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A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 1.0-18.0, Obstructive Sleep Apnea Syndrome Cleft Lip/Palate children with cleft lip/palate and signs and symptoms of OSAS, parents who can read and write English Parents who cannot read and write English, children with severe neurological compromise | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 5.0-10.0, Attention Disorder With Hyperactivity (ADHD) We will compare a group of children with ADHD, other psychiatric disorder, and a healthy group of children age 5 mental retardation - | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 3.0-12.0, Sleep Sleep Apnea Syndromes Sleep Disordered Breathing Assent of child (if over the age of 9 or younger but able to understand the nature of the study) At least one parent or guardian must sign an informed consent Child must be either a healthy volunteer or scheduled for an adenotonsillectomy for any reason Children scheduled for adenotonsillectomies must be referred to the program by a treating otolaryngologist who practices at the University of Michigan or St. Joseph Mercy Hospital in Ann Arbor, Michigan Mental or physical limitations that would prevent proper interpretation of neurobehavioral tests Medical history that could confound interpretation of EEG or behavioral data, including epilepsy, psychiatric diagnoses (other than disruptive behavior disorders), head trauma with loss of consciousness for more than 30 seconds, or chronic medication use (e.g., benzodiazepines, other hypnotics, or antihistamines) Current treatment by a physician or past surgical treatment for SDB A known medical condition that carries independent high risk of SDB (e.g., Pierre Robin syndrome, Down syndrome, or neuromuscular disorders) or excessive daytime sleepiness (e.g., narcolepsy) Inability to schedule polysomnography, a Multiple Sleep Latency Test, and neurobehavioral testing before the surgical date Determination by any of the patient's physicians that sleep testing is required before surgery can be scheduled (to avoid the possibility that study enrollment itself could affect ability to complete the study) Prior enrollment of a sibling in the study Expectation that the child will no longer have convenient access to University of Michigan facilities within 6 months or expectation of further surgery within that period Additional for healthy volunteers | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 20.0-80.0, Obstructive Sleep Apnea Age 20 to 80 yrs Apnea hypopnea index (AHI) > 10/hr on Polysomnograph (PSG) with symptoms of obstructive sleep apnea (OSA) as described previously Epworth Sleepiness Scale (ESS) >10 Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period Patients having problems staying awake during driving, shift work Recent myocardial infarction Unstable angina Underlying malignancy | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Seasonal Allergic Rhinitis Must be >=18 years of age and older, of either sex, and of any race Clinically symptomatic at Screening (Day -7 to -4)and at Baseline (Day 1) At Screening Visit, must have complaints of sleep disturbance while symptomatic with seasonal allergic rhinitis (SAR) and must have a score of 30 or greater for the Sleep Disturbance Sleep Scale (items 1,3,7 and 8) At the Baseline Visit, must have complaints of sleep disturbance and daytime somnolence while symptomatic with SAR and with a score of 30 or greater for the Sleep Problems Index II (SLP9) and 30 or greater for the Daytime Somnolence Sleep Scale (items 6, 9, and 11) Must have a 2-year or longer history of SAR occurring during the same season as the current study Must have skin tests positive for outdoor allergens common in subjects with SAR prevalent during the time of this study, such as, trees, grasses, weeds, ragweed, and molds. The skin tests should be performed at Screening if not done within 12 months prior to the Screening Visit Must be free of clinically significant disease that would interfere with study evaluations Women of childbearing potential need to use a medically accepted method of birth control prior to Screening and during the study, or provide documentation of surgical sterilization. Women who are not sexually active at enrollment must consent to the use of a medically accepted method of birth control if/when they become sexually active during study participation Female subjects of childbearing potential must have a negative urine pregnancy test at the time of enrollment at the Baseline Visit Women who are pregnant, intend to become pregnant during the study, or are nursing Evidence of nasal polyps, deviated septum, or other intranasal anatomical obstruction(s) that would interfere with nasal airflow Acute or chronic sinusitis being treated with antibiotics and/or topical or oral nasal decongestants Acute respiratory infection within 2 weeks of the Screening Visit Diagnosis of clinically relevant sleep problems unassociated with allergies Complaints (within 12 months of the Screening Visit to their health-care provider) of difficulty sleeping or daytime sleepiness while not experiencing SAR symptoms, and continue with these complaints Snoring associated with an enlarged uvula or other upper airway pathology Had episodes of snoring associated with gasping or choking Awakened suddenly, on more than 1 occasion during the month preceding the Screening Visit, with a gasping or choking feeling Requires the use of oral appliances at night for bruxism (teeth gnashing) or temporomandibular joint problems | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Sleep Apnea, Obstructive Experiences symptoms of OSA, including snoring and sleepiness Stable medical history with no change in medications that could affect sleepiness Suspected diagnosis of a sleep disorder other than OSA (i.e., periodic leg movements, narcolepsy, insomnia, central sleep apnea, sleep hypoventilation syndrome) Medically unstable health conditions (e.g., heart attack, congestive heart failure) Use of psychotropic medications that cause sedation in the 3 months prior to study entry Recent or confirmed history of recreational drug use or alcohol abuse Pregnant Inability to communicate verbally, write, or read Visual, hearing, or cognitive impairment | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 45.0-85.0, Parkinson's Disease 85 years of age and living in the community Male or female of non-child bearing potentials (non-child bearing is defined as at lease 6 months post-menopause or surgically sterile) Must have a diagnosis of Parkinson's disease Must have complaints of sleep disturbance Patients with diagnosis of or those meeting DSM-IV for major depression, schizophrenia or schizoaffective disorder, bipolar disorder, substance abuse disorder, other mental illness that is known to contribute to sleep disturbance, epilepsy, other medical conditions that are known to cause or contribute to sleep disturbances Patients currently using melatonin or ramelteon, hypnotics, benzodiazepines, antidepressants, blood-brain barrier permeable beta blockers, steroids, antipsychotics Patients with clinically significant blood or urine abnormalities Patients who have taken any investigational drug less than 1 month prior to the baseline visit Patients with multiple concomitant disorders with or without medications thought to produce sleep disturbances Patients with pre-existing sleep disturbances unrelated to Parkinson's disease Patients with severe hepatic impairment (Child-Pugh Class C) Patients with severe COPD (those with elevated pCO2 levels or those needing nocturnal oxygen therapy Patients with severe sleep apnea Patients who have sensitivity to ramelteon or any constituents of the Rozerem preparation | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 2.0-18.0, Insomnia Sleep Disorder Male or female between the ages of 2 years and 18 years Written consent must be obtained form the parent/legal guardian for all minors. Written assent must be obtained from all minors > 6 years of age Female subjects of child-bearing potential must not be pregnant and if females are fertile and sexually active, must have documented a negative urine HCG and assure use of effective contraception acceptable to the investigator (abstinence accepted) during the study period Subjects must meet the following for a diagnosis of insomnia as determined by the subject's private physician or study investigator and subject's history the complaint is significant difficulty (defined by frequency, severity, and/or chronicity) initiating or maintaining sleep;. The problem is viewed problematic by the child and/or caregiver the sleep disturbance causes clinically significant impairment in school performance, behavior, learning, or development for the child as reported by the child and/or caregiver the sleep disturbance does not occur exclusively in the context of an intrinsic dyssomnia such as narcolepsy, restless legs syndrome, or sleep-related breathing disorders; a circadian rhythm disorder; or a parasomnia the sleep disturbance is not attributable to either the direct physiologic effect of a drug of abuse or misuse of a prescribed medication Pregnancy and/or breastfeeding The presence of any untreated (where treatment is available), or unstable, progressive, or evolving clinically significant renal, endocrine, hepatic, respiratory, cardiovascular, neurologic, hematologic, immunologic, cerebrovascular disease or malignancy Elevations in screening blood tests of renal (SCr) and liver (ALT, AST and/or bilirubin) > 2 times the upper limit of normal for age Receiving any medications that may modulate Zolpidem metabolism, primarily drugs that will enhance or reduce the activity of CYP450 3A, 2C9, or 2D6 activity. Note: If patient is receiving a medication that might be considered an inducer or an inhibitor, please discuss with the PI prior to excluding them Receiving any medications with sleep-impairing properties at a dose/dose interval that would be judged by the study investigator as to interfere with the assessment of Zolpidem sleep response Currently using any systemic contraceptive steroids including: oral contraceptives, transdermal patch, vaginal insert, levonorgestrel implant and medroxyprogesterone acetate contraceptive injection | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 30.0-80.0, Sleep Apnea, Obstructive Continuous Positive Airway Pressure OSA confirmed by polysomnography (PSG) CPAP is the prescribed form of treatment for OSA Judged by sleep physician to respond to CPAP Apnea/hypoxia index (AHI) less than 15 and no daytime functional symptoms or associated cardiovascular disease Diagnosis of another sleep disorder that causes arousals from sleep Past treatment for OSA Current substance abuse problem Diagnosis of a serious medical condition that would interfere with involvement in the study History of a major psychiatric disorder, other than depression Change in antidepressant medication in the 3 months before study entry | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 4.0-9.0, Sleep Problems Diagnosis of ASD Age greater than or equal to 4 or less than or equal to 9 years Current sleep problems, as defined as a composite score of greater than 41 on the CSHQ Failed sleep hygiene, as described below Parents must be fluent in English in order to complete CSHQ and ABC, validated in English only Parents have given informed consent Current use of psychoactive medications (e.g. fluoxetine, methylphenidate, risperidone, lithium, etc.) Current or use within the last month of beta-blockers or melatonin Current use of sleep aids Presence of untreated medical problems that could otherwise explain sleep problems (e.g. obstructive sleep apnea, gastroesophageal reflux disease (GERD)) 5) Blindness | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-65.0, Schizophrenia Key The patient has a diagnosis of schizophrenia according to the DSM-IV-TR and the patient has been clinically stable in a nonacute phase of their illness Documentation that the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of that antipsychotic medication for at least 4 weeks prior to the screening visit The patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. Acceptable methods of contraception barrier method with spermicide, intrauterine device (IUD), steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method, or documented abstinence The patient has a PANSS negative symptom score of 15 or more at the screening and baseline visits Key The patient has a severity rating of moderate or worse on any item of the PANSS positive symptom subscale The patient has any Axis I disorder according to DSM-IV-TR including schizoaffective disorder, apart from schizophrenia and nicotine dependence, or any Axis II disorder that would interfere with the conduct of the study The patient has moderate to severe depressive symptoms, as indicated by the CDSS The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has tardive dyskinesia, akathisia, moderate or worse level of extrapyramidal symptoms, or any other clinically significant movement disorder The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or has a history of multiple clinically relevant allergies The patient is a pregnant or lactating woman The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 9.0-14.0, Sleep Difficulties in Pediatric Anxiety Disorder Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP) Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)" The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains difficulties going to sleep difficulties waking during the night difficulties getting up on time for school because of tiredness/sleepiness daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep erratic sleep-wake schedules IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI) Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants Acutely suicidal or at risk for harm to self or others Any motor impairments or eye-hand coordination problems Sleep disorder or parasomnia Taking any medication that might interfere with sleep Has a medical problem that might interfere with sleep | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 21.0-999.0, Obstructive Sleep Apnea Consenting adults over the age of 21 Diagnosed obstructive sleep apnea Unstable cardiovascular disease Uncontrolled hypertension (BP > 190/110) Severe intrinsic lung diseases (supplemental O2 > 2 L/min during the day) History of chronic renal insufficiency History of hepatic insufficiency Pregnancy Bleeding disorders or Coumadin use Sleep Disorders other than OSA Tracheostomy Allergy to lidocaine | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 21.0-999.0, Obstructive Sleep Apnea years or older Patient of the Weill Cornell Pulmonary Associates and Cornell Center for Sleep Medicine practices Clinically indicated for an overnight sleep study within six months prior to or after the outpatient office visit Pregnancy | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-65.0, Resistant Hypertension Obstructive Sleep Apnea Age 18 known hypertension on ≧ 3 anti-hypertensive drugs Apnea-hypopnea index ≧15 able to give informed written consent moderate renal impairment (glomerular filtration rate <30 mL/min/m2 ) endocrine/renal/cardiac causes of secondary HT congestive heart failure and clinically fluid overloaded On drugs that elevates BP e.g. NSAID, steroid Non-compliance to anti-hypertensive medications Unstable medical conditions such as unstable angina, recent myocardial infarction/stroke within 3 months Active inflammatory/infective conditions e.g. rheumatoid arthritis Excessive sleepiness that can be risky e.g. occupational driver, machine operator Modification/changes of anti-hypertensive regimen within 8 weeks | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 4.0-10.0, Autistic Disorder Insomnia Children with autism ages 4-10 years Diagnosis of autism based on Autism Diagnostic Observation Schedule (ADOS) Time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months Children may take seasonal allergy medications Children may take the following medications for the same dose at least 3 months: Citalopram (Celexa), Escitalopram (Lexapro), Amphetamine-dextroamphetamine (Adderall), Atomoxetine (Strattera), Methylphenidate(Ritalin), Dextroamphetamine(Dexedrine), Risperidone (Risperdal Children taking medications other than those in the criteria Children with primary sleep disorder other than insomnia (such as sleep-disordered breathing) Children with non-febrile unprovoked epileptic seizure within the last two years Children with liver disease or high fat diets, as melatonin metabolism may be affected in these children Children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms Children with known genetic syndromes co-morbid with autism including fragile X, Down syndrome, neurofibromatosis, or tuberous sclerosis Children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of ACTH, cortisol, LH, FSH, prolactin, testosterone and estradiol Tanner staging beyond level 1 at any time point in the study Children whose assessment score does not place them on the autism spectrum | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 8.0-18.0, Brain Tumors Age ≥8 to ≤ 18 years of age Brain tumor survivor ≥5 years post diagnosis ≥2 years post active cancer-directed therapy or observation only Parents speak and read English fluently Potential participant reads English fluently Potential participant/guardian willing to sign consent Survivor of any cancer other than a brain tumor | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Sleep Apnea Adults more than 18 years old Subjects Unwilling to Complete the Questionnaire | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 5.0-7.25, Sleep Healthy child age 5-6 years old School enrollment for a minimum of 5 hours/day Positive Children's Sleep Habits Questionnaire (score ≥ 41) Permanent housing for the previous 12 months Permission for research staff to complete 5-9 home over 1 year Have telephone access or a contact with telephone access Fluent in either English or Spanish Serious co-morbid condition that may impact sleep including genetic syndromes neuromuscular disorders seizure disorder mental retardation autism severe learning disabilities psychiatric disorders attention-deficit/hyperactivity disorder | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Sleep Apnea, Obstructive diagnosis of obstructive sleep apnea syndrome other causes of dysphagia pharyngeal surgery prior treatment for obstructive sleep apnea | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-80.0, Obstructive Sleep Apnoea Hypopnoea Syndrome Biomarkers of Fibrin Clot Structure Biomarkers of Vascular Endothelial Injury 80 year old with h/o daytime sleepiness, snoring and apnoeas Refusal to give written informed consent Personal or family history of pro thrombotic or bleeding disorders, severe liver disease (clotting problems) and those prescribed warfarin or heparin Those with borderline sleep studies (4% Diprate or AHI 10-14 per hour) Aged less than 18 years or greater than 80 years | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 5.0-12.0, Sleep Apnea, Obstructive Sleep Apnea Syndromes Child Behavior Disorders Attention Deficit Disorder With Hyperactivity Disorders of Excessive Somnolence Children ages 5-12 years old Scheduled for an adenotonsillectomy for treatment of sleep apnea Child must provide assent, and Parent or legal guardian must be able to speak and read English, and agree to the study No siblings of children already enrolled in the study Children who expect to have another surgery (in addition to AT) during the period of participation in this study Neurological, psychiatric, or medical conditions, or social factors that may affect test results, prevent children from returning for required study visits, or interfere with the study treatment, or Certain medications that affect sleepiness or alertness, for example Stimulants (such as Ritalin, Adderall, or Concerta) Sleep aides (such as Melatonin, Ambien, or Ativan), or Sedating medicines (such as Benadryl, Klonopin, Xanax, or Valerian) | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 40.0-52.0, Menopausal and Other Perimenopausal Disorders Age 40-52 History of regular menstrual cycles every 20-35 days in mid-reproductive life (20-35 years of age) At least 1 period within the past 3 months BMI less than 35 kg/m2 Presence of at least one of the following perimenopausal symptoms Hot flashes (vasomotor symptoms) Cyclical headache, bloating or adverse mood Self-reported poor quality of sleep Age < 40 years Hysterectomy or bilateral oophorectomy Cigarette smoking Signs or symptoms of restless leg syndrome or sleep apnea Any chronic renal or hepatic disease that might interfere with excretion of gonadotropins or sex steroids Moderate/vigorous aerobic exercise > 4 hours per week Inability to read/write English Pregnant Women Prisoners Decisionally challenged subjects | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-75.0, Obstructive Sleep Apnoea males and females, age >18years and <75years, body-mass index (BMI) >18 and <40kg/m2, non-smokers, sleep apnoea with an ODI ≥15/h or sleep apnoea with an ODI ≥5/h plus an Epworth sleepiness score >10 morbid obesity (BMI>40kg/m2) or cachexia (BMI<18kg/m2), obesity-hypoventilation syndrome (total sleep time with SpO2<90% of more than 10% of the night), active smokers or smoking history of >20pack years, acute or critical illness, acute psychosis or chronic mental disorder affecting capacity, previous home-mechanical non-invasive ventilation and metal implants in the upper part of the body (this excludes dental implants) | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-90.0, Sleep Apnoea Syndrome patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory male and female patients aged at least 18 years persons who understand and follow the instructions of the study staff singed informed consent persons being housed in an institution by court or governmental order pregnancy or breastfeeding patients who are not able to consent acute or chronic inflammations of the external and middle auditory canal abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal persons in a dependence or in an employment contract to the investigator participation in another study at the same time | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-75.0, Obstructive Sleep Apnea Syndrome Patients with low or medium suspicion of Sleep Apnea Patients with notorious comorbidity Age between 18 and 75 years Capability to fill in written questionnaires Patients with high suspicion of sleep apnea Serious heart disease, resistant systemic hypertension, Suspicion of non-apneic sleep disorders, such as narcolepsy, REM behavior disorders and restless leg syndrome Patients with diagnosis of SAHS Lack of informed consent | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-65.0, Obstructive Sleep Apnoea (OSA) BMI > 35 attending bariatric surgery retrognathia micrognathia acromegaly downs syndrome | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 20.0-85.0, Obstructive Sleep Apnea Central Sleep Apnea Mixed Sleep Apnea Cheyne-Stokes Respiration Able to understand and sign the informed consent Able to comply with visits and follow ups included in this protocol Ages 20-85 years An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection Skin rash on the nose or on the maxillary area A history of skin allergy to medical tape, and hypoallergenic tapes A history of skin cancer on the nose or on the maxillary area A history of the base of skull fractures, facial fractures | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 6.0-18.0, Snoring Ability to understand how to perform reaction time test and complete without assistance Children who are unable to understand or perform test or parents refusal | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Obstructive Sleep Apnea End Stage Renal Disease end stage renal disease on renal replacement therapy age ≥ 18 years unstable congestive heart failure active psychiatric disease | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 2.5-5.917, Sleep Initiation and Maintenance Disorders Age 30-71 months Child behavioral sleep problem, as demonstrated by a score on the Children's Sleep Habits Questionnaire (CSHQ) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night English speaking parent or guardian Sleep disordered breathing, as demonstrated by a score on the CSHQ of at least 5 Currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids Serious medical conditions likely to affect sleep, including diabetes or cancer Major cognitive or developmental disorder, including autism spectrum disorder | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 16.0-999.0, Acromegaly Adults aged 16 and above Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea Have capacity to given informed consent Patients under 16 years of age Not referred to the Sleep Apnoea Clinic Unable to give informed consent | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-35.0, PCOS Sleep Apnea Females 18 years old Receiving care at University of South Florida Reproductive Endocrinology Offices Polycystic ovarian syndrome defined by the modified Rotterdam Able to speak and understand as well as give informed consent in English Late onset congenital adrenal hyperplasia Cushings disease Androgen-secreting tumors Previous diagnosis of obstructive sleep apnea Current use of over the counter or prescribed sleep medications Examples of medications that a patient from this study but are not limited to Unisom, Ambien or Lunesta Patients who are taking non-prescribed herbal medications for sleep will not be excluded from the study. Examples of these but are not limited to melatonin, chamomile, or valerian Untreated thyroid disease Prolactin excess Patients with the following medical conditions will be excluded from the study as portable sleep apnea monitors are not indicated in patients with severe pulmonary disease, neuromuscular disease, or congestive heart failure | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 3.0-12.0, Obstructive Sleep Apnea Syndrome Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram Children who are suffered from any chronic medical or psychiatric condition Children with acute respiratory infection Children with severe craniofacial deformities Children with cardiopulmonary diseases Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-18.0, Sleep Apnea Sudden Cardiac Death Heart Failure Ischemic Cardiomyopathy Patients with ICM indicated for ICD/CRT-D implant based on current ESC Guidelines for primary prevention of sudden cardiac death Previously diagnosed sleep apnea CPAP, BiPAP or ASV treatment Patients with previously implanted ICD/CRT-D device indicated for device replacement Uncontrolled hypertension Severe valvular heart disease/dysfunction with exception of ischemic and functional mitral regurgitation Acute coronary syndrome or acute cardiac decompensation in 4 weeks before ICD/CRT-D implant Expected indication of heart transplant in period of 12 months or less after ICD/CRT-D implant Expected cardiac surgery or percutaneous coronary intervention in period of 12 months or less after ICD/CRT-D implant Severe pulmonary diseases Rejection of participation in the study Pregnancy | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Sleep Apnea Syndrome Men and Women over 18 years old Diagnosed as OSA and requiring CPAP treatment Written informed consent form signed Patients with impaired lung function (overlap syndrome, obesity hypoventilation syndrome, and restrictive disorders) Severe heart failure Severe chronic pathology associated Psychiatric disorder Periodic leg movements Pregnancy Other dyssomnias or parasomnias Patients already treated with CPAP | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-90.0, Obstructive Sleep Apnoea Obesity Hypoxia men with or without obstructive sleep apnoea weight loss interventions steroid use active smoking | 0 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 3.0-10.0, Sleep-Disordered Breathing Diagnosis of mild sleep-disordered breathing (MSDB) defined by an obstructive apnea index (OAI) <1/hr and an apnea-hypopnea index (AHI) <2/hr confirmed by nocturnal polysomnography Parental report of habitual snoring defined as occurring on average >3 nights per week Tonsillar hypertrophy ≥2+ Deemed to be a surgical candidate for adenotonsillectomy by otolaryngologist evaluation Previous tonsillectomy Recurrent tonsillitis that merits prompt adenotonsillectomy (AT) per the American Academy of Otolaryngology-Head and Neck Surgery Clinical Practice Guidelines (i.e., ≥7 episodes/yr in the past year; ≥5 episodes/year over the past 2 years or ≥3 episodes/yr over the past 3 years.) Severe obesity (body mass index (BMI) z-score ≥3) Severe chronic health conditions that might hamper participation or confound key variables under study Current use of psychotropic medication (other than medications for attention deficit hyperactivity disorder(ADHD)), hypnotics, antihypertensives or growth hormone History of severe developmental disability or Adaptive Behavior Assessment System (ABAS) score <60 Parent/guardian unable to accompany the children on the night of polysomnography (PSG) Family planning to move out of the area within the year Family does not speak English | 1 |
A 10 yo boy with nighttime snoring, pauses in breathing, and restlessness with nighttime awakenings. No history of headache or night terrors. The boy's teacher recently contacted his parents because she was concerned about his declining grades, lack of attention, and excessive sleepiness during class. | eligible ages (years): 18.0-999.0, Sleep Apnea/Hypopnea Syndrome Age 18 years or older No previous diagnosis of sleep apnea Fulfilling at least one of the following Pacemaker indication ICD or CRTD therapy indication Heart failure and preserved LVEF (40-50%) Heart failure and reduced LVEF (<40%) Signed informed consent Age younger than 18 years Renal hemodialysis Cardiac transplant indication Women who are pregnant Advanced cancer Enrollment in another investigational study Able and willing to comply with all testing and requirements Patient not suitable for due to psychiatric conditions or short life expectancy | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Cysticercosis Cysts Seizures years of age or older. If children are evaluated they can be seen under the general protocol and they may be entered into the present protocol under an exception Likely diagnosis of inactive cysticercosis and present or past seizure activity. Requires "a" and "b" plus any one of the remaining History of seizures or present seizure activity Previously treated or has inactive disease and declines treatment Single calcified lesions and positive serology Multiple calcified lesions Multiple small enhancing nodular lesions History of cystic lesions responding to specific chemotherapy If female, not pregnant and using effective birth control methods Less than 18 years of age Pregnant or unwilling to use effective birth control measures Refuse blood tests Unwilling or unable to undergo testing according to the schedule Unable to undergo MRI or CT examinations Patients who require anesthesia to undergo imaging studies | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Lung Diseases, Obstructive Chronic Obstructive Pulmonary Disease | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 50.0-80.0, Osteoporosis 80 years of age, inclusive years since last menses Dx femoral neck osteoporosis No vertebral fractures Poor candidate for study drugs Hx of diseases affecting bone metabolism Hx of breast/estrogen-dependent cancer Current use of osteoporosis drug therapy Hx/high risk of VTE | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Small Cell Lung Cancer Written informed consent (patient's written understanding of and agreement to participate in this study) Patients with confirmed extensive small cell lung cancer (SCLC) No prior chemotherapy within 5 years of the diagnosis of SCLC Presence of either measurable or non-measurable SCLC by X-ray or physical examination At least 3 weeks since last major surgery (a lesser period is acceptable if decided to be in the best interest of the patient) At least 24 hours since prior radiotherapy. Patients who have received radiotherapy must have recovered from any reversible side effects, such as nausea and vomiting Laboratory Patients must have adequate bone marrow reserve and adequate kidney and liver function Symptoms of spreading of the disease to the brain that requires treatment with drugs called steroids Any active infection Severe medical problems other than the diagnosis of SCLC, that would limit the ability of the patient to follow study guidelines or that would expose the patient to extreme risk Ongoing or planned chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of SCLC Use of an investigational drug within 30 days before the first dose of study medication Women who are pregnant or lactating Patients of child-bearing potential who refuse to practice an adequate form of birth control Patients with clinical evidence of any stomach or intestinal (GI) condition Patients requiring treatment with the drug cyclosporin A | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Sepsis Adult patients with severe sepsis Presence of a suspected or proven infection One or more sepsis-associated organ failure Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country Platelet count <30,000/mm3 Are receiving therapeutic heparin | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Severe Acute Respiratory Syndrome Healthy adults, children and cord blood | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Colon Mucinous Adenocarcinoma Colon Signet Ring Cell Adenocarcinoma Lynch Syndrome Stage IIA Colon Cancer Stage IIB Colon Cancer Stage IIC Colon Cancer STEP 1 The distal extent of the tumor must be >= 12 cm from the anal verge on endoscopy; if this distance was not confirmed on endoscopy pre-operatively, then the distal extent of the tumor must be >= 12 cm from the anal verge as determined by surgical examination; colonoscopy should be performed postoperatively for those unable to have a preoperative colonoscopy to guarantee there are no synchronous lesions; (if tumor is located beyond sigmoid colon and centimeter distance unavailable, anatomic region of colon, e.g. right colon, transverse colon, hepatic flexure descending colon, cecum etc.) Patients must have paraffin-embedded tumor specimen available for evaluation of microsatellite instability and loss of heterozygosity at 18q, to determine high risk versus low risk High-risk patients will be randomized to treatment Arms A or B Low-risk patients will be registered to Arm C for observation NOTE: Every effort should be made to submit blocks (tumor and normal mucosa) to the Principal Coordinates Analysis (PCO) immediately; blocks be accepted after day 50 (post surgery) in order to allow for molecular assessment Specific laboratory requirements for Step 2 must be obtained within 2 weeks prior to Step 2 randomization Patients must not have synchronous tumors Patients must not have appendiceal tumors Patients must not have a history of inflammatory bowel disease (IBD) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 8.0-17.0, Asthma Allergy Children and adolescents between 8 and 17 years of age at the start of the trial (born after 01 March '88, but before 01 September '97) Bronchial asthma, diagnosed by a physician, and confirmed by a physician at a paediatric department of a Norwegian Hospital Allergy against dogs, confirmed by skin prick test. Average infiltrate at least 4 millimetres against dog, diagnosed by a new skin prick test at entry. For details about skin prick test, see attachment no. 6 Having had nose or breathing symptoms by contact with dogs, when no drugs against asthma or allergy have been taken Able to co-operate at cold air hyperventilation test and spirometry (see attachment no. 2) Given written consent (by parents of children below 12; by parents and child when above 12, but below 16; by patient when above 16) Positive house dust mite skin prick test, with a more than 3 mm infiltrate Having taken oral beta-2-agonists or theophylline preparations for the last 2 weeks before trial start, or oral steroids for the last 3 months before start of the trial Active smoking Dogs or cats in the home Staying away from the home continuously for more than 14 days in the trial period or during the last month before trial start Being an in-patient in a special department or institution for asthma and allergy in the trial period or the last 3 months before the trial Having another chronic disease that can influence the results of ECP or cold air hyperreactivity tests Other types of mechanical ventilation or air filtration systems in the homes, except for those for kitchen stoves | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-90.0, Abscess Cysts Female or male, aged between 18 and 90 years Written informed consent Abscess formation or abdominal cyst scheduled to drainage Plasma creatinine <1.5 mg/dL Pregnancy or lactation Hemodialysis or hemofiltration Allergy or hypersensitivity against study drugs Massive edemata or hypernatremia Reduced liver function (Child-Pugh A, B, C) Relevant prolongation of QT-interval CNS-diseases which predispose for cramps | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-65.0, West Nile Fever A participant must meet all of the following 18 to 65 years old Available for clinical follow-up through Week 32 and contact (correspondence, telephone or e-mail) or clinical visit through Week 52 of the study Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly Able and willing to complete the informed consent process Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results Willing to donate blood for sample storage to be used for future research and genetic testing, including HLA analysis In good general health without clinically significant medical history and has satisfactorily completed screening Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment A volunteer will be excluded if one or more of the following conditions apply Women Breast-feeding or planning to become pregnant during the 32 weeks of study participation Volunteer has received any of the following substances Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded) Blood products within 120 days prior to HIV screening Immunoglobulin within 60 days prior to HIV screening Investigational research agents within 30 days prior to initial study vaccine administration Live attenuated vaccines within 30 days prior to initial study vaccine administration Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-50.0, Ebola Hemorrhagic Fever Ebola Virus Disease Ebola Virus Vaccines Envelope Glycoprotein, Ebola Virus Filovirus A subject must meet all of the following 18 to 50 years old Available for clinical follow-up through Week 48 Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly Able and willing to complete the informed consent process Willing to donate blood for sample storage to be used for future research In good general health without clinically significant medical history Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment Laboratory within 28 days prior to enrollment A subject will be excluded if one or more of the following conditions apply Women Breast-feeding or planning to become pregnant during the first 24 weeks after enrollment Subject has received any of the following substances Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. [Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.] Blood products within 120 days prior to HIV screening Immunoglobulin within 60 days prior to HIV screening Live attenuated vaccines within 30 days prior to initial study vaccine administration Investigational research agents within 30 days prior to initial study vaccine administration | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-26.0, Behavioral Disorders Being less than 26 years old Being pregnant for less than 27 weeks Being primiparous Living in the study area Being socially vulnerable: less than 12 years of education AND/OR socially isolated AND/OR eligible for a public health insurance for people with low resources Refusal to participate Not able to speak French Having a medical follow-up which necessitates regular contact with health professional Not having health insurance Persons for whom follow up at 27 months is impossible (evaluation at baseline) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Influenza For pediatric population: Age of patient: 30 days years; for adult population: any age Illness onset within past 5 days Symptoms of fever (>=38°) plus one or more of the following: cough, runny nose, congestion, or sneezing (twice or more within one day). These symptoms must be present at the time of presentation to the emergency department (ED) or admission to the hospital Patient or parent/guardian is able to give informed consent Pediatric patient or non-verbal adult is not accompanied by a caregiver Participant/caregiver cannot be reached by phone in 7-10 days Patient has a condition that can compromise respiratory function or the handling of respiratory secretions (e.g., severe cognitive dysfunction, spinal cord injuries, or other neuromuscular disorders) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Hypertension Obesity patients with essential hypertension aged >/= 18 years with one of the following risk factors: history of coronary artery disease or stroke/TIA or peripheral artery disease or diabetes mellitus according to SPC | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Scrub Typhus were Adults aged 18 years or older A fever of higher than 37.5°C The concurrent presence of eschar or a maculopapular skin rash; and the clear presence of more than two symptoms such as headache, malaise, myalgia, coughing, nausea and abdominal discomfort Patients were hospitalized at Chosun University Hospital in Kwangju, Korea or one of its two community-based affiliated hospitals which are all located in southwestern Korea between 2006 and 2009 The were An inability to take oral medications Pregnancy Hypersensitivity to the trial drugs Previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission Severe scrub typhus (shock requiring vasopressor therapy for more than one hour A stuporous or comatose level of consciousness Respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis) (4, 10) For the differential diagnosis of scrub typhus from other diseases with similar symptoms (e.g., murine typhus, leptospirosis, hemorrhagic fever with renal syndrome and systemic lupus erythematosus), patients underwent diagnostic tests. We thus excluded patients with concurrent infections who had the risk of causing different outcomes | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Child Abuse resident of Durham, NC a child between the ages of 0-7 was the focus of the Department of Social Services report child's caregiver was the focus of the report Child Protective Services report occurred on or after June 1, 2004 family is English speaking Sexual abuse was not "confirmed" or "highly suspicious" during an evaluation Child Protective Services report of sexual abuse that was "confirmed" or "highly suspicious" | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 15.0-90.0, Leptospirosis adult patients (> 14 years) with suspected severe leptospirosis patients who presented with acute fever (oral temperature more than 38.00 C for <15 days) in the absence of an obvious focus of infection In the opinion of the attending physician might have pulmonary hemorrhage (i.e. history of hemoptysis, and/ or bilateral nodular or air space infiltration) pregnant or breastfeeding those with history of bleeding disorder those who had underlying diseases such as chronic liver disease, diabetes mellitus those who received diuretic or glucocorticoid | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-45.0, Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (≥ 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Leishmaniasis DoD healthcare beneficiary of any age and gender Clinicoepidemiologic or parasitologic diagnosis (microscopy, PCR or culture) of Leishmania infection Able to provide informed consent or assent (children) All participants (both male and female) must agree to take precautions not to become pregnant or father a child for at least 2 months after receiving SSG Pregnancy. Females of childbearing potential must have negative urine human chorionic gonadotropin hormone (HCG) within 96 hours start of infusion period History of hypersensitivity to pentavalent antimonials Any of the following on screening examination QTc interval greater or equal to 0.5 sec Severe cardiac disease (disabling valvular heart disease, myopathy, or arrhythmias) History of recurrent pancreatitis Liver failure or active hepatitis with transaminases > 3x upper limit of normal Renal failure or creatinine > 2.5 mg/dL Thrombocytopenia (platelets <100,000/mm3) White blood cell count < 2000 / mm3 | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-70.0, Acute Viral Hepatitis Diabetes Mellitus All patients between the ages of 18 to 70 years Recent intake of drugs known to cause acute hepatitis History of alcohol ingestion >40mg/day Suspected ischemic hepatitis Illness causing acute hepatitis such as Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia HIV Associated co morbidities, which can affect survival such as cardiovascular disease and diabetic nephropathy Recent intake of drugs known to cause acute hepatitis History of alcohol ingestion >40mg/day Suspected ischemic hepatitis Malaria hepatits, enteric hepatitis, Leptospirosis, septecemia | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 21.0-999.0, Headache All patients who describe a painful sensation in the head as one of the primary reasons for their visit to the ED patients who need immediate oxygen after triage: Recent fire or carbon monoxide exposure_______ O2 saturation 94% or less on room air on triage vitals ______ patient arrives on supplemental oxygen_______ patient reports shortness of breath_______ patients in whom 100% oxygen is contraindicated, potentially undesirable, or controversial: history of COPD_______ possible cardiac ischemia (mouth / jaw / neck / shoulder / chest / abdomen pain or pressure)_______ possible stroke (new focal weakness or numbness, speech, hearing or vision deficit, bowel or bladder incontinence or retention)_____ patients unable to tolerate the gas treatment: patient not able to tolerate a face mask_______ patient requests immediate treatment with another preferred therapeutic agent_______ treating physician or nurse request to discontinue the study at any point_______ patients who have diminished decision-making capacity history of mental retardation or pervasive developmental disorder_______ patient not awake and alert_______ patient not oriented to self, month and year, and current location_______ patient unwilling or unable to fully participate in the research associate interview and consent process_______ patients who are at risk for intracranial hemorrhage history of intracranial aneurythm, hemorrhage, surgery, or tumor_______ current headache began after trauma_______ current headache began after using elicit drugs_______ patients who are at high risk for intracranial infection fever > 100.4 F on triage vitals_______ complaining of recent onset neck stiffness_______ patients who are at high risk for extracranial head pathology ear pain or drainage_______ tooth or gum pain_______ headache localized to a skin lesion on the head______ patient is potentially critically ill active bleeding from any source_______ heart rate <60 or >130 on triage vitals_______ systolic blood pressure <90 or >180 on triage vitals_______ respiratory rate < 10 or >30 on triage vitals_______ patient is younger than 21_______ | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Recurrent Large Cell Lung Carcinoma Recurrent Lung Adenocarcinoma Recurrent Squamous Cell Lung Carcinoma Stage IV Large Cell Lung Carcinoma Stage IV Lung Adenocarcinoma Stage IV Squamous Cell Lung Carcinoma Patients must have histologically or cytologically proven primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous or unspecified); disease must be stage IV; disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation; patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease will not be considered to have stage IV disease and are not eligible Patients must have a computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain to evaluate for central nervous system (CNS) disease within 42 days prior to registration; patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day Patients may have measurable or non-measurable disease documented by CT or MRI; the CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality; measurable disease must be assessed within 28 days prior to registration; pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease; non-measurable disease must be assessed within 42 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients must have tumor tissue available for submission that is sufficient for EGFR FISH testing and must agree to submission of these specimens; patients must also agree to submission of specimens for other translational medicine studies; patient must be offered participation in banking for future research Patients must not have received prior chemotherapy for any stage non-small cell lung cancer; patients must not have received prior platinum-based chemotherapy for any purpose; patient must not have received any cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway; patients must not have received for any purpose prior bevacizumab or other vascular endothelial growth factor (VEGF)-related agents; patients must not have received for any purpose prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA) Prior radiation is permitted; however, patients must have recovered from all associated toxicities at time of registration; in order to qualify as measurable, measurable disease must be outside the previous radiation field or must have progressed Time from surgical or biopsy procedures is dependent on whether it is planned for the patient to receive bevacizumab For patients who are bevacizumab-appropriate AND bevacizumab is planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or video-assisted thoracoscopic surgery [VATS] resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 14 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), thoracentesis or central venous access device implanted within 7 days prior to registration; for other surgical procedures not listed here, please contact the study coordinators For patients who are bevacizumab-inappropriate or bevacizumab is not planned: at least 28 days must have elapsed since major surgery (i.e. thoracotomy or VATS resection of lung cancer, open pleural biopsy or another major surgical procedure such as abdominal surgery) or significant traumatic injury; patients must have recovered from all associated toxicities at the time of registration; there must be no anticipation of need for major surgical procedures during protocol treatment; patients must not have had a core biopsy, mediastinoscopy, pleurodesis, VATS pleural biopsy or VATS pericardial window within 7 days prior to registration; patients must not have had a percutaneous fine needle aspiration (FNA), or thoracentesis within 1 day prior to registration; patients may have had a central venous access device placed at any time prior to registration; for other surgical procedures not listed here, please contact the study coordinators Absolute neutrophil count (ANC) >= 1,500/mcl | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 17.0-65.0, Crimean-Congo Hemorrhagic Fever Lassa Fever An individual will be enrolled in this study if the patient Meets the case definition for a probable or a suspected case of CCHF or LF (see below) Has read and signed the Informed Consent Is at least 18 years of age (17, if active military) and not greater than 65 years of age Has a blood sample drawn and a type and cross-match ordered for transfusion Agrees to collection of required specimens Agrees to report any Adverse Events, Serious and Unexpected Adverse Events for the duration of the study Agrees to a follow-up visit and to donate blood and urine specimens at day 14 (±2 days) and once between days 28 and 60 after the first dose of IV Ribavirin and to all follow-up visits for anemia or other medical conditions as required by the attending physician Woman of childbearing age must have a pregnancy test performed. If negative, she must agree not to become pregnant during treatment and for 7 months after receiving Ribavirin. She also must agree to not breast feed during treatment and for 7 months after receiving Ribavirin. Two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period. She will be counseled concerning the risks of IV Ribavirin versus no treatment if the pregnancy test is positive Man agrees not to have intercourse with pregnant woman during treatment and for 7 months after receiving Ribavirin, and take precautions to avoid producing pregnancies during treatment and for 7 months after receiving Ribavirin. At least two reliable forms of effective contraception must be used including one barrier method during treatment and during the 7 month post-treatment period to avoid a pregnancy Has known intolerance to Ribavirin Is irreversibly ill on presentation, as defined by presence of profound shock (shock which does not respond to supportive therapy within 3 hours after admission) Has hemoglobin less than 10 g/dL that cannot be corrected to 10 g/dL before initiation of IV Ribavirin Has history of hemoglobinopathies (i.e., sickle-cell anemia or thalassemia major) Has history of autoimmune hepatitis Has a calculated serum creatinine clearance of < 30 mL/min History of such as second or third degree heart block or sick sinus syndrome and without a pacemaker and no capability of a pacemaker placement or Wolfe-Parkinson-White Syndrome A sinus bradycardia of less than 40 beats per minute Is currently being treated with Didanosine (ddI). ddI must be discontinued before starting IV Ribavirin Relative | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-80.0, Septic Shock Sepsis all patients aged between 18 and 80 years old with the diagnostic of septic shock or severe sepsis pregnants previous diagnosis of any cancer diagnosis of leptospirosis diagnosis of aids | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Flavivirus Infection Alphavirus Infections Malaria Parasitic Disease Leptospirosis Hypertension Metabolic Syndromes For community participants: Health volunteers who are willing to join this study (including the stool and blood testing) after explanation and sign the informed consents For hospital cases: The patients ,who were suspicious of malaria, leptospirosis, Alpha-viral(Chikungunya virus, Ross river virus), and flavivirus infections (dengue fever, Japanese encephalitis..ect) by the attending physicians, will be informed about this study by drawing blood samples if they agree to participate The participants whose stool or blood samples were in-adequate or missing will be excluded from this study The participants whose documented personal information is fake or cannot be identifiable will also be excluded from this study | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Kidney-transplant Recipients With Chronic Hepatitis E Virus Infection Age > 18 years Transplanted by a functional kidney affected by a hepatitis E chronic Benefiting from a follow-up in the Center of Nephrology and renal Transplantation or in the service of Hépato-gastro-entérologie of the CHU The Conception in Marseille Having signed a consent informed about participation in the study Affected by another sharp or chronic viral infection | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-85.0, Japanese Encephalitis Living in the specific 2 villages in Hualien county Aged 18-85 Difficulty to have blood test due to coagulopathy or small blood vessels | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, QIAGEN ResPlex II Advanced Panel Influenza A Influenza B Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza A, Influenza B, Subjects that sign the Informed Consent form required for prospectively enrolling patients into the study Subjects that present at a hospital, clinic, or physician's office with the signs and symptoms of a respiratory tract infection Subjects with an acute respiratory infection where said acute respiratory infection is suspected of being caused by an Influenza virus Subjects where the duration of the symptoms of such an acute respiratory infection is greater than or equal to 5 days (i.e., ≥5) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 40.0-80.0, Pulmonary Disease, Chronic Obstructive Type of subject: outpatient Informed consent: Subjects must give their signed and dated written informed consent to participate Gender: Male or female. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to or women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception Age: >=40 and <=80 years of age at Screening (Visit 1) Tobacco use: Subjects with a current or prior history of >=10 pack-years of cigarette smoking at screening (Visit 1). Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 Airflow Obstruction Subjects with a measured post-albuterol/salbutamol forced expiratory volume in 1 second (FEV1)/(forced vital capacity)FVC ratio of <=0.70 at Screening (Visit 1) Subjects with a measured post-albuterol/salbutamol FEV1 >=50 and <=70% of predicted normal values calculated using III reference equations [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1) Post-bronchodilator spirometry will be performed approximately 15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI )with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated Symptoms of COPD: Subjects must score 2 or higher on the modified Medical Research Council Dyspnea scale (Visit 1) Pregnancy: Women who are pregnant or lactating Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they also have a current diagnosis of COPD) alpha 1-antitrypsin deficiency: Subjects with known alpha-1 antitrypsin deficiency as the underlying cause of COPD Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung resection or transplantation: Subjects with lung volume reduction surgery within the 12 months prior to Screening or having had a lung transplant A moderate/severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable) Current severe heart failure (New York Heart Association class IV). Subjects will also be excluded if they have a known ejection fraction of <30% or if they have an implantable cardioverter defibrillator (ICD) Other diseases/abnormalities: Any life-threatening condition with life expectancy <3 years, other than vascular disease or COPD, that might prevent the subject from completing the study End stage chronic renal disease: Subjects will be excluded if on renal replacement therapy (hemodialysis or peritoneal) Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroid) or components of the inhalation powder (e.g. lactose, magnesium stearate). In addition, patients with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.5-100.0, Staphylococcus Aureus Infection Cohort A: Participant or child of participant in the Agricultural Health Study Cohort B: Resident of Iowa Cohort A: Age < 8 months Cohort B: Age < 8 months | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 4.0-18.0, Ascaris Lumbricoides Ascaris Suum Trichuris Trichiura Trichuris Vulpis Ancylostoma Duodenal Ancylostoma Caninum Ancylostoma Ceylanicum Necator Americanus Subjects who are unable to provide a stool sample at follow-up Subjects who are experiencing a severe concurrent medical condition Subjects with diarrhea at first sampling | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 6.0-16.0, Serious Emotional Disturbance child has a Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis child at risk of psychiatric hospitalization due to serious out-of-control behaviors child resides in home of legal guardian, who is primary caregiver child insured by Medicaid score in the borderline clinical or clinical range on the Externalizing Scale of the Child Behavior Checklist (CBCL) referred to by a probation officer suffers from an unstable, chronic medical comorbidity prior receipt of | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-4.0, Pneumococcal Infections Infants Child has birth weight ≥ 2500g Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant Mother has resided in Burkina Faso for at least 2 years Mother has African nationality Child will reside in Bobo-Dioulasso urban area for the duration of the study Parent or guardian has given informed consent for child's participation Infants Child was born with a congenital abnormality Child has chronic or acute severe illness requiring specialized medical care Child has a blood coagulation disorder Mother has known HIV infection Child is enrolled in another clinical trial Child has known allergy to a component of the vaccine Child received a pneumococcal vaccine outside the context of the trial Child is 53 days of age or older at 6 week visit Child weighs <3500g at the 6 week visit Blood draw at 6 week visit was unsuccessful after 3 attempts | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.167-2.0, Bronchiolitis, Viral Home Nursing Age: 2-24 months, but age postconception of over 44 weeks Ac. bronchiolitis clinical diagnosis: acute respiratory illness including nasal congestion, coughing and wheezing or crackles simplified, Tachypnea or retractions of the chest X-ray confirms a viral diagnosis of bronchiolitis First attack of wheezing O2 Saturation < 91% room air while arrival to the ER The baby and his family have a way to return to the ER after discharge The family lives a distance of less than 30 minutes drive from the center of Emergency Medicine The baby lives in an environment with no smoking The baby's family is available by phone The baby's family is ready for continuous monitoring of the baby at home 11th. Disease severity index (RDSS) of < 4 (see definitions) Previous morbidity: cardiac, pulmonary, neuromuscular, nutrition (including FTT). And congenital or acquired airway problem Age since conception is less than -44 weeks History of apneas Bacterial pneumonia suggested by a localized-focal finding on X-ray Previous wheezing attack O2 Saturation > 92% on room air Family has no transportation available follow-up visits The family lives at a distance greater than 30 minutes drive from the medical facility The baby was treated with steroids for this attack There is no continuous monitoring of the baby at home | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 2.0-4.917, Influenza Healthy male or female child at least 24 months of age and no older than 59 months of age at the time of study vaccination A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Kamalapur surveillance site catchment area and who intends to be present in the area for the duration of the trial A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination Has any serious chronic disease including progressive neurologic disease, tuberculosis, Down's syndrome or other cytogenetic disorder, or known or suspected disease of the immune system Is receiving immunosuppressive agents including systemic corticosteroids during the two weeks prior to study vaccination Has a history of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations Is receiving aspirin therapy or aspirin-containing therapy currently or two weeks before Lives in household with somebody currently participating in a respiratory vaccination or antiviral study Has current or past participation (within 2 months of trial enrollment visit) in any clinical trial involving a drug or biologic with activity against respiratory disease Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 3.0-4.0, Children Under-nutrition Child is between 36 and 48 months of age Child has weight-for-height greater than or equal to 5th and less than or equal to the 25th percentile Child is capable of oral feeding Child's parent(s)or Legal Guardian is willing to abstain from giving additional non-study nutritional supplements to the child throughout the study period Child whose either parent has BMI greater than or equal to 27.5 kg/m2 Child allergic or intolerant to any ingredient found in the study product Child who was delivered pre-term Child was born small for gestational Child had birth weight < 2500 g or > 4000 g Child has current acute or chronic infections Child demonstrates presence of severe gastrointestinal disorders Child has a diagnosis of neoplastic diseases, renal, hepatic and cardiovascular diseases Child has a diagnosis of hormonal or metabolic disorders Child has a congenital disease or genetic disorder | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.25-4.0, Cystic Fibrosis Cystic Fibrosis participants laboratory diagnosis of Cystic Fibrosis Major organ system disease other than Cystic Fibrosis History of prematurity Non Cystic Fibrosis control participants Proof of a negative newborn CF screening test Major organ system disease History of prematurity | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 40.0-999.0, Acute Coronary Syndrome Recently (< 52 weeks) hospitalized for ACS Age < 40 years ACS event occurring more than 52 weeks prior to randomization visit LDL-C likely to be <70 mg/dL (<1.81 mmo/L) with evidence-based medical and dietary management of dyslipidemia | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Atrial Fibrillation patients with atrial fibrillation foreseen for Pradaxa anticoagulation according to physician's decision for stroke prevention patients with mild or moderate renal impairment age >= 18 years at enrollment severe renal impairment (Creatinine Clearance < 30 ml/min) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 5.0-999.0, Visceral Leishmaniasis Human African Trypanosomiasis Enteric Fever Melioidosis Brucellosis Leptospirosis Relapsing Fever Rickettsial Diseases HIV Tuberculosis Malaria Amoebic Liver Abscess fever for ≥ 1 week ≥ 5 years old (18 years onward in Cambodia) unwilling or unable to give written informed consent unable in the study physician's opinion to comply with the study requirements existing laboratory confirmed diagnosis need of immediate intensive care due to shock or respiratory distress | 1 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-30.0, Influenza Adults aged between 18-30 Presenting with symptoms of acute URTI (at least two among the following symptoms: body temperature ≥37.8°C, cough, rhinorrhea, sore throat, headache, myalgia/arthralgia) within 48 hours of illness onset being tested positive with a QuickVue rapid influenza test Allergic to paracetamol or any other antipyretics Have any underlying immunocompromized condition or be receiving immunosuppressive agents Have any history of chronic liver disease, or any active lung, heart or renal diseases requiring regular medication | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 2.0-5.0, Overweight Obesity In each of the three geographical areas (NC, CA, CT), two pairs of community-based child care centers in urban areas with English-speaking directors, kitchens, and with 50-60 children between the ages of 2 and 5 years, 35% of whom are eligible for subsidy If the randomly selected child care center has an open case of child abuse or neglect | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 50.0-999.0, Diabetes Diabetes Mellitus, Type 2 Type 2 diabetes Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors HbA1c (glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day One or more oral or injectable antidiabetic agent(s) An acute coronary or cerebrovascular event in the previous 60 days Planned coronary, carotid or peripheral artery revascularisation Chronic heart failure NYHA (New York Heart Association) class IV Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.25-16.0, Dengue Disease Progression Age >3 months and <16 years Clinical suspicion of dengue hemorrhagic fever. (Revised WHO Classification System) Not a prisoner or ward of the state Parents able and willing to give consent. Children older then 7 able and willing to give assent Allergic to Ultrasound gel Prisoners or wards of the state Unstable patients Known pleural effusion, ascites, or gallbladder wall thickening | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Informed Consent: A signed and dated written informed consent prior to study participation Type of subject: Outpatient Age: Subjects 40 years of age or older at Visit 1 Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD) Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded Other Respiratory tract infections that have not resolved at least 7 days prior to screening Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz [BfS]) Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.25-4.917, Pneumonia Children admitted with severe pneumonia as defined by the presence of all the following as defined as below months to 59 months old History of cough and/or shortness of breath Unwell for <= 7 days -Increased respiratory rate ( ≥ 50/min if ≤12 months old, ≥ 40/min) or retractions,- Any of the following signs/symptoms are present at examination that would necessitate admission: chest retractions, cyanosis, saturation< 92% on air, poor feeding or lethargy Documented fever (axillary /central temp ≥ 38/38.5°C) within 24 hrs of admission Abnormal CXR with presence of alveolar infiltrates Responds to IV antibiotics by the first 72 hrs and able to go home with oral antibiotics i.e. no more hypoxia and afebrile and reduced respiratory symptoms Children who (a) are transferred from another hospital (b) refuse blood taking (c) have a doctor diagnosis of asthma or recurrent wheezing illness (d) have a diagnosis of bronchiolitis i.e. wheezing in a child with a CXR with no consolidation (e) not acute illness ( ie >7 days) (f) unable to come for follow-up (g) not community acquired pneumonia e.g. aspiration pneumonia (h)complicated pneumonia with effusion, pneumothorax, clinical suspicion of necrotizing pneumonia (i)PICU admission or use of Non-invasive ventilation (j)significant comorbidities that can increase the risk of having a complicated pneumonia (k) need for use of other antibiotics like anti-staph or macrolides (l)extra-pulmonary infection e.g. meningitis (m)allergy to penicillin (n) unable to tolerate oral antibiotics (o) underlying illness that can predispose to recurrent pneumonia | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 2.0-999.0, Influenza Poultry-exposed individuals with poultry in the household willing to participate by signing a consent or assent form as appropriate for age, completing the study questionnaire, and permitting the withdrawal of blood, nasal washes, nasal swabs, and throat swabs Any known immunosuppressive condition or immune deficiency disease (including HIV infection), or ongoing receipt of any immunosuppressive therapy. (Note that we have chosen to such populations because of their increased risk of acquiring infections, they are relatively few, and are not representative of a national sample.) Terminally ill individuals Children who are less than 2 years old when baseline enrollment is performed | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Infant Behavior Child Behavior Parenting Child Rearing Depression Personal Satisfaction Behavioral Symptoms Social Control, Informal Baby is getting pediatric care at Bellevue Hospital Center or Pittsburgh Children's Hospital Caregiver primary language is English or Spanish Family can be contacted (has a working phone) Family attended second (follow-up) meeting with study team Birth weight <2500gm Gestational age < 37 weeks Not singleton birth (twin, triplet, etc.) Known or suspected significant genetic abnormality Known neurodevelopmental/neuromuscular disorder likely to affect development, movement, e.g., seizure disorder, microcephaly (low head circumference) Known sensory defect Known significant malformation likely to affect development or likely to require significant therapy Meets for Early Intervention at birth Significant postnatal complication requiring level II or III nursery stay. Examples: sepsis, significant hypoglycemia, seizures Mother with known significant impairment that will be barrier to communication and participation (e.g., intellectual disability, schizophrenia) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 0.0-999.0, Resident Education and Assessment of Difficult and High Acuity Scenarios That Focus on Cardiac Anesthesia Resident physicians who have completed at least one month of cardiac rotation are included.This high fidelity simulation lab course if offerred to every resident that meets the criteria.This is a part of their educational activity.At the beginning of the course they are given the option to participate in the survey.If they do not wish to participate in the survey it will not affect their education.Participitaion in the survey is purely voluntary Resident physicians that did not wish to participate in filling out the survey or not able to fill out the survey | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 5.0-999.0, Tenia Solium Infection Willing and able to participate in all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, and taking oral anthelmintic tablets (the latter specific for the elimination arm) Willing and able to provide informed consent (signature or thumb print with impartial witness; assent for minors with parental consent) Living in, attending school in, or regularly visiting the bore holes present in, the study communities Aged five years of age or older People without epilepsy Unwilling or unable to participate in some or all aspects of the study, including providing blood and stool samples, participating in a questionnaire survey and group discussions, or taking oral anthelmintic tablets (the latter specific for the elimination arm) Unwilling or unable to provide written (signature or thumb print with impartial witness) informed consent (or assent for minors) Living outside of, and not regularly visiting, or attending school in, the study communities Children aged four years or younger People with epilepsy (identified cases by the Rural Health Centre, questions included in the registration procedure) Seriously ill individuals (people unable to engage in the normal activities of daily living without assistance because of their illnesses) | 0 |
A 10 year old child is brought to the emergency room complaining of myalgia, cough, and shortness of breath. Two weeks ago the patient was seen by his pediatrician for low-grade fever, abdominal pain, and diarrhea, diagnosed with a viral illness, and prescribed OTC medications. Three weeks ago the family returned home after a stay with relatives on a farm that raises domestic pigs for consumption. Vital signs: T: 39.5 C, BP: 90/60 HR: 120/min RR: 40/min. Physical exam findings include cyanosis, slight stiffness of the neck, and marked periorbital edema. Lab results include WBC 25,000, with 25% Eosinophils, and an unremarkable urinalysis. | eligible ages (years): 18.0-999.0, Child Abuse Parenting for villages (n = 8) Situated within 1 hour driving distance from Shinyanga, Tanzania Provide community consent via community local leader and approval from local authorities Contain registered farmer groups for participating farmer groups (n = 16, 2 per village) Situated within participating village Registered with Tanzanian Ministry of Agriculture within the previous 3 years Registered to participate in ICS's Agribusiness and Skilful Parenting programme Provide consent via farmer group leader for adults caregivers (n = 240, 30 per village) for adult participants Any adult exhibiting severe mental health problems or acute mental disabilities Any adult that has been referred to social services or child protection services during the course of baseline data collection as a result of reported or observed indications of significant potential psychological harm towards a child for child respondents (n = 240, 30 per village) Age 10 to 17 years at initial assessment Lives in the house at least 4 nights per week Must have an adult primary caregiver who lives in the household, who provides consent, and who participates in the study Provides assent to participate in the full study for child respondents Any child who is either experiencing severe mental health problems, has acute developmental disabilities | 0 |