors localized to the brain stem or spinal cord. 2. Locally directed therapies including but not limited to stereotactic radiosurgery, re-irradiation, Gliadel®, and therapeutics administered by direct injection or convection-enhanced delivery within 6 months of start of study treatment. 3. Prior exposure to durvalumab or other programmed cell death-1 (PD-1), programmed cell death ligand-1 (PD-L1), cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies. 4. Presence of diffuse leptomeningeal disease or extracranial disease. 5. Active, suspected or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, irritable bowel syndrome, Wegner's granulomatosis and Hashimoto's thyroiditis). Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 6. Known primary immunodeficiency or active human immunodeficiency virus. 7. Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months indicated by positive test for hepatitis B virus surface antigen or hepatitis C virus ribonucleic acid (hepatitis C virus antibody). 8. History of organ transplant requiring use of immunosuppressive medication. 9. History of active tuberculosis. 10. Significant active systemic illness including infections requiring intravenous antibiotics. 11. Current pneumonitis or interstitial lung disease. 12. Other invasive malignancy within 2 years prior to entry into the study, except for those treated with surgical therapy only. 13. History of severe allergic reactions to any unknown allergens or any components of the study drugs. 14. Any prior grade ≥ 3 immune-related adverse event (irAE) or any prior corticosteroid-refractory irAE. 15. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study. 16. Lack of availability for follow-up assessments. 17. Lack of availability for Post Study Follow-up contacts to determine relapse and survival. 18. Women who are breast-feeding or pregnant as evidenced by positive serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin). 19. Women of childbearing potential not using a medically acceptable means of contraception for the duration of the study and unsterilized males not willing to abide by protocol-specified requirements for contraception. 20. If a subject previously received another investigational treatment, the last dose of investigational treatment was administered within 4 weeks of Day 1 of the study. 21. Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk. 22. Cohorts B2, B3, and C Evidence of hemorrhage on the baseline MRI or computed tomography (CT) scan other than those that are ≤ grade 1 and either post-operative or stable on at least two consecutive scans Current use of warfarin sodium or any other Coumadin®-derivative anticoagulant. Participant must be off Coumadin-derivative anticoagulants for at least 7 days prior to starting study drug. Low molecular weight heparin and Factor Xa antagonists are allowed History of clinically significant bleeding within 6 months of enrollment History of arterial thromboembolism within 12 months prior to enrollment Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 90 mmHg on antihypertensive medications) Any prior history of hypertensive crisis or hypertensive encephalopathy Clinically significant cardiovascular disease within 12 months prior to enrollment (or randomization), including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent Evidence of bleeding diathesis or coagulopathy History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study 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): 1.0-21.0, Food Allergy Wheat Allergy Age 1 year to 21 years of any sex and any race Physician-diagnosed food allergy to wheat with convincing clinical history of food allergy to wheat AND a skin prick test positive to wheat (diameter of wheal 3 mm or greater than negative control) or a detectable serum food-specific IgE level (ImmunoCAP > 0.35 kUA/L) to wheat within the previous 12 months or at the time of entry into the study If no history of clinical reactivity to wheat, then a positive skin prick test to wheat (diameter of wheal 3 mm or greater than negative control) OR a detectable serum food-specific IgE level to wheat within the previous 12 months or at the time of entry into the study Patients who meet any of the following are eligible for enrollment as study participants if they meet all other but will not undergo a Recent (within one year) failed open OFC Positive to wheat at CHCO Recent (within one year) exposure to wheat resulting in immediate IgE-mediated allergic symptoms (within 2 hours of ingestion; symptoms such as urticaria, angioedema, congestion, rhinorrhea, wheezing, respiratory compromise, hypoxia, hypotension) Written informed consent from parent/guardian and assent (when age appropriate) Willingness to submit specimen for laboratory serum IgE testing Willingness to submit lab specimen for ELISA testing Inability to discontinue antihistamines for skin prick testing and OFCs FEV1 value <80% predicted OR any clinical features of moderate or severe persistent asthma, as defined by the 2007 NHLBI guidelines table for classifying asthma, at the time of entry into the study Use of >500 μg/day fluticasone or equivalent Asthma requiring either hospitalization in the past year for asthma, or ER visit in the past 6 months for asthma Use of steroid medications (IV, IM or oral) for asthma in the following manners history of daily oral steroid dosing for >1 month during the past year, or steroid course/burst in the past 3 months (except for steroid dosing used in the treatment of an allergic reaction during the or steroid courses/bursts in the past year
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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): 30.0-85.0, Pain, Postoperative Ropivacaine Therapeutic Use Arthroplasty, Replacement, Hip THA within 48 hours and VAS>40 during active 30 degrees hip flexion despite conventional pain medication informed consent ASA 1-3 BMI 18-40 Unable to communicate in danish Allergic reactions toward drugs used Abuse of alcohol/drugs Unable to cooperate Pregnant women
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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, Ebola Virus The for the study are broad reflecting the target population that would eventually receive an efficacious vaccine Informed consent Age greater than or equal to 18 years Likely to be in the surrounding area of the vaccination center for at least one year Fever greater than or equal to 38.0 degrees Celsius History of EVD (self-report) Current pregnancy (a negative urine pregnancy test is required for women of child-bearing potential) Breast-feeding an infant Any condition which would limit the ability of the participant to meet the requirements of the study protocol
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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, Healthy All subjects must comply with all the following Having respected dietary restrictions 2 days before the visit Having obtained his/her or his/her legal representative's informed consent Subjects representing one or more of the following are excluded from participation in the study Pregnancy as per precaution principal to avoid risks linked to X-ray exposure Any pathology (infectious or other) having required an antibiotic therapy within 1 month prior to the beginning of the study Any therapy (contraception apart) within the 2 days before the visit day Subject who cannot be expected to comply with measures Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of 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): 18.0-45.0, Healthy Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25 kg/m2, Weight > or = 50kg In good health as judged by the investigator Without history of medication within 2 weeks before the test Non-allergic constitution, without known drug allergy Without history of major organ diseases Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration) History of abuse of Smoking, alcohol, or other drugs Severe hemorrhage factors to affect the venous blood collection Severe blood loss or blood donation within 3 months before the test Participation in other drug trials within 3 months before the test Usage of drugs known to have damage to the main organs within 3 months before the test Without good compliance, or unable to match with the test with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
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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, Empathy Food Allergy Employed at a quick-service restaurant Speaks English Work at a table-only establishment
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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): 30.0-999.0, Human Papilloma Virus Dysplasia CIN1 CIN2 • Women over 30 years of age who have a HPV positive test and normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia within three months of study entry Women must have had 2 other HPV positive tests with normal/negative cytology, atypical cells, ASCUS, or CIN1 or CIN2 cervical dysplasia greater than 6 months and no more than 18 months prior to study entry greater than 24 months prior to study entry Women of child bearing potential must have a negative urine pregnancy test within 7 days of therapy start Patients must have adequate hematologic, renal, and hepatic function as noted from labs within the previous 12 months: ANC >/= 1,500 cells/mm3, platelets 100,000 >/= cells/mm3; Creatinine clearance>/= 60 mL/min (estimated by Cockcroft Gault equation), total bilirubin, SGPT, SGOT, and alkaline phosphatase </= 1.5 times normal Patients of child-bearing age must agree to use effective methods of contraception (oral contraceptives, condoms, etc.) while on study • History of myocardial infarction within past 6 months, unstable angina, CHF, or uncontrolled hypertension (> 140/90) Women with a current or prior diagnosis of cancer Women with a current diagnosis of CIN3 cervical dysplasia Women that are pregnant or breast feeding Women with a history of Hepatitis (autoimmune, A, B, or C) or antigen positive Patients with history of significant psychiatric disorders (schizophrenia, bipolar, psychosis) or uncontrolled seizures Patients with significant medical co-morbidities at the discretion of the primary Gynecologist. Including immunosuppressive conditions (i.e. HIV+, rheumatoid arthritis, etc) or taking immune modulation mediations (i.e. immunosuppressants) Women that have taken AHCC within the past six months Women currently taking other immune modulating nutritional supplements Patients who have undergone a hysterectomy (supracervical hysterectomy allowed)
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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, Ischemic Preconditioning Patients with aneurysmal subarachnoid hemorrhage whose initial angiogram show an aneurysm and patients with clipped aneurysm will be eligible for enrollment Patients will be enrolled within 96 hours of bleeding onset, if informed consent is obtained from the participant or health care proxy, as appropriate Hunt Hess Scale > 4 Inability to undergo limb preconditioning due to local wound or tissue breakdown, history of peripheral extremity vascular disease or patient discomfort Inability to obtain informed consent from the patient or a health care proxy Ankle-brachial index < 0.7 Inability to start limb preconditioning within 4 days of bleeding Inability to precondition a leg that is not-plegic (that is preserved anti gravity strength) and has not been accessed for catheter angiography Age<18 years Pregnant women Prisoners
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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, Postpartum Hemorrhage A patient will be considered for in the study if she meets all of the following She has a term (≥37 completed weeks) live singleton gestation in cephalic presentation and has been admitted to the Labor and Delivery Unit She is in the latent phase of labor or has been admitted for induction of labor or at prenatal clinic visit She has had fewer than four prior vaginal deliveries She reports no allergy to misoprostol. The following factors or conditions will a patient from consideration as a subject The fetus has a known major fetal malformation or chromosome abnormality The gestation is multiple There is a breech or other malpresentation The patient reports involvement in another clinical trial currently or previously in this pregnancy The patient is expected to have a cesarean delivery
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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): 18.0-99.0, Total Atherosclerotic Occlusion of Radial Artery Patients referred for cardiac catheterization. - Absence of informed consent. 2: Known allergy to nitroglycerin. 3: Ad-hoc PCI 4: Previous ipsilateral TRA. 5: Warfarin or NOAC therapy. 6: Systolic blood pressure < 100 mmHg. 7: Critical aortic stenosis (AVA < 0.6 sq.cm) 8: Inability to administer unfractionated heparin. 9: Need for post-procedural use of heparin (UFH, LMWH) 10: Raynaud's disease. 11: Sheathless technique or use of > 11 cm sheath. 12: History of intractable headache of any cause OR Migraine headache
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0
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