topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 12.0-60.0, Recurrent Aphthous Stomatitis Criteria:• Confirmation of clinical diagnosis of aphthae Having the experience of oral aphthae at least once in a month Two weeks wash out periods after the last treatment History of any systemic disease Using drugs which affect immune system Pregnancy and breast feeding Aphthous related syndromes
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 1.0-45.0, Seasonal Influenza Healthy people with aged 1 to 45 years; 2. Previous history of not being vaccinated by any flu vaccines; 3. Women of childbearing potential agree to apply the contraceptive measures during the study period; 4. Do not have any acute or chronic diseases by screening; 5. Having the abilities of understanding and conforming the study plan; 6. Volunteer to the study; 7. Agree to vaccinate completely and conform the follow up procedure within 30 days after the first vaccination Having the suspected symptoms of infecting flu: cough, sore throat, stuffy or running nose, headache, malaise, myalgia and arthralgia, weakness, chilly or sweat; 2. A prior history of allergy to any components of candidate vaccine; 3. Sensitive to eggs or chicken protein, kanamycin, neomycin sulphate, formaldehyde, cetyltrimethylammonium bromide (CTAB) and polysorbate 80; 4. Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who are sexually active and have not used or do not plan to use acceptable birth control measures during the first 3 weeks after vaccination; 5. Being immuno deficiency due to treatment; 6. Using immunosuppressive drugs (belong to steroid group) within 06 months before vaccination; 7. Being sickness or cancer or HIV (+); 8. Participating in other study on drug or vaccination; 9. Receipt of other vaccine within 04 weeks before participating in the study; 10. Congenital malformation, mental disorder or members of family having the mental disorder; 11. Using immune globulin or blood products within 03 months before vaccination; 12. Having an acute or chronic diseases that can cause influence on the safety including: hepatic, renal, mental diseases or diabetes and transplantation; 13. Body temperature over 37.5 degree Celcius within 01 week before vaccination; 14. History of alcohol or drugs addicted within 05 years; 15. Planning to travel away from the study site among the visits
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 40.0-74.0, Cancers Cardiovascular Diseases Cataract Gastrointestinal Diseases Osteoporosis Fractures All women born between 1914 and 1948, living in central Sweden None
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Brain Stem Glioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Mixed Glioma Adult Solid Neoplasm Male Breast Carcinoma Recurrent Adult Brain Neoplasm Recurrent Breast Carcinoma Recurrent Colon Carcinoma Recurrent Melanoma Recurrent Non-Small Cell Lung Carcinoma Recurrent Ovarian Carcinoma Recurrent Ovarian Germ Cell Tumor Recurrent Pancreatic Carcinoma Recurrent Rectal Carcinoma Recurrent Renal Cell Carcinoma Stage III Pancreatic Cancer Stage III Renal Cell Cancer Stage IIIA Colon Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIA Ovarian Cancer Stage IIIA Ovarian Germ Cell Tumor Stage IIIA Rectal Cancer Stage IIIA Skin Melanoma Stage IIIB Breast Cancer Stage IIIB Colon Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIB Ovarian Cancer Stage IIIB Ovarian Germ Cell Tumor Stage IIIB Rectal Cancer Stage IIIB Skin Melanoma Stage IIIC Breast Cancer Stage IIIC Colon Cancer Stage IIIC Ovarian Cancer Stage IIIC Ovarian Germ Cell Tumor Stage IIIC Rectal Cancer Stage IIIC Skin Melanoma Stage IV Breast Cancer Stage IV Non-Small Cell Lung Cancer Stage IV Ovarian Cancer Stage IV Ovarian Germ Cell Tumor Stage IV Pancreatic Cancer Stage IV Renal Cell Cancer Stage IV Skin Melanoma Stage IVA Colon Cancer Stage IVA Rectal Cancer Stage IVB Colon Cancer Stage IVB Rectal Cancer Dose-escalation cohorts: Patients must have histologically and/or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; expansion cohort: patients must have histologically and/or cytologically confirmed breast cancer, malignant melanoma, colorectal cancer, pancreatic cancer, kidney cancer, high grade glioma, non-small-cell lung cancer, or ovarian cancer Patients must have measurable or non-measurable disease; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; measurable disease is not required to participate in this trial No limitation on prior therapy; however, there must be at least a 4 week interval between initiation of study treatment and any prior radiotherapy or systemic therapy, 6 weeks if the last regimen included carmustine (BCNU) or mitomycin C; exceptions may be made however, for low dose, non-myelosuppressive radiotherapy for symptomatic palliation; please contact the Princess Margaret Hospital (PMH) Phase I Consortium Central Office coordinator or the Principal Investigator if any questions arise about interpretation of this criterion Life expectancy of greater than 12 weeks Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%) Leukocytes >= 3.0 x 10^9/L Absolute neutrophil count >= 1.5 x 10^9/L Platelets >= 100 x 10^9/L Hemoglobin >= 90 g/L (or >= 9 g/dL) International normalized ratio (INR) =< 1.3 Patients who have had systemic therapy or radiotherapy or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier Patients may not be receiving any other investigational agents within the past 30 days or have been previously treated with a gamma-secretase inhibitor and/or cediranib; exposure to other angiogenesis inhibitors (e.g. sorafenib, bevacizumab) is acceptable Patients with any meningeal metastases or untreated known brain metastases should be excluded from this clinical trial; patients with treated brain metastasis with radiologic and clinical evidence of stability, with no evidence of cavitation or hemorrhage in the brain lesions, are eligible providing that they are asymptomatic and do not require corticosteroids (must have discontinued steroids at least 1 week prior to randomization) History of allergic reactions attributed to compounds of similar chemical or biologic composition to RO4929097 and/or cediranib used in the study Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible (except low dose warfarin for prophylaxis for central catheters) Patients who are taking concurrent medications that are strong inducers/inhibitors or substrates of cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) should be switched to alternative medications to minimize any potential risk; if such patients cannot be switched to alternative medications, they will be ineligible to participate in this study Patients with any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, active peptic ulcer disease, short gut syndrome, malabsorption syndrome of any type, total or partial bowel obstruction or inability to tolerate oral medications) that potentially impairs their ability to swallow or absorb are excluded Patients who are serologically positive for hepatitis A, B or C, or have a history of liver disease, other forms of hepatitis or cirrhosis are ineligible Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, hypophosphatemia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation are excluded from this study Note: it is acceptable to use corrected calcium when interpreting calcium levels
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Human Papillomavirus Prevention Mother is greater than or equal to 18 years of age Mother has a daughter who is between the ages of 11-15 years Daughter has not received any doses of the HPV vaccine When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated." Cannot read/speak English
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-30.0, Polycystic Ovary Syndrome Obesity Women between the ages of 18-30, inclusive BMI greater than or equal to 25 Sedentary lifestyle not currently exercising more than 60 minutes per week A medical diagnosis of polycystic ovary syndrome. The diagnosis will be compared with the most recent international criteria1. Together with irregular menses (fewer than 6 cycles per year), participants must also have at least one of the following characteristics; 1. presence of polycystic ovaries on transvaginal ultrasound, >10 cysts, 2-8 mm in diameter (ultrasound will not be done in this study however; ultrasound reports will be used if available) and/or 2. clinical manifestations (hirsutism) examined by the PI at the screening visit or biochemical evidence (elevated testosterone or free androgen index) of hyperandrogenism, determined by fasting blood sample collected during the screening visit Women enrolling for the non-PCOS control group are required to have regular menstrual cycles (one cycle per month) Individuals with a history of cardiovascular disease or an elevated blood pressure above 160/90 mmHg Individuals with a history of Diabetes (Type 1 or Type 2) Individuals with a history of Kidney, Liver or Heart disease Individuals with untreated thyroid disease Individuals who smoke Individuals who exercise more than 60 minutes per week Individuals who use medications including contraceptives (medications used to treat thyroid disease are permitted) Individuals with alcoholism or other substance abuse Individuals who are pregnant or lactating (breast feeding) Individuals who become pregnant throughout the study will be excluded
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 2.0-6.0, Healthy American Society of Anesthesiologist physical status I or II 6 year-old children patients undergoing tonsillectomy and adenoidectomy upper respiratory disease mental retardation
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-75.0, Elective Cranial Procedures With Dural Incision Pre-Operative Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered) Intra-Operative Subject's linear extent of durotomy is ≥2 cm Subject's dural margins from the edges of bony defect are ≥3 mm throughout Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an if cells are appropriately sealed (e.g. bone wax) Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an criterion) Subject has a systemic infection or evidence of any infection near planned operative site. Intra-Operative Subject has an Incidental finding that meets any pre-operative criterion listed above Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Healthy Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, inclusive? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history of allergy or hypersensitivity to zonisamide or sulfonamides? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen, or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Has s/he consumed grapefruit or grapefruit juice during the 7-day period preceding study initiation? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? Has s/he donated or lost blood, or participated in a clinical study which involved the withdrawal of a large volume of blood (480 mL or more), during the six week period preceding study initiation?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-85.0, Healthy For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.) For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Influenza H1N1 Recipients of H1N1 influenza vaccine Healthy individuals with no signs of influenza or other infectious disease Signs of influenza or other infectious disease in 1 month before study participation
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza Maternal Subject Women age 18-49 years of age (inclusive) within 28-120 days of delivery Is in good health, as determined by vital signs (heart rate </=100 beats per minute (bpm); blood pressure: systolic <150 mm Hg; diastolic <90 mm Hg; oral temperature <100.0 degrees Fahrenheit), medical history and a targeted physical examination if indicated based on medical history Willing and capable of providing written informed consent for herself and infant Available for entire study duration, clinic visits and phone calls Planning on breast feeding from time of vaccination through 28 days post-vaccination. Breast milk must be at least one half of the source of the infant's feeding Willing to practice adequate contraception for at least 28 days after receipt of study vaccine if not surgically sterile via post-partum tubal ligation, bilateral oophorectomy or hysterectomy. Adequate contraception may but is not limited to, abstinence, monogamous relationship with a vasectomized partner, barrier methods such as condoms or diaphragms with spermicides, or licensed hormonal methods that are compatible with breastfeeding an infant May be reached by any IRB-approved form of communication during study period. May telephone, email, web based, social media, and/or text messaging, based on specific local IRB recommendations Agree to sign a medical release for herself and her infant (if needed) so that study personnel may obtain medical information about her or her infant's health. Infant The infant(s) should be in good health as assessed by medical history, interview, rectal temperature and a targeted physical examination based on medical history Infant born greater than or equal to 36 weeks gestation Maternal Subject History of receipt of licensed influenza vaccine for the current influenza season. (If enrolled in 2011-2012 season [October 2011 February 2012], subject must not have received 2011-2012 influenza vaccine. If enrolled in the 2012-2013 season [July 2012 or later], subject must not have received 2012-2013 influenza vaccine) History of previous participation in this study Known allergy to eggs, egg proteins or other components in the vaccines (i.e. formaldehyde, polyethylene glycol, p-isooctylphenyl ether, sucrose, gelatin, polysorbate 80, gentamicin, arginine, sodium phosphate, sodium chloride, octylphenol ethoxylate, EDTA) If enrolled in the 2011-2012 season, known or suspected latex allergy. For the 2012-2013 season, known or suspected latex allergy is not a reason for exclusion History of severe reactions following immunization with contemporary influenza virus vaccines Received any other licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to vaccination in this study, or expects to receive a licensed vaccine during the 28 days after vaccination in this study Received an experimental/investigational agent (vaccine, drug, biologic, device, blood product, or medication) within 28 days prior to vaccination in this study, or expects to receive an experimental/investigational agent within the study time period (180 days after vaccination in this study) Received antiviral agent against influenza A and/or B within 48 hours prior to vaccination in this study. Antiviral agents should not be administered until 2 weeks after vaccination in this study unless medically necessary
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-40.0, Influenza Subject must have a BMI >18.5 and ≤ 28.5 kg/m2 Subject must have no clinically significant abnormal findings, as judged by the Investigator, on the physical examination, ECG, medical history or clinical laboratory results during screening Subject must be a non-user of tobacco products, or smoke ≤ 10 cigarettes per day (minimum 6 months prior to first dose) Subject must have a negative urine screen for drugs of abuse and a negative alcohol breath test at screening and check-in Subject must refrain from consuming alcohol for 72 hours prior to each dose Subject must be able to communicate well with the Investigator, to understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator Subject must give voluntary written informed consent to participate in this trial Subject must not have previous influenza vaccination within the 12 months prior to test drug vaccination Subject must not have had an influenza like illness within the 3 months prior to test drug vaccination Subject must not have a history or presence of significant neurological, cardiovascular, pulmonary (including asthma), hepatic, metabolic, rheumatic, autoimmune, haematological or renal disorder Subject must not have an oral temperature >38°C on day of vaccination (otherwise subject maybe be re-assigned to a subsequent cohort) Subject must not suffer from an inherited or acquired immunodeficiency Subject must not suffer from a disease or be undergoing treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or non-steroidal anti-inflammatory drugs Subject must not have a serologically positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) Subject must not have a history of severe allergic reactions and/or anaphylaxis Subject must not have any arm rash or tattoos which could confound the interpretation of any injection site reactions Subject must not have participated in a previous clinical trial within 90 days prior to the first vaccination
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 10.0-999.0, Infections, Papillomavirus Subject must be female Subject must be aged 10 and over Subject with obvious fever Subject with obvious severe acute disease Subject with hypersensitivity to any component of Cervarix® Other than above, subject who is in inappropriate conditions for vaccination
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 65.0-999.0, Immunity to Influenza Vaccine healthy aged 65+ years <65 years influenza vaccine allergy Guillain-Barre weight <110 pounds
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Healthy Volunteers Influenza NIH employees scheduled to receive the Influenza and H1N1 vaccines through OMS. 2. Health status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol. 3. Age 18 years and older (no upper limit). 4. Able to comprehend the investigational nature of the protocol and provide informed consent Recipient of another vaccine or immune modulating drug within 6 months prior to study entry. 2. Severe allergies to eggs or their products. 3. Prior severe reactions to vaccines. 4. Participation on any blood collection or blood donation procedure during study participation. 5. Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual)
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.5-999.0, H1N1 Virus Participants of the clinical service evaluation of novel H1N1v vaccine First or second blood sample for the clinical service evaluation successfully collected Withdrawn from clinical service evaluation of novel H1N1v vaccine Second blood sample for the clinical service evaluation not collected
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Tuberculosis, Multidrug-Resistant Individuals with pulmonary TB who have a risk factor for MDR-TB and live within a zone that has implemented the intervention of the overarching study (i.e. within the catchment area of an intermediate laboratory which has implemented DST as per NTP protocol) Non Spanish speakers
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Healthy Completed a medical screening questionnaire English speaking No allergies to the drugs Able to complete the forms If a woman of childbearing age, agree to use contraception History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age) Use of any medication that would contraindicate benzodiazepine administration Pregnant or nursing
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-60.0, Cervical Spinal Cord Injury Cervical Spinal Cord Injury (C5-C7) Posterior Deltoid to Triceps Tendon Transfer at least one year post-surgery Biceps to Triceps Tendon Transfer at least one year post-surgery Subjects will be excluded from the studies if there is presence of concurrent severe medical illness, including unhealed decubiti use of baclofen pumps existing infection cardiovascular disease significant osteoporosis (as indicated by a history of fractures following injury) or a history of pulmonary complications or autonomic dysreflexia
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Seasonal Influenza seasonal influenza vaccine indications according to the CDC employees of partner corporations executing study none
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 10.0-999.0, Aphthous Stomatitis A history of Recurrent aphthous stomatitis 2. Patients who had symptoms such as burning sensation, pain 3. Patients not on any immunosuppressive or immunomodulatory treatment . 4. Patients of both sexes over 10 years with recurrent aphthous stomatitis 5. Patients who gave written informed consent 6. Patients who were willing for evaluation after therapy and every 1 month up to 5months Participants demonstrating drug consumption in the 7 past months 2. pregnancy or lactation 3. Any kind of localized or systemic disease, especially ulcerative colitis , chorn disease and Bechet's syndrome 4. Smokers 5. patients receiving immunosuppressive treatments or any kind of systemic or local drugs especially systemic antibiotics (in past 2 weeks ) and oral antihistamines( in past month ) were either eliminated or asked to discontinue their treatment for a minimum of one month before entering the investigation
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 50.0-75.0, Colorectal Cancer Participants must be primary care patients one of 6 participating clinics 2. Participants must be aged 50-75 3. Participants must have received a flu shot during a primary care visit on any date during the 2009-10 flu shot season (beginning September 28, 2009 and ending at the end of January, 2010) None
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Cow's Milk Allergy Proved cow"s milk allergy Pregnant women
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Influenza General good health determined by a screening evaluation ≤120 days prior to IMP administration and on the day of admittance to quarantine Using methods of contraception, (e.g. spermicidal gel plus condom) for the entire duration of the study, up to the Study Completion visit, and refrain from fathering a child in the three months following study drug administration Negative HIV, hepatitis B and C antibody screens Negative class A drugs, alcohol and nicotine screen Seronegative (≤10 HAI) for challenge virus Have not been vaccinated for influenza virus since 2006 (as determined in the medical history) or had a known influenza-like illness in the current season, defined as in the last 12 months Presence of any significant acute or chronic, uncontrolled medical or psychiatric illness, including but not exclusive to the conditions listed in Appendix 2, that in the view of the Investigator is associated with increased risk of complications of respiratory viral illness Abnormal pulmonary function as evidenced by clinically significant abnormalities in spirometry Presence of household member or close contact who is: less than 3 years of age; known immunodeficient; receiving immunosuppressants; undergoing/soon to undergo chemotherapy; diagnosed with emphysema or COPD; is elderly residing in a nursing home; severe lung disease or medical condition; received a transplant (bone marrow or solid organ) History of asthma, COPD, pulmonary hypertension, reactive airway disease, or any chronic lung condition of any aetiology Any laboratory test or ECG which is abnormal and deemed by the investigator to be clinically significant Venous access inadequate for phlebotomy demands Regular daily smokers during the 6 months prior to study entry or those who have a significant history of any tobacco use at any time Subject is diabetic History or evidence of autoimmune disease or known impaired immune responsiveness Recent and/or recurrent history of autonomic dysfunction
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 25.0-999.0, Influenza Healthy individuals aged 25-40 years, or ≥65 years old. 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 trivalent Influenza vaccination Receipt of immune products Receipt of blood products 3 months prior to study entry or expected receipt through 6 months after study entry Receipt of any live virus vaccines within 4 weeks prior to study entry or expected receipt within 4 weeks after study entry* Receipt of any inactivated vaccine within 2 weeks or expected receipt within 2 weeks after study entry* Receipt of the 2010-2011 influenza vaccine 2. Documented influenza infection during the 2010-2011 influenza season. Not excluded from the study, volunteers with prior upper respiratory infections during the 2010-2011 influenza illness. 3. Presence of co-morbidities or immunosuppressive states such as Chronic medical problems including (but not limited to) insulin dependent diabetes, severe heart disease, severe lung disease, severe liver disease, severe kidney disease, auto immune diseases, severe gastrointestinal diseases, and uncontrolled hypertension Alcohol or drug abuse and psychiatric conditions that in the opinion of the investigator would preclude compliance with the trial or interpretation of safety or endpoint data Impaired immune function or chronic infections including (but not limited to) HIV, hepatitis B or C; organ transplant; cancer; current and/or expected receipt of chemotherapy, radiation therapy or any other cytotoxic or immunosuppressive therapy [i.e. more than 10 mg of prednisone given daily or on alternative days for 2 weeks or more in the past 3 months*; receipt of high-dose inhaled steroids is also an (nasal and topical steroids are allowed.)], congenital immunodeficiency, anatomical or functional asplenia Pregnancy or breast feeding 4. Conditions that could affect the safety of the volunteers such as
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza Subjects who the investigator believes can and will comply with the requirements of the protocol Written informed consent obtained from the subject Male and female adults, 18-49 years of age at the time of the first vaccination Satisfactory baseline medical assessment by history and physical examination Safety laboratory test results within the parameters specified in the protocol Access to a consistent means of telephone contact Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of first vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series Medical history of physician-confirmed infection with an H5N1 virus Increased risk of occupational exposure to H5N1 influenza viruses Previous vaccination at any time with an H5N1 vaccine, or with an oil-in water adjuvanted influenza vaccine Planned administration of an adjuvanted influenza vaccine or an H5N1 pandemic vaccine during the entire study period Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Presence of significant acute or chronic, uncontrolled medical or psychiatric illness Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Evidence of current substance abuse, including alcohol, by medical history Presence of a temperature >= 38.0ºC (≥100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first dose Diagnosed with cancer, or treatment for cancer, within 3 years. Persons with a history of cancer who are disease-free without treatment for 3 years or more are eligible
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-40.0, Genital Tract Mucosal Immunity Genital Tract Microflora Non-pregnant, healthy females who are seeking an IUD for contraception 2. Age 18-40 years, inclusive at the time of enrollment 3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days 4. Willing and able to sign the informed consent and to comply with the study protocol for healthy control subjects: 1. Non-pregnant, healthy females 2. Age 18-40 years, inclusive at the time of enrollment 3. History of regular menstrual cycles defined as occurring every 21-35 days when not using hormones and with a variation of typical cycle length of no more than 5 days 4. Willing and able to sign the informed consent and to comply with the study protocol 5. Prior surgical sterilization or heterosexually abstinent Use of any hormonal or intrauterine contraceptive method within the past two months 2. Use of DMPA within the past 10 months 3. Any of the following within the past two months Pregnancy or breastfeeding Surgery/biopsy of the vulva, vagina, or cervix History of STI New sexual partner 4. Evidence of vaginal/pelvic infection on screening Abnormal wet mount (see description above) Pelvic exam findings clinically consistent with infection Positive screen for Gc, Ct, or HIV (will be excluded post randomization) 5. Active HSV/ulcerative disease in the genital tract or perineum 6. History of immunosuppression (diabetes, HIV, chronic steroid use) 7. Use of vaginal product (N9, microbicide, douche, antifungal, steroid, or hormone) within the past 30 days 8. Use of any systemic or vaginal steroid or antibiotic within the past 30 days 9. Vaginal or anal intercourse within 1 week of sample collection 10. Heterosexual vaginal intercourse since last menses without condom use 11. History of hysterectomy 12. History of malignancy in the uterus or cervix 13. Uterine anomaly (bicornuate uterus, uterine septum, or uterine didelphys) 14. Allergy to copper and/or intolerance to levonorgestrel
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Bacillus Anthracis (Anthrax) Infection Be between 18 and 50 years of age, inclusive, at the time of enrollment Be in good health as determined by the investigator from medical history and a physical examination If a pre-menopausal female, must be using acceptable methods of birth control Have all hematology and chemistry parameters (measured at Screening) within the laboratory's normal range Have negative values for the following tests at Screening: Hepatitis C antibody, anti-Human Immunodeficiency Virus (Anti-HIV-1/-2/-O), and anti-Hepatitis B Core Antigen (Anti-HBc) Be willing and capable of complying with all aspects of the protocol through completion of the required visits Have not donated blood in the preceding 8 weeks and are willing to not donate blood or plasma within 56 days after dosing Have adequate venous access for repeat phlebotomies Have read, understood and signed an informed consent form Key A known anaphylactic response, severe systematic response, or serious hypersensitivity reaction to a prior immunization Prior immunization with anthrax vaccine, recombinant Protective Antigen (rPA) vaccine, or known exposure to anthrax organisms Have previously served in the military or plans to enlist in the military from Screening through Day 84 Have participated in anthrax therapeutic or vaccine trials (monoclonal anti-protective antigen (PA) or anthrax immune globulins or anthrax vaccines) Participation in any investigational clinical trial within 30 days preceding the Screening visit or planning to participate in a clinical trial requiring dosing through the Day 194 visit A history of drug or alcohol abuse within 12 months prior to Screening, or a positive result on a urine drug screen for amphetamines, barbiturates, benzodiazepines, cocaine, marijuana, methylenedioxymethamphetamine opiates, oxycodone, phencyclidine, propoxyphene, or tricyclic antidepressants Blood pressure greater than 145 millimeters of mercury (mmHg) systolic or 90 mmHg diastolic Past history of significant autoimmune disease such as rheumatoid arthritis, lupus erythematous, psoriasis, glomerulonephritis, or autoimmune thyroiditis A medical condition that, in the opinion of the Principal Investigator (PI), could adversely impact the subject's participation, safety, or conduct of the study
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Pain Retinopathy of Prematurity Infants admitted to the Pennsylvania Hospital NICU who require an ophthalmologic examination Infants with congenital anomalies, seizures, or other neurologic conditions or malformations that may alter the pain response Infants with corneal abrasions, corneal ulcers or other relative or absolute contraindications to proparacaine administration
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 5.0-22.0, Hand, Foot and Mouth Disease Healthy subjects aged from 5 to 22 years old as established by medical history and clinical examination The subjects or their guardians are able to understand and sign the informed consent Had never received the vaccine against EV71 Subjects who can and will comply with the requirements of the protocol Subject that has a medical history of HFMD subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine Family history of seizures or progressive neurological disease Family history of congenital or hereditary immunodeficiency Women of pregnancy, lactation or about to be pregnant in 60 days Autoimmune disease or immunodeficiency Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws Any prior administration of administration of immunoglobulins
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Influenza Male or Female, of all ages (assuming appropriate consent is obtained). 2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI). For example: 1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days. 2. Nasal congestion 3. Rhinorrhea 4. Sore throat 5. Cough 6. Headache 7. Myalgia 8. Malaise Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes. 2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days. 3. Unable to understand and consent to participation; for minors this includes parent or legal guardian
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-55.0, Postpartum Period age 18 years or older speak either English or Spanish desire to use an IUD as their postpartum contraception (IUD arm) do NOT desire an IUD as their contraception (Diary Only arm) plan to deliver at Baystate Medical Center history of sexually transmitted infection during the three months prior to enrollment desiring of another pregnancy within six months of giving birth routine contraindications to IUD cavity-distorting uterine fibroids or uterine anomalies known or suspected uterine or cervical neoplasia acute liver disease or liver tumor history of breast cancer
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-55.0, Influenza Provision of signed and dated, written informed consent prior to any study-specific procedures Subjects must be able to understand and be willing to comply with study procedures, restrictions, and requirements Healthy male and non-fertile female subjects aged 18 and 55 years inclusive Female subjects must have a negative urine pregnancy test at screening must not be lactating or breastfeeding and must be of non-childbearing potential Male subjects should be willing to use barrier contraception during sexual intercourse Body weight 50 to 100 kg inclusive and body mass index (BMI) 18 to 30 kg/m2 inclusive Clinically non-significant findings on physical examination in relation to age Negative Rapid Flu Test (TRU FLU® kit) Negative nasal examination upon admission to the study center History and/or presence of any clinically significant disease or disorder such as cardiovascular, pulmonary, renal, hepatic, neurological, gastrointestinal and psychiatric/mental disease/disorders History and/or presence of hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs. Subjects with a surgical history of the gastrointestinal tract should also be excluded from participation in the study Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the administration of the investigational product which is symptomatic enough to affect study conduct or the well-being of the subject History and/or presence of asthma or recurrent sinusitis. Active rhinitis at screening or upon admission to the study center Any clinically significant nasal septum deviation, presence of septum perforations, and history of recurrent epistaxis and nasal polyps Subjects with a history of sinus surgery and/or persistent hypertrophic inferior turbinates History of vaccination with live vaccine within 7 days or attenuated vaccine within 14 days of the administration of the investigational product Any clinically significant abnormalities in clinical laboratory safety assessment results A positive result at screening on serum hepatitis B surface antigen, hepatitis C antibodies and HIV antibodies Significant orthostatic reaction at screening or upon admission to the study center as judged by the Principal Investigator
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Fasting Is the individual a healthy, normal adult man and women who volunteers to participate? Is s/he within 18 and 45 years of age, inclusive? Is his/her BMI between 19 and 30, inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Fed Is the individual a healthy, normal adult man and women who volunteers to participate? Is s/he within 18 and 45 years of age, inclusive? Is his/her BMI between 19 and 30, inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? A no answer to any of the above questions indicates that the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza for study entry and Dose 1 Are males or non-pregnant females between the ages of 18 and 49 years, inclusive Women of childbearing 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 or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods) during the study for at least 30 days following the last vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF) Are in good health, as determined by vital signs (oral temp, pulse and blood pressure), medical history and complete physical examination (without genital and rectal exam) to ensure no existing chronic medical diagnoses or conditions are present ESR less than 30 mm per hour For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the first vaccination Are able to understand and comply with planned study procedures Provide written informed consent prior to initiation of any study procedures. for Dose 2 Have received the first dose of study vaccine For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the second vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF) for study entry and Dose 1 Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal and chicken protein), or allergy to squalene-based adjuvants Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination Have long term use (defined as taken for 2 weeks or more in total at any time during the past 2 months) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids); or high-dose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent); or systemic corticosteroids of any dose within the past 4 weeks Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years Receiving systemic, prescription medications for the treatment of chronic medical conditions, unless such use is on a PRN (as needed) basis only. Non-PRN use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Note: Topical, nasal, and inhaled medications; vitamins; and contraceptives are also permitted Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza for study entry and Dose 1 Are males or non-pregnant females between the ages of 18 and 49 years, inclusive Women of childbearing 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 or diaphragms with spermicide or foam, intrauterine devices, and licensed hormonal methods) during the study for at least 30 days following the last vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF) Are in good health, as determined by vital signs (oral temp, pulse and blood pressure), medical history and complete physical examination (without genital and rectal exam) to ensure no existing chronic medical diagnoses or conditions are present ESR less than 30 mm per hour For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the first vaccination Are able to understand and comply with planned study procedures Provide written informed consent prior to initiation of any study procedures. for Dose 2 Have received the first dose of study vaccine For women of childbearing potential, negative urine or serum pregnancy test within 24 hours prior to the second vaccination. Adherence to contraceptive method will be captured on the appropriate case report form (CRF) for study entry and Dose 1 Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol-9, thimerosal and chicken protein), or allergy to squalene-based adjuvants Women who are breastfeeding or plan to breastfeed at any given time from the first vaccination until 30 days after the last vaccination Have long term use (defined as taken for 2 weeks or more in total at any time during the past 2 months) of high dose oral or parenteral glucocorticoids (high dose defined as prednisone >/= 20 mg total daily dose, or equivalent dose of other glucocorticoids); or highdose inhaled steroids (high dose defined as >800 mcg/day of beclomethasone dipropionate or equivalent);or systemic corticosteroids of any dose within the past 4 weeks Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months Have an active neoplastic disease or a history of any hematologic malignancy Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis Hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years Receiving systemic, prescription medications for the treatment of chronic medical conditions, unless such use is on a PRN (as needed) basis only. Non-PRN use of systemic, over-the-counter medications and PRN systemic, prescription medication may be allowed if, in the opinion of the investigator, they pose no additional risk to subject safety or assessment of immunogenicity/reactogenicity. Note: Topical, nasal, and inhaled medications; vitamins; and contraceptives are also permitted Received pre-medication with analgesic or antipyretic agents in the 6 hours prior to first vaccination, or planned medication with analgesic or antipyretic in the week following first vaccination. This criterion should not preclude subjects receiving such medication if the need arises. However, pre-medication is to be discouraged
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-65.0, Asthma Healthy females as determined by an experienced study physician, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and electrocardiogram (ECG). A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures Females must be either Of non-childbearing potential, defined as pre-menopausal females with a documented tubal ligation or hysterectomy or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<140 pmol/L) is confirmatory]. [Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 9.4 of the protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.] Of child-bearing potential and agrees to use one of the contraception methods listed in Section 9.4 of the protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 3 months after the last dose Aged 18-65 years Body Mass Index (BMI) of 18-35 kilogram per sqare metre (km/m2) Subjects must demonstrate their ability to swallow an empty size 000 capsule Must be willing and able to participate in the whole study and must provide written informed consent Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5xUpper Limit of Normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) QTcB or QTcF < 450 msec Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months or 4 months if new chemical entity (NCE) Subjects who have previously been enrolled in this study Subjects who have ever sought advice from or been referred to a General Practitioner or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;) Positive drugs of abuse test result Regular alcohol consumption >14 units per week (1 Unit = ½ pint beer, a 25 milliLitre (mL) shot of 40% spirit or a 125 mL glass of wine) Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at screening Radiation exposure from clinical trials, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 milliSieverts (mSv) in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study Subjects must not have had any 14C exposure within the last 12 months
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Postpartum Depression Women who are currently pregnant and who have a history of MDD. In order to minimize heterogeneity in the sample, all women must be currently taking a serotonin reuptake inhibitor (SSRI) antidepressant medication or not taking antidepressants. We will attempt to recruit approximately 50% in each category (SSRI versus no medications). If a woman becomes depressed during the study she will be referred to her treating psychiatrist or given appropriate clinical care. We will continue to follow women for the specified time course even if she placed on an (any) antidepressant medication during the course of the study Diagnosis of bipolar disorder Current active suicidal ideation or medical instability Active substance abuse or dependence during the last 90 days
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 40.0-84.0, Breast Cancer women aged 40 through 84 years old in the Fallon Community Health Plan, Blue Cross, Tufts or Harvard Pilgrim health plans for 18 or more months has a current Reliant Medical Group (formerly called Fallon Clinic) primary care provider has working telephone significant cognitive impairment serious illness, precluding screening bilateral mastectomy life expectancy less than 5 years
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Very Low Birth Weight Baby Pneumonia A cluster was eligible to participate if it Is located in Kintampo North or South Districts (this is the core study area for KHRC) Is primarily rural (in practice, this excludes Kintampo, which is a small city of approximately 40,000 people) Is operationally feasible (in practice, this excluded a handful very small, isolated clusters that would have presented extraordinary logistical challenges) Is home to women who primarily deliver at one of our four staffed birth facilities (in practice this excluded one village on the edge of the study area, in which women travel to another district for deliveries). A woman will be eligible to participate in the study if she Is in the first or second trimester of pregnancy (gestational age ≤ 24 weeks gestation; this is to ensure that the intervention is actually delivered prior to 27 weeks) Is carrying a live singleton fetus (twins will be excluded) Is the primary cook in her household or compound; and Is a non-smoker
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Hyperprolactinemia Subjects will be females of any race, with an age range of 18?50 Subjects will meet DSM-IV TR (APA, 2000) for either schizophrenia, schizoaffective disorder, or bipolar disorder. A best estimate diagnostic approach will be utilized in which information from the Structured Clinical Interview for DSM-IV (First et al, 1997) is supplemented by information from family informants, previous psychiatrists, and medical records to generate a diagnosis Women will need to be taking a stable dose of antipsychotic regimen for at least two months and are considered to have stable symptoms by the treating psychiatrist. This regimen must any form of risperidone or paliperidone All women will have a prolactin level > 24 ng/ml (either identified at screening or from the past 6 weeks in the medical record) All women will have evidence of a prolactin related hormonal side effect (amenorrhea, oligomenorrhea or galactorrhea). This will be determined by patient report/history and medical record/clinician interview. Oligomenorrhea is defined as infrequent, irregularly timed episodic bleeding occurring at intervals of more than 35 days from the previous menstrual cycle and amenorrhea is defined as absence of menstruation for three menstrual cycles or 6 months (Berek et al. 2002). Galactorrhea is defined as lactation or copious milk secretion Subjects must be judged competent to participate in the informed consent process and provide voluntary informed consent, by scoring a 10 out of 12 on the Evaluation to Sign Consent (ESC) Postmenopausal women will be excluded. Since it may be difficult to determine menopause in patients with amenorrhea, any women more than 45 years will be assessed for menopausal symptoms such as but not limited to or by: hot flushes, depression, excitability and fatigue. A medical doctor will advise on the menopausal status Patients with a history of a pituitary tumor (microadenoma, macroadenoma, neoplasm) will not be included in the study. Previous medical records will be obtained if possible to examine prolactin levels and medical histories Subjects with documented Cushing's disease, or who are pregnant or currently lactating post pregnancy will be excluded Subjects who meet DSM-IV TR for alcohol or substance abuse within the last month are excluded. Subjects with nicotine use or dependence will not be excluded Medications which may increase prolactin or cause sexual dysfunction, including: metoclopramide, methyldopa, reserpine, amoxapine, droperidol, prochlorperazine, promethazine, bromocriptine, cabergoline, pergolide, There are many medications that may affect sexual function (not hormonal side effects) unrelated to dopamine transmission. These are only permitted as long as the subject has been receiving them for greater than 4 weeks (SSRIs, mood stabilizers, diuretics, antihypertensives, H2antagonists, bupropion). We allow these medications to enhance generalizability
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 19.0-999.0, Metabolic Syndrome presence of metabolic syndrome by International Diabetes Foundation referral to metabolic syndrome program at St. Paul's Hospital age > 19 years unwillingness to participate in research study unwillingness to comply with dietary intervention following a weight reducing diet abusing alcohol or other psychoactive substances on psychiatric medication associated with weight gain plans to travel during the study period food allergies or intolerances that will interfere with their adherence to either of the study diets
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Mucosal Immunity Healthy men and women ages 18-50 years Non-smokers (defined as no tobacco use within the last 12 months and less than 10 pack-year lifetime tobacco use) Willing and able to provide written informed consent Able to speak and understand English Women of childbearing potential must have a negative serum pregnancy test Influenza vaccination within 6 months prior to screening date Symptoms of respiratory infection during the 14 days prior to screening Temperature >38.3o C during the period spanning 72 hours prior to screening and the time of immunization History of allergy to egg, influenza vaccine or vaccine ingredients History of Guillain-Barre syndrome History of Bell's palsy Tonsillectomy, adenoidectomy or prior surgery to the paranasal sinus cavity Physician diagnosis of or personal history of allergic or chronic rhinitis Physician diagnosis of or personal history of asthma Acute sinusitis within 30 days prior to screening
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Healthy The patient must have given his/her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient Patient is pregnant Patient is breast feeding The patient is a smoker The patient has, or has a history of, chronic respiratory insufficiency The patient has a contra-indication for a treatment necessary in this study
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Pain age 18-45 yrs selecting intrauterine device contraception able and willing to consent non-English speaking current intrauterine device use expulsion of intrauterine device within 2 weeks allergy to lidocaine or water based lubricant
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Influenza Subjects who the investigator believes can and will comply with the requirements of the protocol A male or female 18 to 64 years of age at the time of the first vaccination Written informed consent obtained from the subject Stable general health as established by medical history and clinical examination before entering into the study Subject access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device Female subjects of non-childbearing potential may be enrolled in the study Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after completion of the vaccination series Previous vaccination at any time with an H5N1 vaccine Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period Presence of significant acute or chronic, uncontrolled medical or psychiatric illness Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports Presence of a temperature ≥ 38.0ºC, or acute symptoms greater than "mild" severity on the scheduled date of first dose Diagnosed with cancer, or treatment for cancer, within 3 years Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination Receipt of systemic glucocorticoids within 1 month prior to study enrolment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrolment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed Receipt of any immunoglobulins and/or any blood products within 3 months before first study vaccination or planned administration of any of these products during the study period Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to dosing, are eligible. Persons receiving prophylactic antiplatelet medications, and without a clinically-apparent bleeding tendency, are eligible
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 2.0-99.0, Argininosuccinic Aciduria Carbamoyl-Phosphate Synthase I Deficiency Citrullinemia Ornithine Carbamoyltransferase Deficiency Hyperargininemia N-Acetylglutamate Synthase Deficiency Patients: Any gender and ethnicity age 2 years and older with a diagnosis of a urea cycle disorder are eligible to enroll in this protocol. Patients need to be medically and nutritionally managed by a local metabolic provider. If necessary, we will obtain written consent from the patient to review medical records from their home physician to confirm eligibility. Healthy Volunteers: Any gender and ethnicity age 2 years and older are eligible to enroll in this protocol. Have access to own personal medical provider <TAB> Less than 2 years of age Inability to travel to NIH because of their medical condition Recent (6 month) history of vaccination or immune modulating drug Severe reactions to eggs and or latex History of severe reactions to previous immunizations (e.g. hives, rash, difficulty breathing) Persons without a personal medical provider Persons with current infections or under care of medical provider for an ongoing medical issue
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Influenza Women in third trimester of pregnancy (≥ 28 weeks gestational age based upon last menstrual period, ultrasound or uterine height). 2. Subject is able to understand and comply with planned study procedures. 3. Subject has provided written informed consent prior to initiation of any study procedures. 4. Subject intends to reside in the study area until her newborn infant is 6 months of age Member of a household which already has a woman who is participating or has participated in this study 2. History of severe reactions following previous immunization with influenza or meningococcal vaccines 3. History of Guillain-Barré Syndrome 4. Known allergy or hypersensitivity to eggs, egg proteins, latex, diphtheria toxoid, or any other components of Vaxigrip and Menactra 5. Known chronic medical condition that in the judgment of the investigator could compromise the evaluation of the study vaccine or puts the subject at risk 6. Known active infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C 7. Any of the following complications with the ongoing pregnancy: preterm labor (with cervical change), placental abruption, premature rupture of membranes, known major congenital anomaly, or preeclampsia. 8. Acute illness and/or an oral temperature greater than or equal to 37.8 degrees C, within 72 hours of vaccination (This may result in a temporary delay of vaccination) 9. Receipt of any other vaccine, excluding tetanus toxoid, within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines and meningococcal A conjugate vaccine (MenAfriVac)) prior to vaccination in this study 10. Woman who intends to travel out of the study area for the 40 days after delivery 11. Receipt of immunoglobulins and/or any blood products within 30 days prior to the administration of study vaccines 12. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within 90 days prior to administration of study vaccines (including systemic corticosteroids, e.g. prednisone or equivalent > 0.5 mg/kg/day; topical and inhaled steroids are allowed) 13. Any condition which in the opinion of the investigator might compromise the well-being of the participant or compliance with study procedures or interfere with the evaluation of the study vaccines
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Influenza for RA Subjects Male or non-pregnant female between the ages of 18 and 64 years, inclusive, who has stable RA and has received TNFi therapy during the previous 3 months Female subjects: for the 30 days prior to enrollment through 30 days following receipt of TIV or HTIV vaccine must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, barrier methods (such as a condom or diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices). Adherence to contraceptive method will be captured on the appropriate case report form (CRF) In good health, as determined by vital signs (see toxicity table in section 9.2.1.1), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and physical examination Intend to be available through 6 months following receipt of vaccine Able to understand and comply with planned study procedures Provide written informed consent prior to initiation of any study procedures. for Healthy Subjects Male or non-pregnant female between the ages of 18 and 64 years, inclusive Female subjects: for the 30 days prior to enrollment through 30 days following receipt of TIV or HTIV vaccine must fulfill one of the following: (i) she is not able to bear children because she has been surgically sterilized (tubal ligation or hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she agrees to practice effective methods of contraception including, but not limited to, abstinence, barrier methods (such as a condom or diaphragm) used with a spermicide, birth control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs (intrauterine devices). Adherence to contraceptive method will be captured on the appropriate case report form (CRF) In good health, as determined by vital signs (see toxicity table in section 9.2.1.1), medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and physical examination for all Subjects For subjects enrolled after July 2012: Enrolled in this study during the 2011-2012 flu season Has received the seasonal influenza vaccine for the current season. For subjects enrolling between October 2011 and February 2012, this is the 2011-2012 seasonal influenza vaccine. For subjects enrolling after July 2012, this is the 2012-2013 seasonal influenza vaccine Has a known allergy to eggs, egg proteins or other components in the vaccines (i.e. formaldehyde, gelatin sodium phosphate, sodium chloride, octylphenol ethoxylate) Has a known or suspected latex allergy or sensitivity Has a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential as defined in criterion 2), or women who are breastfeeding Has a history of severe reactions following immunization with contemporary influenza virus vaccines Has an active neoplastic disease or a history of any hematologic malignancy (cancers of blood or bone marrow) or current bleeding or blood clotting disorder For "healthy volunteer" (without RA) subjects: Long term (at least 14 days of prednisone 2 mg/kg or equivalent other glucocorticoid) use of oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.) Has a diagnosis of a current and uncontrolled major psychiatric disorder
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-60.0, Hypogonadotropic Hypogonadism Healthy Postmenopausal Women Agonadism A. Healthy Subjects All healthy subjects will meet the following normal puberty with respect to onset and pace no difficulty with blood draws no prescription medications for at least 2 months with the exception of asthma medication (albuterol only), hypercholesterolemia medication and psychiatric medication no illicit drug use or excessive alcohol consumption (>10 drinks/week) no history of a medication reaction requiring emergency medical care normal physical exam and laboratory studies within protocol reference ranges. Additional based on subject population: 1. Healthy Men between 21 and 40 years old normal erectile and ejaculatory function, no history of reproductive disorders testicular volume >15 ml. 2. Healthy women
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Flu Employee at partner corporation Employee already received a flu shot this season
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Myeloma Clonal bone marrow plasma cells >/=10% or biopsy-proven bony or extramedullary plasmacytoma and any one or more of the following myeloma defining events: Myeloma defining events: Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically: Hypercalcaemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal or >2.75 mmol/L (>11 mg/dL) Renal insufficiency: creatinine clearance <40 mL per min† or serum creatinine >177 μmol/L (>2 mg/dL)Anaemia: haemoglobin value of >20 g/L below the lower limit of normal, or a haemoglobin value <100 g/L Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET-CT Any one or more of the following biomarkers of malignancy: Clonal bone marrow plasma cell percentage ≥60% Involved:uninvolved serum free light chain ratio§ ≥100>1 focal lesions on MRI studies. 2. Continue of 1: If bone marrow has less than 10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement. Patient must not have been previously treated with any prior systemic therapy for the treatment of active multiple myeloma. o Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 320 mg of dexamethasone in a 2 week period). o Bisphosphonates are permitted. Prior Therapy for smoldering myeloma is permitted. 3. Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. One week must have lapsed since last date of radiotherapy, which is recommended to be a limited field and from start of protocol therapy. . Patients who require concurrent radiotherapy should have entry to the protocol deferred until the radiotherapy is completed and one week have passed since the last date of therapy and from start of protocol therapy. . 4. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 5. Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10-14 days prior to therapy and repeated again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. 6. Age > / = 18 years at the time of signing Informed Consent. 7. Patients must meet the following laboratory absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (growth factors not permitted to make eligible) , Hemoglobin >/= 9 g/dl (transfusion permitted) , Platelets >/= 100 x 10^9/L , Aspartate transaminase (AST) and Alanine transaminase (ALT) </= 2.5 x upper limits of normal (ULN) , Serum bilirubin </= 1.5 x ULN 8. Baseline Multi Gated Acquisition Scan (MUGA) or echocardiogram (ECHO) must demonstrate LVEF >/= 50% 9. All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. 10. Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 2 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin) Patient has >/=Grade 2 peripheral neuropathy on clinical examination within 28 days of signing consent. 2. Renal insufficiency Creatinine > 2.5 mg/dl 3. Myocardial infarction within 6 months prior to signing consent or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any Electrocardiograph (ECG) abnormality at screening has to be documented by the investigator as not medically relevant. 4. Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment. 5. Impaired cardiac function or clinically significant cardiac diseases, including any one of the following: History or presence of sustained ventricular tachyarrhythmia; Any history of ventricular fibrillation or torsade de pointes; Bradycardia defined as HR< 50 bpm. Patients with pacemakers are eligible if heart rate (HR) >/= 50 bpm. Screening ECG with a QTcF > 450 msec, Right bundle branch block + left anterior hemiblock (bifascicular block) , Patients with myocardial infarction or unstable angina </= 6 months prior to starting study drug , Other clinically significant heart disease (e.g., congestive heart failure (CHF) New York Heart Association class III or IV , uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen) 6. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat 7. Patients with diarrhea > Common Terminology for Adverse Events (CTCAE version 4) grade 2 at the time of signing consent 8. Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol 9. Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug 10. Female subject is pregnant or breast-feeding. 11. Hypersensitivity to acyclovir or similar anti-viral drug 12. Hypersensitivity to boron or mannitol, or compounds containing these components
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 20.0-49.0, Heavy Uterine Bleeding Uterine Fibroids Subject is a pre-menopausal female 20 to 49 years of age Subject has a diagnosis of uterine fibroids documented by a pelvic ultrasound assessed by a central reader and verification that a fibroid present met the following At least 1 fibroid with diameter ≥ 2 cm (longest diameter), or multiple small fibroids with a total uterine volume of ≥ 200 cm³ to ≤ 2,500 cm³ (approximately 22 weeks' gestation) as documented by a centrally read ultrasound Only intramural, submucosal non-pedunculated, and subserosal fibroids qualified subjects for enrollment (intracavitary pedunculated fibroids were exclusionary) Ultrasound procedures were performed during the Screening Period, and subjects were not randomized until the investigator reviewed the central reader results verifying the requirements Subject has a history of regular menstrual cycles between 24 to 35 days Subject has heavy uterine bleeding associated with uterine fibroids as evidenced by blood loss > 80 mL during 2 screening menstrual cycles, measured by the alkaline hematin method Subject has had a myomectomy, uterine artery embolization, or high intensity focused ultrasound for fibroid destruction within 1 year prior to randomization or any history of endometrial ablation Subject has a history of osteoporosis or other metabolic bone disease Subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes Subject has a history of clinically significant condition(s) including but not limited to Endometriosis Epilepsy or seizures Type 1 diabetes Any cancer (except basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, H5N1 Influenza All participants (vaccinees, household contacts, and intimate contacts) must meet all of the following 1. Age 18 to 49 years for vaccinees. Vaccinees may be >49 years of age at the time of booster vaccination. Age 18 to 65 years for household and intimate contacts. 2. Negative FDA-approved HIV test 3. Able to provide proof of identity to the acceptance of the Principal Investigator or designee during enrollment. 4. Available and willing to participate in follow-up visits and tests for the duration of the study, 5. Willing to have samples stored for future research. 6. Negative <=-HCG pregnancy test for females presumed to be of reproductive potential. 7. A female must meet one of the following 1. No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation. or 2. Participant agrees to be heterosexually inactive or consistently practice contraception at least 21 days prior to enrollment and 28 days following vaccination. Acceptable methods of contraception the following condoms, male or female, with a spermicide diaphragm or cervical cap with spermicide contraceptive pills, Norplant, or Depo-Provera male partner has previously undergone a vasectomy for which there is documentation intrauterine device 8. Male participants must agree to practice abstinence or effective birth control for at least 21 days prior to enrollment and during the first 28 days following vaccination. The following apply only to vaccinees and not to household or intimate contacts: 1. Willing to receive HIV test results and abide by NIH guidelines for partner notification of positive HIV results. 2. Physical examination and laboratory results without clinically significant findings within the 8 weeks prior to enrollment. 3. Willing to avoid vaccination other than the study agent for 30 days prior to and 30 days after administration of the Ad4-H5-Vtn vaccine. 4. Safety Laboratory within 8 weeks prior to enrollment Hematopoietic: White blood cell count and Lymphocyte count +/ the normal limits for the NIH Clinical Center Platelet count of least 125,000/mm3 Hemoglobin >11.2 g/dL for females and >13.0 g/dL for males A participant (vaccinees, household contacts, and intimate contacts) will be excluded if they have the following: 1. Any condition that, in the investigator's judgement, places the subject at undue risk by participating in the study. The following criterion applies to vaccinees and intimate contacts, but not to household contacts: 1. History of any prior disease or therapy which would affect immune or pulmonary function. 2. Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. 3. History of radiation therapy or cytotoxic/cancer chemotherapy. 4. History of insulin-dependent diabetes mellitus. 5. Immunodeficiency or autoimmune disease. 6. Acute infection or a recent (within 6 months) history of chronic infection suggestive of immunodeficiency. 7. Taking any medication which may affect immune function, except participants may be taking low doses of nonprescription strength (including e.g. ibuprofen or aspirin) or acetaminophen. 8. Chronic respiratory disorders including asthma, emphysema, interstitial lung disease, pulmonary hypertension, recurrent pneumonia, or recent or ongoing respiratory tract infection. If a respiratory disorder is transient, defer immunization but do not the participant. 9. Active Hepatitis B or C infection, as indicated by the presence of Hepatitis B antigen or Hepatitis C virus (i.e. Hepatitis B or C positive serology with the presence of virus antigen or DNA. Ongoing viral replication will be confirmed by a Hepatitis B antigen or Hepatitis C viral load). 10. Female of child-bearing potential who is breast-feeding or planning pregnancy during the 28 days following vaccination. The following apply only to vaccinees and not to household or intimate contacts: 1. Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with or serve as a contraindication to receipt of live virus vaccine, protocol adherence, or a participant s ability to give informed consent. 2. Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment. 3. Participants that live in the same house or apartment with any of the following will be excluded An individual under 18 years of age An immunocompromised or immunosuppressed individual An individual with chronic respiratory disease A woman who is currently pregnant or planning a pregnancy during the period of immunization 4. Healthcare worker who has direct contact with immunodeficient, unstable patients, or pediatric patients. 5. Participants caring for children <36 months of age. Potential vaccinees with any household or intimate contact who cares for children <36 months of age will also be excluded. 6. Receipt of any of the following Antiviral medications within 30 days prior to vaccination Blood products within 120 days prior to HIV screening Immunoglobulin within 60 days prior to HIV screening Investigational research drugs or any other investigational agent that in the judgement of the PI might interact with the study vaccine within 30 days prior to initial study vaccine administration
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Pneumococcal Infections Pneumococcal Pneumonia Aged 18 to 50 years on the day of Healthy, as determined by medical history and clinical examination Informed consent obtained Able to attend all scheduled visits and to comply with all trial procedures For a woman, inability to bear a child or negative urine pregnancy test at each vaccination visit For a woman of child-bearing potential: use of two medically acceptable, effective methods of contraception (oral contraceptive, intrauterine device, diaphragm, spermicide, or condom) or abstinence throughout the study participation starting at least 30 days prior to the first vaccination up to at least 30 days after the last vaccination Serious chronic disease (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system) that could interfere with trial conduct or and/or raise a safety concern For a woman, breast-feeding Participation in another clinical trial in the 30 days preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances Current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures Blood or blood-derived products received in the past 3 months Any vaccination in the 30 days preceding the first trial vaccination Vaccination planned in the 30 days following any trial vaccination
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 14.0-60.0, Traumatic Brain Injury Mild traumatic brain injury Glasgow Coma Scale (GCS) of 14-15 Requires emergency neurosurgery procedures Physical status ASA I-II Onset of trauma < 9 hours Multiple injury Pregnancy/lactation History of alcohol or barbiturate consumption prior to the injury
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Influenza Human Employee of Express Scripts Eligible to receive a flu shot at Express Scripts Over 18 years of age Children Non Express Scripts employees
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Contraception Women at risk of pregnancy and seeking contraception based on approved prescribing information in India Presence or history of venous thrombosis, with or without pulmonary embolism Presence or history of arterial thrombosis (e.g. cerebrovascular accident, myocardial infarction) or prodromi of a thrombosis (e.g. angina pectoris or transient ischemic attack) Known predisposition for venous or arterial thrombosis, with or without hereditary involvement such as Activated Protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia and antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant) History of migraine with focal neurological symptoms Diabetes mellitus with vascular involvement The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis (at the discretion of the doctors) Pancreatitis or a history thereof if associated with severe hypertriglyceridemia Presence or history of severe hepatic disease as long as liver function values have not returned to normal Presence or history of liver tumors (benign or malignant)
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Recurrent Aphthous Stomatitis The volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month already using an SLS-free dentifrice taking medications affecting oral ulcers (e.g., corticosteroids) having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.) having allergies to food or medications being pregnant
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Healthy Is the individual a healthy, normal adult man or woman who volunteers to participate? Is s/he within 18 to 45 years of age, inclusive? Is his/her BMI between 19 and 30 inclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse with a non-sterile male partner, or by the use one of the following methods: diaphragm + spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine contraceptive device or hormonal contraceptives (at least 4 week prior to dosing) or has she been surgically sterile or post-menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has s/he provided written informed consent? Does the individual have a history or allergy or hypersensitivity to desloratadine or pseudoephedrine, milk or eggs? Does s/he have clinically significant laboratory abnormalities that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal disease that would interfere with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history (within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or a positive HIV-I, or hepatitis B or C screen, or a positive pregnancy test? Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the last blood sample has been taken in each study period? Has s/he used any prescription drug, other than hormonal contraceptives, during the 14 day period prior to study initiation, or any OTC drug during the 72 hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications, other than hormonal contraceptives, during the study?
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-75.0, Irregular Menstrual Cycle Women aged 18 years or older Suffering from irregular menstrual cycle for at least 3 months and for whom the physician decides to prescribe Duphaston, in accordance with locally approved package insert Patients willing to sign written authorization to provide data for the study Patients having known hypersensitivity to the active ingredient or excipients Patients having known or suspected progesterone-dependent neoplasms Patients having vaginal bleeding of unknown etiology Patients taking oral contraceptives Pregnant and lactating patients Any other condition that precludes use of Duphaston in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with history of liver disease, porphyria or depression) Patients not willing to sign written authorization for data release consent form
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Myeloma 1. Multiple Myeloma Diagnosis: Subject was previously diagnosed with multiple myeloma by the International Myeloma Foundation 2003 Diagnostic IMF Diagnostic ALL 3 1. Monoclonal plasma cells in the bone marrow > 10% and/or presence of a biopsy-proven plasmacytoma 2. Monoclonal protein present in the serum and/or urine * 3. Myeloma-related organ dysfunction (1 or more) ** ; [C] Calcium elevation in the blood S. Calcium >10.5 mg/l or upper limit of normal ; [R] Renal insufficiency ; [A] Anemia Hemoglobin < 10 g/dl or 2 g < normal ; [B] Lytic bone lesions or osteoporosis *** 2. Continuation from # 1: *If no monoclonal protein is detected (non-secretory disease), then > 30% monoclonal bone marrow plasma cells and/or a biopsy-proven plasmacytoma required ** A variety of other types of end organ dysfunctions can occasionally occur and lead to a need for therapy. Such dysfunction is sufficient to support classification of myeloma if proven to be myeloma related. *** If a solitary (biopsy-proven) plasmacytoma or osteoporosis alone (without fractures) are the sole defining then > 30% plasma cells are required in the bone marrow. 3. Patient must not have been previously treated with any prior systemic therapy for the treatment of multiple myeloma. Prior treatment of hypercalcemia or spinal cord compression with corticosteroids does not disqualify the patient (the dose should not exceed the equivalent of 160 mg of dexamethasone in a 2 week period). Bisphosphonates are permitted 4. Patients treated with local radiotherapy with or without concomitant exposure to steroids, for pain control or management of cord/nerve root compression, are eligible. One week must have lapsed since last date of radiotherapy, which is recommended to be a limited field. Patients who require concurrent radiotherapy should have start of the protocol therapy (Cycle 1 Day 1) deferred until the radiotherapy is completed and one week have passed since the last date of therapy. 5. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. 6. Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 milli-International unit (mIU)/mL 10 days prior to therapy and repeated again within 24 hours of prescribing lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. 7. Age >/= 18 years at the time of signing Informed Consent. 8. All necessary baseline studies for determining must be obtained within 28 days prior to enrollment. 9. Subject has a Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 10. All study participants must be registered into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist. 11. Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). 12. Subject must be able to adhere to the study visit schedule and other protocol requirements Patient has >/=Grade 2 peripheral neuropathy on clinical examination within 14 days before enrollment. 2. Renal insufficiency (Creatinine Clearance <30 mL/min by Cockcroft -Gault formula). 3. Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count >/= 50,000 cells/mm^3). 4. Subjects with an absolute neutrophil count (ANC) < 1000 cells/mm^3. Growth factors may not be used to meet ANC criteria. 5. Total bilirubin > 1.5 mg/dL 6. Subjects with a hemoglobin < 8.0 g/dL (Transfusion are permitted). 7. AST (SGOT and ALT (SGPT) >/= 2 x upper limit of normal (ULN) 8. Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant. 9. Clinically relevant active infection requiring intravenous antibiotics 10. Serious co-morbid medical conditions such as uncontrolled chronic obstructive or chronic restrictive pulmonary disease, and cirrhosis. 11. Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the subject at unacceptable risk if he/she were to participate in the study. 12. Female subject is pregnant or breast-feeding. 13. Serious medical or psychiatric illness likely to interfere with participation in this clinical study. 14. Uncontrolled diabetes mellitus (Fasting Blood Sugar > 400 mg/dl despite medical treatment) 15. Hypersensitivity to acyclovir or similar anti-viral drug 16. Known history of POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes). 17. Patients with known history of HIV, Hep B and C. 18. Hypersensitivity to boron or mannitol, or compounds containing these components 19. Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study treatment
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 27.0-38.0, Polycystic Ovary Syndrome diagnosis of PCOS irregular menstrual cycle (> than 28-30 days) normal uterine cavity body mass index of 20 to 26 Kg/m2 first IVF treatment presence of tubal, uterine, genetics and male causes of infertility diagnosis of cancer hormonal treatment in the last six months
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 9.0-45.0, Human Papillomavirus Healthy female between, and including, 9 and 45 years of age at the time of the first vaccination Provide legal identification for for the sake of recruitment Be able to understand and sign informed consent prior to enrollment (For subjects below the legal age of consent, informed consent must be signed by parent(s)/legal guardian(s) in addition) Subject must be not pregnant at the enrollment and agree to using adequate contraceptive precautions within 7 months History of cervical cancer History of severe allergic reaction requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock) History of allergic to vaccine, or to any ingredient of vaccine History of epilepsy, seizures or convulsions, or family history of mental illness Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose History of asthma, thyroidectomy, angioneurotic edema, diabetes or malignant Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder Acute disease or chronic disease acute exacerbation 7 days prior to vaccination Administration of immunoglobulins and/or any blood products within 3 months, or administration of any live attenuated vaccine within 28 days, or administration of any subunit or inactivated vaccines within 14 days
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-80.0, Aging Males and Females between 18 years old Males and Females between 60 years old cardiovascular and/or microvascular disease blood clotting disorder pregnant lady current smoker (or regularly smoked within last year) a history of an adverse reaction to cold taking medications known to effect the autonomic nervous system
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Healthy, no Evidence of Disease Healthy individuals seen at the Employee Health Clinic who will be eligible to receive influenza vaccine Willingness to comply with study expectations subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure ONLY Willing to suspend use of any other vitamin D supplementation during the 3 month treatment interval; if currently using > 2,000 IU/day of vitamin D supplementation, must suspend use 30 days prior to enrollment -not RPCI employee
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-65.0, Diabetes Effects of Liraglutide Administration on Brain Activity Weight Loss Hunger Subjects will be men and women between the ages of 18 and 65. The following table list for each group (lean diabetic and obese diabetic). Subjects must meet either HbA1c or fasting plasma glucose (FPG) criteria. Lean diabetic: BMI: 18-25 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other On dietary modification and/or metformin Obese diabetic: BMI: >27 kg/m2 HbA1c: < 8.9% Fasting plasma glucose: <250 mg/dL Other On dietary modification and/or metformin Additionally, women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child Uncontrolled diabetes (HbA1c>8.9%, or FPG>250 mg/dL) 2. Women who are breastfeeding, pregnant, or wanting to become pregnant. 3. Women using IUD 4. Any change in the dosage of hormonal contraceptive medications (birth control pills, implanon). Subjects should remain on same medication/ same dose during the time of the entire study. 5. Moderate (creatinine clearance of 30-59 ml/min) and severe renal impairment (creatinine clearance below 30 ml/min) and end-stage renal disease 6. Moderate, or severe hepatic impairment 7. Hypersensitivity to the active substance or any of the excipients in liraglutide 8. History of diabetic ketoacidosis 9. Congestive heart failure 10. Inflammatory conditions like inflammatory bowel disease, Rheumatoid arthritis etc 11. Gastroparesis 12. Pancreatitis 13. Gallstones as they may cause increased risk of pancreatitis 14. Alcohol consumption the maximum quantity for men is 140g-210g per week. For women, the range is 84g-140g per week or drinking as consuming no more than two drinks a day for men and one for women. Alcohol can cause increased risk of pancreatitis and hypoglycemia. 15. Untreated thyroid disease like hypothyroidism or hyperthyroidism 16. Subjects taking the following medications: warfarin, steroids (inhaled or systemic due to reduced hypoglycemic effect), and subjects on other hormones (LHRH analogs etc). 17. Subjects on any oral anti-diabetic agent except metformin 18. Personal or family history of MEN II or medullary thyroid cancer 19. Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neuron or biostimulators, electronic infusion pumps, etc.) 20. Subjects with any type of metallic implant that could potentially be displaced or damaged during MRI, such as aneurysm clips, metallic skull plates, surgical implants etc. or metal containing tattoos 21. Anxiety and/or claustrophobia 22. Uncontrolled cardiac impairment, circulatory impairment, or inability to perspire (poor thermoregulatory function) 23. Significant sensory or motor impairment 24. Epilepsy, particularly photo-sensitive epilepsy, which may place the individual at a higher risk for adverse events during fMRI scanning with visual stimulation 25. Subjects with neurological problems which may interfere with or complicate testing (e.g. presence of titubation) 26. Body weight above the limitation of the MRI scanning table (330lbs/150 Kg) or body dimensions that could difficult the performance of the scan. 27. Subjects who cannot adhere to the experimental protocol for any reason 28. Anemia with Hgb less than 10 29. Uncontrolled infectious diseases (e.g. HIV, hepatitis, chronic infections etc) 30. Any uncontrolled endocrine condition, e.g Cushing's, Acromegaly, etc 31. Any cancers or lymphoma 32. Eating disorders like anorexia, bulimia 33. Severe hypertriglyceridemia (triglycerides >500 mg/dl) 34. Weight loss surgery or gastrectomy 35. Any changes in medications that affect brain function, e.g. anti-depressants, anti-psychotics, anti-anxiety, anti-seizure medications, antihypertensives etc (subjects should remain on same medication/ same dose during the time of the entire study). 36. Irregular periods, defined as cycle length less than 22 days or more than 40 days. 37. Any change in smoking status. 38. Vegetarians as food images presented will numerous non-vegetarian items and thus will not be appealing as high calorie food items
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 20.0-999.0, Lactation age >20 at the time of delivery singleton pregnancy and <2 prior pregnancies that were >20 weeks gestation maternal rheumatologic disorders maternal anorexia nervosa maternal endocrinologic disorders medications known to affect bone density such as corticosteroids, thyroid hormone use, anticonvulsant therapy, bisphosphonates, long-term GnRH agonists use and calcitonin Subsequent pregnancy during the study
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Mucositis Patient has oral mucositis pain that is grade 3 or 4 according to the World Health Organization (WHO) Oral Mucositis Scale Patient has received at least one prior chemotherapy or radiation treatment Patient is at least 18 years old Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-45.0, Influenza Healthy status confirmed by History, Physical Exam and blood work through the CHI Screening Protocol. 2. Age 21 years to 45 years 3. Able to comprehend the investigational nature of the protocol and provide informed consent 4. Must be willing to use effective birth control for one month before, during and for two months after the last vaccination Severe allergies to eggs or their products, chicken proteins or to any component of the influenza antigen preparation. 2. Recipient of AS03 vaccine at any time in the past 3. Recipient of the seasonal influenza vaccine within the past 3 months. 4. Prior severe reactions to vaccines, including influenza vaccines (e.g. anaphylaxis, angioedema or urticaria) 5. Participation on any blood collection or blood donation procedure during study that will bring the total blood draw >550ml over 8 weeks 6. Current pregnancy (women of child bearing potential must have a negative serum pregnancy test done on screening within 1 week of protocol accrual) 7. Currently breast-feeding 8. History of Guillain Barre syndrome 9. Acute illness with patient reported temperature of 38 (Infinite)C or greater within 3 days prior to the proposed time of administration. 10. Any history or presence of serious illness, bleeding disorders or autoimmune disorders, or planned surgeries. 11. Weight less than 50 kg (110 pounds) 12. History of hepatitis or liver disease. 13. Subjects receiving immunosuppressive therapy. 14. Presence of HLA DQB1*06:02, the narcolepsy risk associated allele
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Scar Ages 50 (Both Male & Female) Non-smoker having quit at least 3 months prior to enrollment Non-diabetic Non-pregnant or non-breastfeeding verbal assent If a female subject of childbearing age misses her menstrual period after the start of the study, she will inform the investigators and be given a pregnancy test to ensure, for safety reasons, that she is not pregnant. If she is pregnant, she will discontinue participation in the study No current use of OTC medications or other form of supplements containing vitamin-E Diabetes or HIV diagnosis Alcohol or drug abuse unable to provide informed consent Therapeutically anti-coagulated Prisoner Currently prescribed immunosuppressant medication
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.25-0.417, Meningitis Influenza Healthy subjects aged 3 to 5 months, normal intelligence The subjects' guardians are able to understand and sign the informed consent Healthy subjects confirmed by medical history questioning, physical examination and clinical decision and in accordance with vaccination requirements of the investigational vaccine Subjects who can comply with the requirements of the clinical trial program according to the researcher's views Subjects who have never received group A, C polysaccharide meningococcal vaccine and type b haemophilus Influenzal vaccine Subjects with temperature<=37°C on axillary setting for the first vaccination Subject who has a medical history of Meningitis Subject who has a medical history of any of the following: allergies, seizures, epilepsy, encephalopathy history and so on Subject who is allergic with tetanus toxoid components Subject suffering from thrombocytopenia or other coagulation disorder may lead to contraindication to intramuscular injection Subject who has a history of allergic reactions Any known immunological dysfunction Had received gamma globulin or immune globulin, in the past two weeks Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws Any acute infections in last 7 days
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 19.0-49.0, Influenza, Human Males and females in good general health, 19 to 49 years of age. 2. Subjects must provide written informed consent. 3. Subjects must be willing to participate through study completion. 4. Have not been vaccinated for influenza virus in the current season or had a known influenza virus infection in the current season 5. Subjects must be willing to undergo nasal washes and provide parotid saliva, urine and blood samples per protocol for safety and immunogenicity analyses. 6. Females of childbearing potential must have a negative urine pregnancy test. 7. A female volunteer must Agree to consistently use effective contraception from at least 21 days prior to enrollment through the Day 84 clinic visit for sexual activity that could lead to pregnancy Effective contraception is defined as using any of the following methods condoms (male or female) with or without spermicide diaphragm or cervical cap with spermicide intrauterine device (IUD) hormonal contraception, or successful vasectomy in the male partner (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post-vasectomy) Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, bilateral oophorectomy, or tubal ligation Or be sexually abstinent Pregnant or lactating women. 2. Any flu/cold, or respiratory tract symptoms and/or fever greater than 101 ºF in the 3 days prior to study enrollment and/or initial vaccination. 3. Any intranasal medication administered in the 10 days prior to study enrollment and/or initial vaccination. 4. History of Bell's palsy, significant cardiac history including history of arrhythmias, coagulopathy, history of cardiovascular accident, bone marrow diseases, known or suspected, autoimmune diseases (such as but not limited to psoriasis, rheumatoid arthritis, hyperthyroidism, hypothyroidism, vasculitis, Raynaud's phenomenon, rhabdomyolysis and myositis, nephritis, systemic lupus erythematosus and sarcoidosis, hemolytic anemia) and any history of malignancy. 5. History of chronic rhinitis or presence of pre-existing nasal septal defect, nasal polyps or other gross abnormalities that might impact vaccine administration, or any previous nasal cautery or significant surgery for nasal septal defects. 6. Any regular past or current use of intranasal illicit drugs, or a history of intravenous illicit drug use. 7. Asthma, or other chronic respiratory disorders, of any severity, even if mild. 8. Reactive HBVsAg or reactive HCV Ab. 9. HIV positive by history or by screening test. 10. History of alcohol or other substance abuse, or history of depression or suicidal ideation, or a suicide attempt within two (2) years of screening. A score of 5 or greater on the PHQ-9 at Baseline indicates symptoms of depression and will subject. A score of greater than zero on question nine (9) of the PHQ-9 at Baseline indicates suicidal ideation and will subject. 11. Immunosuppressed, altered or compromised immune status as a consequence of disease (i.e. asplenia, recurrent severe infections) or chronic treatment (more than 14 days) with systemic corticosteroids (including inhaled or intranasally-administered drugs), alkylating drugs, anti-metabolites, radiation, or other immunosuppressive therapies within the preceding 6 months. 12. Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment. 13. Receipt of an influenza vaccine within the past 6 months. 14. Receipt of any vaccine in the past 30 days. 15. Receipt of any investigational drug in the past 30 days. 16. Known diabetes mellitus. 17. History of anaphylaxis, Guillain-Barré Syndrome, or angioedema. 18. Blood pressure > 140/90 (either or both values) at screening or enrollment. 19. Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a participant's ability to give informed consent. 20. History of taking antiviral drugs active against influenza A and/or B in last 72 hours before FluMist® administration. 21. Hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine, or life threatening reactions to previous influenza vaccinations. 22. Clinically significant abnormality on screening EKG
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, HIV Dementia Men and women 18 years of age or older and less than 65 years of age. Able to read and understand English. HIV infected on stable ART regimen for 5 months or greater, and not likely to change regimen for the duration of the study. Significant dementia but able to give consent (International HIV Dementia Scale score <10). Significant cognitive slowing on screening, defined as 1 SD below normal (t-score >60) on the Conner's CPT-II reaction time test. Beck Depression Inventory score <16. Documented HIV-1 RNA PCR <50 copies/mL and documented CD4 count >200 within 3 months of entry visit. Baseline CBC and chemistry panel Grade 1 or normal. For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within 24 months prior to study entry), or women who have not undergone surgical sterilization, specifically hysterectomy or bilateral oophorectomy or tubal ligation) will require a negative serum or urine pregnancy test within 48 hours prior to entry. NOTE: Subject reported history is considered acceptable documentation of hysterectomy, bilateral oophorectomy, tubal ligation, tubal micro-inserts, menopause, and vasectomy/azoospermia. All subjects must agree not to participate in the conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must use at least two reliable methods of contraception, (condoms, without a spermicidal agent; a diaphragm or cervical cap without spermicide; an IUD; or hormone-based contraceptive), for 2 weeks before study treatment, while receiving study treatment, and for 6 weeks after receiving study treatment. Ability and willingness of subject to provide informed consent Inability to give informed consent. No proxy consent allowed. Uncontrolled hypertension (SBP >140 and DBP >90 at screening and baseline). Untreated hypogonadism, hypothyroidism or hyperthyroidism. Initiation of antidepressants, thyroid medication or anabolic steroids within 6 weeks of screening visit. Pregnancy or breast feeding. Clinically significant EKG abnormalities at screening. History of coronary artery disease, atherosclerotic disease, left ventricular hypertrophy, cardiomegaly, syncope, congestive heart failure, myocardial infarction, pacemaker, clinically significant arrhythmia, angina, history of treatment for arrhythmia. Brain related opportunistic infections, stroke, intracranial lesions/disease, or meningitis. History of epilepsy. Untreated depression. Uncontrolled diabetes (glucose <70 or >200 at screening). Use of interferon or ribavirin during study and for 1 month prior to screening. History of bipolar disorder, Alzheimer's dementia, ALS, Parkinson's disease or other medical dementias other than HIV-related. History of schizophrenia, mania or other serious mental illness. History of methylphenidate allergy. Other serious concurrent medical illness other than HIV. History of radiation therapy to the brain or brain injury. History of crystal methamphetamine, cocaine, LSD use or other recreational substance use other than marijuana within the 12 months prior to screening and for the duration of the study. Plan to use marijuana or marinol during the entire study duration and one month prior to screening visit. Plan to drink 7 or more alcoholic drinks per week during the 4 weeks prior to screen visit and for the duration of the study. History of alcohol dependence, alcohol abuse, cocaine addiction, crystal methamphetamine addiction or other recreational drug addiction or treatment for addiction or dependence within 5 years of screening visit. If subject is using prescription narcotics, should be on a stable dose for at least 1 month prior to screening and throughout the study. Previous use of Concerta™, Ritalin™, atomexitine or Adderall™ or other psychostimulants (e.g. modafinil, armodafinil) for 3 months prior to screening visit and for duration of the study. History of tic disorders in the past 3 months or any history of Tourette's syndrome. Greater than 10% below ideal body weight (IBW for men = 50 kg + 2.3 kg per inch over 5 feet of height, and IBW for women = 45.5 kg + 2.3 kg per inch over 5 feet of height) Uncontrolled migraine headaches. History of short gut syndrome, Meckel's diverticulum, or cystic fibrosis. Family history of sudden cardiac death in a young relative. History of fainting with exercise. History of attention deficit disorder will be excluded, defined as a score greater than 6 on the Childhood ADHD Symptoms Scale. -
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-72.0, Hypothermia Newborn Estimated gestational age 37 weeks and greater Birth weight greater than 2,500gms Delivery in the hospital Infant admitted to the NICU Birth weight less than 2,500gms Abdominal wall defect or myelomeningocele Major congenital anomalies Blistering skin disorder
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Recurrent Oral Cavity Adenoid Cystic Carcinoma Recurrent Salivary Gland Carcinoma Salivary Gland Adenoid Cystic Carcinoma Stage IVA Major Salivary Gland Cancer AJCC v7 Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7 Stage IVB Major Salivary Gland Cancer AJCC v7 Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7 Stage IVC Major Salivary Gland Cancer AJCC v7 Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7 Patients must have pathologically confirmed adenoid cystic carcinoma; confirmation will be performed locally at each participating institution; cancers arising from non-salivary gland primary sites are allowed Patients must have measurable disease, as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2.0 cm with conventional techniques or as >= 1.0 cm with spiral computed tomography (CT) scan; to be considered pathologically enlarged and measurable, a lymph node must be > 1.5 cm in short axis when assessed by CT scan (CT scan slice-thickness recommended to be no greater than 5 mm) Patients must have locally advanced and/or recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy Patients must have increasing disease, defined as the presence of new or progressive lesion(s) on CT/magnetic resonance imaging (MRI) within 6 months prior to study enrollment and/or new/worsening disease-related symptoms; NOTE: this increase in disease is to be determined in the oncologist's best judgment and does not have to meet Response Evaluation in Solid Tumors (RECIST) Chemotherapy and radiation therapy must be completed at least 4 weeks prior to registration; if the last regimen included Carmustine (BCNU) or mitomycin C, it must be completed at least 6 weeks prior to registration; NOTE: any number of prior chemotherapy regimens is allowed, including no prior treatment Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (equivalent to Karnofsky >= 50%) Leukocytes >= 3,000/mm^3 Absolute neutrophil count >= 1,000/mm^3 Platelets >= 75,000/mm^3 Total bilirubin =< institutional upper limit of normal (ULN) Patients who have received prior treatment with phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PI3K), v-akt murine thymoma viral oncogene homolog 1 (Akt), or mechanistic target of rapamycin (serine/threonine kinase) (mTOR) inhibitors for recurrent/metastatic ACC Patients who are receiving any other investigational agents Patients with known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to MK-2206 or other agents used in the study Patients receiving any medications or substances that are major inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP450 3A4) Diabetic patients with glycated hemoglobin (HbA1c) levels of greater than 8%; NOTE: preclinical studies demonstrated the potential of MK-2206 for induction of hyperglycemia in all preclinical species tested; patients with diabetes or at risk for hyperglycemia should not be excluded from trials with MK-2206, but the hyperglycemia should be well controlled before the patient enters the trial Cardiovascular baseline Fridericia corrected QT (QTcF) > 450 msec (male) or QTcF > 470 msec (female) will patients from entry on study; NOTE: medications that may cause QTc interval prolongation should be avoided by patients entering on trial Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements Pregnant women; NOTE: women of child-bearing potential must have a negative serum or urine pregnancy test within 7 days prior to registration 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
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-80.0, Allergies Twin participants ages 0 to 80 years who are with or without allergy disease Patients with special risks attendant to venipuncture will be excluded
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-65.0, Smoking Healthy female smokers ages 18 Read and write English Regularly smoke 5 or more cigarettes a day Sedentary, or not exercising greater than 20 minutes of vigorous exercise more than once a week or greater than 30 minutes of moderate exercise 2 times per week known history of cardiovascular pulmonary or metabolic disease such as coronary artery disease, stroke, hypertension, chronic bronchitis, asthma, emphysema, and diabetes Any musculoskeletal problems that would limit exercise training such as knee or hip osteoarthritis or any other serious medical condition that might make exercise unsafe or unwise The current use of smokeless tobacco, nicotine replacement therapy or other smoking cessation treatment, and currently using prescription medication that might impair exercise performance or tolerance, specifically beta-blockers or medications used for the treatment of hypertension Pregnant or planning to become pregnant within the next 12 months Women hospitalized for a psychiatric disorder Receiving treatment for bipolar disorder or schizophrenia Current alcohol abuse or psychological problems when quitting in the past that required treatment
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-40.0, Obesity Healthy females between the ages of 18-40 (inclusive) BMI > 27 kg/m² Regular menstrual cycle (28 ± 4 days with a maximum of 4 days within-subject variation in menstrual cycle duration Weight stable (within ± 3-kg) 2 months prior to study Must use barrier contraception (e.g. male/female condom) for the study's duration Must be willing to follow the prescribed diet/exercise plan for the study's duration On hormonal contraceptives (IUD are allowed) or any other daily use of medications which can make the subject unsuitable for in the study Any significant health problem (history of cancer, HIV/AIDS, Diabetes, cardiovascular disease, untreated hypothyroidism, etc.) Restrictions against participating in cardiovascular exercise and strength training Any condition, which in the opinion of the investigator makes the subject unsuitable for in the study Women who are pregnant,lactating, or planning to become pregnant during the study period
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 20.0-75.0, Infection Admission to Samsung Medical Center MICU and general wards for infectious diseases and hematology division Patients with SIRS (systemic inflammatory response syndrome) Intravenous vancomycin therapy deemed necessary Age less than 20 years Age more than 75 years Current renal insufficiency defined as estimated Glomerular filtration rate < 50mg/min/1.73 m2 by MDRD equation History of adverse events to vancomycin 5. Pregnant woman
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 35.0-55.0, Healthy Volunteer Healthy male volunteers, 35 to 55 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology and urinalysis A body mass index (BMI) between 18 to 30 kg/m2 inclusive Male volunteers and their partners of childbearing potential must use 2 methods of contraception, one of which must be a barrier method for the duration of the study and for 90 days after the last dose Able to participate and willing to give written informed consent and to comply with the study restrictions Non-smokers or have not smoked since at least 3 months prior to screening If capable of reproduction, unwilling to use an effective form of contraception Suspicion of regular consumption of drug of abuse and/or positive drug or alcohol screen Infection with hepatitis B, hepatitis C, or human immunodeficiency virus 1 and 2 Systolic blood pressure greater than 140 or less than 90 mm Hg, and diastolic blood pressure greater than 90 or less than 50 mm Hg Resting pulse rate greater than 90 or less than 45 beats per minute Clinically significant abnormalities in laboratory test results Participation in an investigational drug or device study within 90 days prior to screening Donation of blood within 3 months prior to screening Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-60.0, Enhancement of Protective Antibody Response After Probiotic Consumption healthy male and female adult between 18 and 60 years old non menopausal female( with effective contraception) female non pregnant not wishing to be pregnat during the study capable to respect the protocol affialted to the social security system aggreeing to be registered in the national fileof volunteers food allergy( component of the experimental product vaccines) manifestation of allergy vaccinated against flu during the 2 previous winters Food allergy, allergy to one of the component of the experimental products or allergy to one of the component of the flu vaccine Subject displaying manifestation of allergy or being treated for these Subject vaccinated against flu during the 2 previous winter (winter 2009-2010 and winter 2010-2011) Subject who had symptoms evocating flu during the previous winter (winter 2010-2011) Subject immunodepressed Subject with immunomodulatory treatment
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-65.0, Recurrent Aphthous Stomatitis Both male and female aged 18 to 65 years old; 2. Patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days; 3. Fresh ulcers available with less than 72 hours eruption Hypersensitive to various medical agents; 2. Concurrent acute infectious disease; 3. Pregnancy or lactation; 4. Concurrent other immunology disorders; 5. Accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months; 6. Aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia; 7. Aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (NSAIDs) and anti-histamines; 8. Accepting anaesthetic therapy within 24 hours, or systemic antibiotics within 2 weeks, or other management for oral ulcers within 72 hours prior to the study; 9. Neoplasm patients; 10. Volunteers of other clinical trials on medical agents or toothpaste within one month
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-49.0, Influenza Male or female aged 18 years Give written informed consent Healthy, as determined by medical history, physical examination, vital signs, and clinical safety laboratory examinations Females should not be pregnant and not lactating and fulfill one of the following At least one year post-menopausal;Surgically sterile;Will use oral, implantable, transdermal or injectable contraceptives for 30 days prior to first vaccination and until 28 days after vaccination Willing to use another reliable form of contraception approved by the Investigator for study duration and until 28 days after vaccination Women of childbearing potential must have a negative urine pregnancy test within 24 hours preceding receipt of vaccination Comprehension of the study requirements, expressed availability for the required study period, and ability to attend scheduled visits Willing to receive the unlicensed (VAX161) vaccine given as an i.m. injection Willing to provide multiple blood specimens collected by venipuncture
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-42.0, Influenza, Human 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. For the inpatient component of the study, participants must be willing and able to remain within the Isolation Unit for the specified duration of confinement. For the outpatient component of the study, participants must be willing and able to make daily outpatient follow-up visits as specified by the protocol Willingness to participate in the study as evidenced by signing the informed consent document Female participants 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; or 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. Clinically significant alanine aminotransferase (ALT) levels, as determined by the Principal Investigator, 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 subject to understand and cooperate with the study protocol Previous enrollment in an H2 or H9 influenza vaccine trial or in any study of an avian influenza vaccine For the inpatient arm, seropositive to the H2N3 influenza A virus or the H9N2 influenza A virus (serum HAI titer >1:8). For the outpatient arm, seropositive to the H3N2 component of seasonal LAIV (serum hemagglutination inhibition [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 participating in the trial or would render the subject unable to comply with the protocol History of anaphylaxis
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-42.0, Infertility Fertile women 1. Age 18-42 years 2. Regular ovulatory menstrual cycle 3. Previous spontaneous pregnancy to term 4. No history of subfertility 5. No underlying medical condition or immunosuppression 6. No history of hormonal medication or pregnancy in past two months 7. Capable of giving informed consent to participate in study 2. Non fertile women a.Age 18-42 years b.Regular ovulatory menstrual cycle c.Difficulty conceiving for greater than 12 months e.No underlying medical condition or immunosuppression f.No history of hormonal medication in past two months g.Capable of giving informed consent to participate in study hormonal medication 2. pregnancy 3. not capable of giving consent 4. age <18 years or > 42 years 5. underlying medical condition
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Depressive Symptoms B-RICH Phase I, Pilot 1. Age 18 or older 2. Endorse one item on the PHQ-2 3. Able to be contacted by phone 4. Able to participate in the six, weekly 90-120 minute sessions of the Resiliency Classes 5. English or Spanish speaker B-RICH, Phase I Pilot Under age 18 years 2. Endorse no items on PHQ-2 screener 3. PHQ-8 score of 15 or greater on the baseline interview 3) Unable to be contacted by phone 4) Unable to attend the weekly resiliency classes B-RICH Phase II, Randomized Trial 1. Age 18 or older 2. Endorse one of the first two items on the PHQ-8: "In the past two weeks, how often have you been bothered by 1) little interest or pleasure in doing things, 2) feeling down depressed or hopeless." 3. Able to be contacted by phone (voice or text message), e-mail, or Facebook. 4. Able to participate in the seven, weekly 90-120 minute sessions of the Resiliency Classes 5. English or Spanish speaker B-RICH Phase II, Randomized Trial Under age 18 years 2. PHQ-8 score of 20 or greater on the baseline interview 3. PHQ-8 score of 15 or greater and not currently in care and unwilling to get a referral for care 4. Currently homeless 5. Has a prior diagnosis of Bipolar Disorder 6. Has a prior diagnosis of Schizophrenia 7. Current alcohol and substance abuse 8. Unable to attend the weekly resiliency classes 9. Does not currently have a phone, an email address, or a Facebook profile
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 0.0-999.0, Human Papillomavirus Infection Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group) Not applicable
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 40.0-60.0, Obesity Healthy women aged 40 to 60 years 2. Are still experiencing regular menstrual cycles. 3. They must be willing to be randomized to placebo or GnRHAG therapy for 24 weeks 4. Be physically able to be randomized to participate in a programmed exercise training program. The investigators will consent up to 132 subjects with the aim of enrolling 22 in each of the 3 groups (placebo, GnRHAG, or GnRHAG+Exercise) irregular menstrual cycles defined as 2 or more missed cycles in the previous year serum FSH >25 mIU/mL measured during the first 5 days of the menstrual cycle on hormonal contraceptive or menopausal therapy positive pregnancy test intention to become pregnant or start hormonal contraceptive therapy during the period of study lactation known hypersensitivity to GnRH or leuprolide acetate score >16 on the CESD((Center for Epidemiologic Studies Depression Scale ) severe osteopenia or osteoporosis (i.e., proximal femur or lumbar spine t scores < -2.0) abnormal vaginal bleeding
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-64.0, Influenza Aged 18 through 64 years on the day of Informed consent form (ICF) has been signed and dated Able to attend all scheduled visits and to comply with all trial procedures Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination) Participation at the time of trial enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination Vaccination against influenza in the past 6 months Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 21.0-45.0, Characterize Gel Distribution in the Vagina Study Women's Sensory Perceptions and Preferences of Gel have had vaginal penetrative intercourse within the last 12 months have a regular menstrual cycle (between 24-35 days) and be able to record the day of onset of menses in a menstrual diary able to ambulate for 20 consecutive minutes after vaginal self-insertion of gel using an applicator willing to use a condom when engaging in sexual intercourse within 4 days before a study visit willing to avoid using any mechanical sex toy within 1 day before a study visit willing to use one of the following contraception methods if engaging in sexual intercourse during the length of participation in the study (hormonal contraceptive, tubal ligation, non-surgical procedure such as permanent transcervical sterilization, Fallopian tubes removed, partner vasectomy) able to provide informed consent pregnant, potentially pregnant, nursing, or trying to conceive allergic to latex, fluorescein, hydroxyethylcellulose, ascorbic acid, sodium citrate, citric acid using an intrauterine device (IUD) using depo-provera douching during the course of participation in the study had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months have a gynecological infection or other condition requiring treatment, such as candidiasis, chlamydia trachomatis, trichomoniasis, HIV, herpes simplex virus (HSV), neisseria gonorrhea, symptomatic bacterial vaginosis, or syphilis currently enrolled in any other research studies involving the application of vaginal formulations employed or supervised by the study investigators have any other condition that, in the opinion of the study physician, would contraindicate participation in the study
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Smoking age 18-50 years inclusive; 2. able to read and write English; 3. for women, being in follicular phase of menstrual cycle; 5) Tobacco dependent sample: smokes 10 or more cigarettes daily for the past year; Non-smokers, no tobacco consumption for more than one year and never having used tobacco daily any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with possible exception of nicotine dependence) as determined by SCID interview; 2. use of any psychoactive medication within past four weeks; 3. any significant unstable medical condition such as asthma or heart disease for which increased cardiovascular reactivity during stress challenge might constitute a significant risk; 4. IQ<70 based on past intelligence testing; 5. any metal in body that would pose a risk with MRI; and 6. claustrophobia that would interfere with MRI; 7. alcohol and drug use in the 72 hours prior to scanning, with the exception of tobacco; 8. pregnancy for women
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-50.0, Obesity Between ages 18-50 years old. 2. Able to read and write. 3. negative urine toxicology screens during intake appointments indicating no history of current or past dependence on alcohol or illicit drug use. 4. WOMEN: have a regular menstrual cycle. 5. BMI: 30 < BMI < 35 for obese subjects (upper limit of 35 selected given our experience with heavier individuals fitting comfortably in the fMRI scanner) and 18.5 < BMI <25 for normal weight subjects (Institute, 2006) any major neurological illness or injury and any current or prior clinically significant mental health (including PTSD) or substance use disorder (with exception of nicotine dependence) as determined by SCID interview; 2. Regular use of any psychoactive drugs including anxiolytics and antidepressants. 3. Any significant current medical condition such as neurological, cardiovascular, endocrine, renal, liver, thyroid pathology; subjects on medications for any medical condition will be excluded. 4. Any subjects with foreign ferromagnetic metal objects in their body or other MR contraindications will be excluded including subjects who work as welders. 5. Women on oral contraceptives, peri and post-menopausal women, and pregnant or lactating women (as alterations in stress response are associated with these states)
|
0
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-999.0, Consequences of Immunization Method healthy adults without latex allergy over 18 years of age latex allergy illness years or less
|
2
|
A 42-year-old healthy woman came to the clinic to have her flu shot in early October. She works in a rehab center and has no underlying disease. It's her first time getting the vaccine this year. She is married for 5 years and uses barrier methods of contraception. Her menstrual cycle is irregular. She does not smoke. She is not on any medications. She exercises regularly for 30 minutes a day at least 5 days a week. She has no history of allergies to any food or drugs. Her past surgical history is significant for tonsillectomy and she is otherwise healthy.
|
eligible ages (years): 18.0-80.0, Parkinson's Disease Patients with Parkinson's disease Age between 18-80 years Patients signed the consent form Patients with atypical parkinsonism
|
2
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.