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An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.5-10.0, Community-acquired Pneumonia Children aged 6 months to 10 years presenting with CAP will be eligible. CAP will be defined if all of the four following numeric are met fever (>37.5 C axillary, > 37.7 C oral, or >38 C rectal) recorded in the ED or at home in the 48h prior to presentation any one of tachypnoea on exam (>60 bpm for age <1 y, >50 bpm for 1-2 y of age, >40 bpm for 2-4 y of age, and >30 bpm for >4 y of age) cough on exam or by history increased work of breathing on exam; or auscultatory findings (focal crackles, bronchial breathing, etc.) consistent with pneumonia infiltrates on chest radiograph consistent with bacterial CAP as judged by the ED physician; and the attending ED physician diagnoses the child with primary CAP. (Children treated with systemic steroids in the ED will be presumed to have primary asthma exacerbation with possible infection and therefore will not meet criteria.) Participants must be well enough to be treated as outpatients (discharged home by the ED physician, adequate volume status, able to tolerate oral medication, oxygen saturation > 90%, no evidence of impending respiratory failure), and have no evidence of empyaema or necrotizing pneumonia on chest radiograph Children will be excluded if they have any of the following: cystic fibrosis, anatomic lung disease, bronchiectasis, congenital heart disease, history of repeated aspiration or velopharyngeal incompetence, malignancy, conditions requiring treatment with immune suppressants, primary immunodeficiency, advanced HIV infection, prolonged admissions (>48 h) to hospital within the past 2 months, pneumonia previously diagnosed within the past month, lung abscess diagnosed within the past six months, receipt of > 24 hours of beta-lactam antibiotic therapy already received at presentation to the ED, receipt of at least a 5 day course of amoxicillin < 72h prior to presenting to the ED, receipt of an intravenous cephalosporin or azithromycin in the ED, or suspected allergy to penicillin. Children will not be eligible to participate more than once | 2 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-60.0, Rheumatic Dermatologic Disorders Informed Consent as documented by signature Indication for yellow fever vaccination according to Swiss FOPH recommendations Individuals under low dose MTX (≤20mg/week) therapy or healthy individuals Male and Female travelers ≥18 years to <60 years of age Contraindications on ethical grounds Women who are pregnant or breast feeding Contraindication against yellow fever vaccination (e.g. hypersensitivity against vaccine ingredient) Current treatment with other immunosuppressive agent apart from low dose methotrexate Alemtuzumab or rituximab in the last year TNF-blocking therapy in past three months Immunocompromising condition in healthy control Other immunocompromising condition than MTX treatment itself and the underlying disease in patients under MTX Previous yellow fever vaccination No indication for yellow fever vaccination according to Swiss travel vaccination recommendations | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Typhoid Fever Subjects are male or female aged ≥ 18 years at time of dosing Subjects are travelers attending travelers' vaccination clinics Subjects are eligible for typhoid vaccination, according to standard practice Subjects are expected to be able to provide follow-up information Subjects have an expected travel departure date more than 21 days after enrollment (to enhance follow-up by ensuring subjects remain in the US during the AE collection period) Subjects must sign a written informed consent Subjects with a known hypersensitivity to any component of the vaccine or the enteric coated capsule Subjects deficient in their ability to mount a humoral or cell-mediated immune response due to either a congenital or acquired immunodeficient state including treatment with immune-suppressive or antimitotic drugs Subjects with an acute febrile illness Subjects with acute gastrointestinal (GI) illness Subjects who are receiving medications with antibacterial activity (including proguanil) at the time of enrollment Subjects with other contraindications as determined by the site investigator | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Diarrhea Enteric Infection Soil-transmitted Helminth Infection Stunting Households in participating villages will be eligible to participate in the study if they have at least one child under 5 years | 0 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 0.0-999.0, Fever of Unknown Origin Tick-borne Diseases patients have fever more than one week temperature is higher than 38℃ Celsius degree full of physical examination and laboratory examination have been carried out after one week，but still cannot make a definite diagnosis fever for non-infectious diseases such as rheumatic autoimmune disease or with tumor we find that the patient selected does not meet the selection within the observation period patients leave with automatic discharge | 1 |
An 8-year-old male presents in March to the ER with fever up to 39 C, dyspnea and cough for 2 days. He has just returned from a 5 day vacation in Colorado. Parents report that prior to the onset of fever and cough, he had loose stools. He denies upper respiratory tract symptoms. On examination he is in respiratory distress and has bronchial respiratory sounds on the left. A chest x-ray shows bilateral lung infiltrates. | eligible ages (years): 18.0-999.0, Travel Medicine Receiving a pre-travel consultation at the Travel Health Network clinic in St. Albert, Alberta, Canada Travellers with an expected return date after September 1, 2016 Those receiving consultations as part of a group with the same itinerary (e.g., families, group vacations) will be asked to identify one member to participate in order to minimize repetition among participants | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 20.0-65.0, Whiplash Injuries Have whiplash injury following a motor vehicle accident in the prior 4 to 10 weeks | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Sleep Disorders Criteria:Drivers admitted as result of motor vehicle accidents - Drivers aged < 18 years | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-44.0, Alcohol Use Screen Positive for a drinking problem in the ED <18years or >44years old | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 30.0-60.0, Chronic Pain age driving licence driving experience normal vision right-handed fluently Dutch speaking psychological or physical disorder drug or alcohol abuse psychotropic medication use excessive smoking, drinking | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-80.0, Liver Cirrhosis Liver Disease Deceased donor livers allocated to adult (> 18 years of age) recipients at the research site Deceased donor livers allocated to recipients at centers other than the research site Deceased donor livers allocated to recipients < 18 years of age at the research site Non-heart beating donors Deceased liver and small intestine donors Live liver donors | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 21.0-75.0, Acute Mountain Sickness age 21 Height greater than 6'2", BMI greater than 45. Specified acute or chronic medical conditions - | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 15.0-16.0, Behavioral Intervention Teens between the ages of 15 years 0 months and 16 years 6 months enrolled in a licensed driver education course are eligible to participate Adolescents over the age of 16 years 6 months or those whose parent or legal guardian does not attend the driver education course session to which they are specifically invited will be deemed ineligible for the study | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 7.0-55.0, Learning Recruitment of teen participants will occur by arrangement with local driving schools in Montgomery County, VA Potential participants aged 16 or 17 who have held their driver's license for one month or less may be eligible Participants may be recruited during their training, and will only be eligible after they have met all requirements for licensure, and after both parental consent and teen assent are obtained If the teen wishes to participate, they must have their parent or legal guardian speak to the VTTI experimenter over the telephone for screening and then accompany the teen at an appointment so that the study can be explained and consent and assent provided Experienced adult drivers will be recruited via one-page recruitment fliers describing the study posted in the Blacksburg, VA area After an appointment is made, a telephone screening will occur using the Telephone Driver Screening and Demographic Questionnaire to assess age, sex, medical and driving history | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 15.0-45.0, Post Partum Haemorrhage For maternity units All maternity units belonging to one of the six perinatal networks of the study are eligible For women All women delivering at a gestational age greater than 22 weeks, in one of the participating maternity unit during the study period, will be eligible | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Visual Acuity Visual Disturbance Intraocular Pressure Male, aged 18 or older Scheduled for Robotic Prostatectomy Surgery ASA Classification of I, II, or III Good comprehension of written and spoken english Allergy to Tetracaine or related anesthetics Glaucoma Asthma History of heart electrical problems | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-60.0, Vasomotor Rhinitis (cases; n = 14 total; 10 with predominantly "physical" and 4 with predominantly "irritant"triggers) A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to Changes in temperature and/or humidity predominantly ("physical triggers"; n = 10); or Two or more nonspecific irritant triggers predominantly, including: perfumes or colognes,cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, etc. ("irritant triggers";n = 4). This history shall be of at least two years' duration (controls; n = 10) A significant history of chronic and/or recurrent nasal symptoms (rhinorrhea, blockage,sneezing or pruritus) in response to one or more nonallergic triggers, including: perfumes or colognes, cleaning products, environmental tobacco smoke, vehicular exhaust, paint odors, changes in temperature and/or humidity (all subjects; n = 24) A prior history of allergic disease (allergic rhinitis, asthma, angioedema, anaphylaxis) Significant skin test reactivity to one or more substances in a panel of 24 locally relevant seasonal and perennial aeroallergens Negative wheal response to positive control (histamine) on skin test panel Abnormalities on a screening x-ray (Waters view) of the paranasal sinuses Cigarette smoking (active, within previous 6 months or cumulative history of >20 pack years) Chronic cardiopulmonary diseases (asthma, COPD, coronary artery disease…) Continuous therapy with medications having antihistaminic or autonomic primary or secondary effects (e.g., oral or topical antihistamines, tricyclic antidepressants, ipratropium bromide, albuterol, alpha | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Infection Hospitalized men or women >/=18 years of age Expected duration of treatment with intravenous antibiotics anticipated to be >/= 5 full days but not exceeding 14 days Ability to provide documented and signed written informed consent Confirmed or suspected intra abdominal infection defined as follows For a confirmed intra abdominal infection, a surgical procedure (laparotomy or laparoscopy) must have been performed within 24 hours prior to enrollment and reveal at least one of the following Gross peritoneal inflammation with purulent exudates (i.e. peritonitis) Intra abdominal abscess Macroscopic intestinal perforation with localized or diffuse peritonitis Subjects enrolled on the basis of a suspected intra abdominal infection must have Radiological evidence [abdominal plain films, computed tomography (CT), magnetic resonance imaging (MRI) or ultrasound] of gastrointestinal perforation or intra-abdominal abscess and the following signs and symptoms Known hypersensitivity to quinolones, and/or to carbapenems and/or to any other type of beta lactam antibiotic drugs (e.g. penicillins or cephalosporins), or any of the excipients Women who are pregnant or lactating or in whom pregnancy cannot be excluded History of tendon disease/disorder related to quinolone treatment Known congenital or documented acquired QT prolongation; uncorrected hypokalemia; clinically relevant bradycardia; clinically relevant heart failure with reduced left ventricular ejection fraction; previous history of symptomatic arrhythmias Concomitant use of any of the following drugs, reported to increase the QT interval: antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhythmics class III (e.g., amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressive agents, certain antimicrobials (sparfloxacin, erythromycin IV, pentamidine, antimalarials, particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), and others (cisapride, vincamine IV, bepridil, diphemanil) Known severe end stage liver disease Creatinine clearance </= 30 mL/min/1.73 m2 Systemic antibacterial therapy administered for more than 24 hours within 7 days of enrollment Need for systemic antibacterial therapy with agents other than those described in the study protocol Indwelling peritoneal catheter | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-25.0, Attention Deficit Hyperactivity Disorder ADHD diagnosis Valid driver's license Not taking any medication for their ADHD Have access to a car of which they are the primary driver Have a history of approximately two driving collisions or citations Have a history of responsiveness to methylphenidate Older than 25 years of age Bi-polar disease Psychosis Satisfy the DSM IV of active depressive or anxiety disorders Have any medical condition that might impair driving or be contra-indicated for the use of methylphenidate Pregnant or intending to get pregnant for the duration of the study,breastfeeding or intending to breastfeed for the duration of the study Have skin allergies or skin condition that could be exacerbated by wearing the medication patch Have documented allergy, hypersensitivity, or intolerance to methylphenidate Have documented hypersensitivity to the Daytrana® adhesive backing Have (history of) | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 25.0-60.0, Cognitive Measures Driving Simulator Performance Anticipating a 10-15% drop-out rate, we will induct 30 neurologically normal subjects (age 18 (21) -60) to obtain 25 evaluable subjects who are legally licensed to drive in their state of residence and have been actively driving under appropriate legal guidelines for at least 5 years (to minimize performance variations of novice drivers) Because this study is intended to determine the potential effects of phenytoin on driving performance, a relatively healthy cohort of patients must be chosen. Chronic medical or psychiatric conditions could cause significant alterations in driving performance independent of those caused by phenytoin, which would complicate interpretation of performance impairments Subjects who are younger than 18 or older than 60 Have history of prior seizures, family history of epilepsy, or prior history of head injury Have a known history of prior drug or alcohol abuse or unwillingness to abstain from drug or alcohol use during the study period Have a past or current active neurological or psychiatric disorder that could impair cognitive or driving performance (i.e. baseline IQ < 90, dementia, mental retardation, stroke, severe head injury, schizophrenia, active clinical depression, progressive brain tumor) Subjects who have a chronic medical condition (i.e. diabetes mellitus, renal insufficiency, congestive heart failure, hepatic dysfunction, hematologic condition, HIV) Taking medications known to affect the central nervous system (i.e. baseline pre-study treatment with antiepileptic drug, anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, narcotics and tranquilizers) Regularly use over-the-counter cough suppressants, antihistamines, or sleep aids; or who ingest over 7 cups of daily coffee or currently smoke cigarettes Subjects will be excluded if they cannot complete SIREN testing or neuropsychological instruments because of visual or hearing impairment (history or screening discovery of corrected visual acuity of less than 20/50) or other physical disability, or if they have a history of severe motion sickness as an adult—a marker for patients who develop simulator sickness and therefore cannot participate in SIREN testing | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-999.0, Abdominal Pain All consecutive emergency department patients undergoing abdominal CT for non-traumatic abdominal pain and tenderness will be prospectively enrolled, with the following exceptions. For study purposes, "abdominal pain and tenderness" is defined as pain and tenderness to direct palpation in the region anterior to the mid-axillary line bilaterally, and extending from the costal margins to the inguinal ligaments. Consequently, patients undergoing CT for indications such as isolated vomiting, fever without source, staging of malignancies, isolated flank pain or suspected renal colic, or other indications that do not meet the above definition will not be enrolled Pregnant women do not routinely undergo abdominal CT due to radiation concerns and will be excluded from the study Patients with altered mental status or altered abdominal sensation (due to neurological conditions such as paraplegia) that may prevent assessment of the location of abdominal tenderness will be excluded Preverbal children will be excluded as they rarely undergo CT and will be unable to indicate the region of maximal tenderness | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Humeral Fractures Multiple Trauma age > 18 years patients with past (acute) traumatic humeral shaft fracture(s) treated with open reduction and internal fixation (ORIF) patients for whom the above fracture has healed patients willing and able to provide informed consent and able to participate in study procedures patients with known pathological fractures patients with metabolic bone disease patients with humeral head or inter-articular surface fractures, or other upper extremity fractures patients with previous humeral surgery (i.e. rotator cuff, biceps tendon, etc.) patients with neurologic injury to upper extremities | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 50.0-999.0, Osteoporotic Vertebral Fracture Between T5 and L5 Chronic Arthritis, Longer Than Six Weeks Duration Patient is able to undergo the vertebroplasty or Balloon kyphoplasty procedure Patient has read and sign the informed consent Male or female, 50 years or older One or two non-traumatic vertebral fracture(s) Of osteoporotic origin (low speed trauma such as fall from his own height or less than 80 cm) Fracture(s) older than 6 weeks duration after the onset of pain related to the fracture· The fracture(s) exhibit(s) high signal intensity on T2-weighted images and a benign appearance at MRI Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment The patient will be able to receive the selected protocol treatment within 15 days after treatment randomization The benign nature of the vertebral fracture has to be confirmed by the results of the biopsy performed during vertebroplasty or balloon kyphoplasty Patient with a vertebral fracture of less than 6 week duration after onset of fracture-related symptoms Neurological signs related to the vertebral fracture to treat History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain Patient with more than 2 fractures corresponding to the (old fractures are not taken into account) Known allergy to a contrast media or to one of the cement components used for kyphoplasty More than two recent vertebral fractures Current infection Impossibility to perform the percutaneous approach of the vertebra to treat Known allergy to a contrast media or to one of the cement components used for kyphoplasty Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, One or Two Traumatic Vertebral Fractures Located Between T11 and L5, Balloon Kyphoplasty Preliminary clinical examination (the anaesthesist must have provided his approval for the surgical procedure) Patient must have signed the consent form Male or female patient aged 18 or over One or two traumatic vertebral fractures located between T11 and L5 and type A3.2, A3.3, B1 or C1 in the classification, and with a regional kyphotic angle > 15° and treated by osteosynthesis through a posterior surgical approach with or without spinal decompression Fracture with or without neurological difficulties Non tumoral origin: Confirmed by biopsy at the same time of the Balloon Kyphoplasty procedure Non traumatic, malignant or osteoporotic vertebral fractures History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain Known allergy to a contrast media or to one of the cement components used for kyphoplasty More than two recent vertebral fractures Current infection Impossibility to perform the percutaneous approach of the vertebra to treat Reduction by more than 50% of the anteroposterior width of the bony spinal canal due to the vertebral fracture to treat Vertebral fracture with loss of 90%or more of the vertebral body height Patient presenting a non correctable spontaneous or therapeutic coagulation disorder | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Post-Traumatic Stress Disorder Primary diagnosis of post-traumatic stress disorder Involved in motor vehicle accident that occurred at least 3 months ago Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression History of psychosis Active suicidality or history of two or more suicide gestures or attempts in the past year Significant cognitive impairment Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 16.0-60.0, Sprains and Strains Age 16-60 years Onset of ankle sprain at least 2 weeks prior to enrollment Foot and Ankle Ability Measure Activity of Daily Living subscale score less than or equal to 80% Current status of assisted ambulation (eg, use of cane or crutches) Inability to bear weight through the affected extremity immediately after injury combined with tenderness to palpation of the medial and lateral malleolar zones, styloid process of the 5th metatarsal, and navicular Positive anterior drawer or talar tilt dimple test Volume of the affected limb greater than 10% of the unaffected limb Previous history of ligament or bony reconstructive surgery to the ankle and foot Concomitant injury to other lower extremity joints | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Rib Fractures Subjects must be at least >18 years of age Subjects must have one of the following clinical indications >3 rib flail segments with paradoxical chest wall movement Non-repair of defect may result in pulmonary hernia Minimal associated injuries Severely displaced fractures are significantly impeding lung expansion Failure of narcotics or epidural pain catheter to control pain Significant pulmonary contusion Significant brain injury (AIS 4 and/or ICP monitoring) Severe associated injuries which, in the opinion of the surgeon will preclude operative chest wall stabilization Subjects not expected to survive the 90-day follow-up period Known pregnancy Prisoners | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-80.0, Whiplash Injuries Patients have had a measurement of the cervical range of motion | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 21.0-35.0, Driver Sleepiness He/she is aged between 21 and 35 years old BMI between 21 and 30 85 kg body weight Non smoker Written informed consent Normal static binocular acuity, corrected or uncorrected Normal hearing Possession of a valid driver's license for at least 3 years Regular driver (> 5000 km / year) Be considered as reliable and mentally capable of adhering to the protocol Current drug use (positive urine drug screen on the presence of amphetamines (including MDMA), barbiturates, cannabinoids, benzodiazepines, cocaine, and opiates) as will be assessed by a urine drug test Use of psychoactive medication Pregnancy Positive alcohol breath test Prior enrolment in the same study Physical or mental illness Excessive alcohol use (>21 alcoholic drinks per week) Intake of caffeine-containing beverages under 2 or over 4 glasses per day Regular consumption of Energy Drinks (>1 per month) Shift worker (or no regular sleep pattern) | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Open Abdomen Trauma patients with open abdomen after initial laparotomy Emergency surgery patients with open abdomen after initial laparotomy Able to obtain consent from patient or LAR before any research initiated Seprafilm application at initial laparotomy Patient is a prisoner Inability to obtain informed consent Consentable person does not speak English | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-80.0, Surgical Complications Relaparotomy Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas) Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen Patients with signs of sepsis in the post operative period Patients with signs of systemic hypoperfusion in the post operative Liver surgery Drainage of bile, blood and dejection from abdominal drainage Sepsis/ systemic hypoperfusion due to extraabdominal infection site | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 20.0-55.0, Spinal Cord Injuries Must be able to give voluntary (patients may not be able to write) consent Must be able to understand study information provided to him Patients with complete spinal cord trans-section: at least post 6 months after spinal cord Injury (in chronic patients), < 2 weeks in acute category and 2-8 weeks in subacute patients The level of spinal cord injury must be between C4 and T12(neurological level) Spinal cord injury categorized in terms of ASIA Impairment scale Age should be between 20-55 years Mechanical ventilation due to neurological impairment Multiple level trauma Undetermined size and location of Spinal Cord injury Gunshot or other penetrating trauma to the spinal cord Longitudinal dimension of injury by MRI is greater than 3spinal segments Associated severe head injury More than 9cms long bone fracture Women who are pregnant or lactating Serious pre-existing medical conditions Disease or impairment that precludes adequate neurological examination | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Stress Disorders, Post-Traumatic Stress Disorders, Traumatic, Acute Road traffic accident victims hospitalized in surgical department less than 2 weeks Can be called by phone Patient with a coma for more than 15 minutes Patient with a crania traumatism and with loss of consciousness over 15 minutes Homeless | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-999.0, Intestinal Disease Feeding Disorder Neonatal Birth gestational age (GA) between 25 and 32 weeks Corrected gestational age less than 34 weeks Enteral feeding tolerated at a minimum of 10 ml/kg/day for a minimum of 48 hours Severe feeding intolerance, defined as a minimum of one or more of the following signs leading to withholding of milk feedings on two evaluations over 12 to 24 hours Significant increased abdominal girth, as evaluated by the treatment team, with abdominal tenderness Visible enlarged bowel loops with abdominal tenderness Recurrent emesis leading to withhold feeds Gastric residuals in excess of one feeding, recurrent or with growing abdominal girth Visible blood in stools without anal etiology Documented informed consent for participation in the study Infants who already reached full enteral feeds for 72 hours, in fact a minimum of 130 ml/kg/day enteral feeds without parenteral supplementation Small for gestational age (SGA) (weight at or less than the 3rd percentile on the Fenton growth chart) NEC (Bell's stage II or higher, radiologic evidence of NEC, pneumatosis intestinalis or free intraperitoneal air)or history of NEC Gastric or intestinal occlusion (no transit, absent bowel sounds, incessant vomiting, bile stained vomiting or air fluid levels) Major congenital malformation Septic infants requiring therapeutic antibiotics or antimycotics (infants only on prophylactic antibiotics or antimycotics should not be excluded) Patients judged as being too ill to enroll in this study, as defined by a requirement for mechanical ventilation with >50% FIO2 Patent Ductus Arteriosus requiring ibuprofen, indomethacin or ligature, until one week after the end of treatment Intraventricular Haemorrhage grade 3 or 4 Hypernatremia ≥ 150 mmol/L | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis Adult patients requiring a CT abdomen for clinical purposes will be included Pediatric patients | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 25.0-35.0, Automobile Driving Male Caucasian ethnicity Age 25-35 years Possession of a driver's licence for at least five years Score ≥ 2 on the modified Apfel-scale to assess risk for motion sickness(*) History of driving under the influence of alcohol and/or illicit substances History or presence of alcohol or illicit drug abuse Former abnormal reaction to any hypnotic drug History of strong averse reactions to blood sampling procedures Regular (daily) intake of any prescribed drug, or intake of grapefruit juice or herbal remedies that can influence the metabolism of zopiclone (e.g. St John's wort) History of severe allergic reactions, or significant mental, cardiovascular, renal or hepatic disorder, or other significant disease as judged by the investigators Detection of any drugs of abuse on pre-session urine drug screening (*)Modified Apfel-criteria for prediction of postoperative nausea/vomiting Smoker? yes 0, no 1 | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 6.0-18.0, PTSD Traumatic Brain Injury Post Concussive Syndrome For the whole sample Children age 6 to 18 Language spoken: Hebrew, Arabic DSM IV R diagnosis: PTSD Car accident event within past 3 years For the m-TBI group Any of the following symptoms or experiences occurring during or shortly after the accident: loss of consciousness, dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), visual loss, abdominal pain] Diagnosis of MTBI within 3 years as confirmed by CT/MRI/fMRI Glasgow coma scale; GCS<15 Children presenting with psychotic symptoms Children presenting with mental retardation | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 16.0-999.0, Trauma Teenagers perceived to be students driving near school property Teenagers perceived to be of driving age Teens in 10th, 11th, and 12th grades attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools Any driver driving near school property, which is perceived to be older than of high school age Teenagers perceived as non-attendees of the nearby school Teenagers perceived not to be of driving age Teens not in 10th, 11th, and 12th grades, or not attending Phillipsburg, Southern Lehigh, Freedom and Liberty High Schools Any driver who does not meet the above criteria | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-60.0, Intraarticular Fracture and Post-traumatic Osteoarthritis years of age or older Radiographic evidence of tibial plateau fracture Less than 18 years of age Greater than 60 years of age Any history of pre-existing knee osteoarthritis based on previous diagnosis or suggestive history Any history of autoimmune disease Any history of contralateral intra-articular knee injury | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 45.0-74.0, Postmenopausal Disorder Blood Pressure Over Weight Woman between 45-74 years of age Have not had a menstrual period for at least 12 months Are not regularly physically active (self-reported non-exerciser for previous 6 months) Have a body mass index (BMI) between 25-45 kg/m2 Have high normal blood pressure or (systolic pressure of 130-179 mmHg or a diastolic pressure of 85-99 mmHg) Not limited in your ability to walk Understand these Are willing to provide informed consent Willing to be randomized to either type of walking intervention or a control group being studied, and are willing to follow the protocol for the group to which they have been assigned Have a past history and/or physical examination or laboratory findings of a medical condition including (but not limited to) Have any medical condition or disease that is life-threatening or that can interfere with or be aggravated by exercise Have been diagnosed with diabetes Blood pressure is greater than 179 mmHg systolic or 99 mmHg diastolic Participating in another research study which may effect the results of WalkMore | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-18.0, Abdominal Injuries Blunt torso trauma resulting from a significant mechanism of injury Motor vehicle collision: greater than 60 mph, ejection, or rollover Automobile versus pedestrian/bicycle: automobile speed > 25 mph Falls greater than 20 feet in height Crush injury to the torso Physical assault involving the abdomen Decreased level of consciousness (Glasgow Coma Scale score < 15 or below age-appropriate behavior) in association with blunt torso trauma Blunt traumatic event with any of the following (regardless of the mechanism) Extremity paralysis Multiple long bone fractures (e.g., tibia and humerus fracture) No concern for inter-abdominal injury or no planned evaluation for possible IAI Prehospital or ED age adjusted Hypotension Prehospital or initial ED GCS score ≤ 8 Presence of an abdominal "seat belt sign" continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt Penetrating trauma: stab or gunshot wounds Traumatic injury occurring > 24 hours prior to the time of presentation to the ED Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-70.0, Type 1 Diabetes Hypoglycemia Have been diagnosed with Type 1 diabetes for at least one year Started taking insulin less than a year after being diagnosed with Type 1 diabetes Measure blood glucose at least twice a day Legal and valid driver's license Drives greater than 5,000 per year Regular access to the Internet, either through family computer or another readily accessible computer Age 18 years English speaker Type 2 diabetes Does not take insulin Does not drive Does not have legal and valid driver's license Does not have routine access to the internet | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-89.0, Open Abdominal Wounds Abdominal Adhesions Wound Sizes Trauma Population Trauma patients undergoing DC/OA management for traumatic injury Age 18+ Life expectancy longer than 48 hours Prisoners Pregnant patients Younger than 18 years of age | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-0.615, Postnatal Growth Disorder Neurodevelopment Gestational age < 32weeks (maternal dates or early fetal ultrasound) Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and Written informed consent has been obtained from the infant's legal representative Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities Babies with enterostoma or short gut syndrome Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis Bell Stage 2; air in the biliary tract or free air in the peritoneum Bell Stage 3) Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80 Hepatic dysfunction, defined by jaundice (direct bilirubin >1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT) Participation in another clinical trial that may affect outcomes of this study; or Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Cardiovascular Disease employee of Washington University in St. Louis pregnancy | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 65.0-999.0, Geriatric Hip Fracture Pain Management Both sex of Age > 65 Traumatic non-pathological fracture neck of femur or trochanteric or subtrochanteric fracture having operative intervention Age < 65 Pathological fracture Multiple lower limb fractures Old fracture | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 19.0-65.0, Diagnostic Colonoscopy Screening Aged 19-65 years American Society of Anesthesiologists physical status (ASA PS) 1-2 Patients scheduled for elective colonoscopy under Monitored Anesthesia Care in a University Hospital Patients who signed on written informed consent The are refusal or inability to provide written informed consent Age < 18 years Pregnancy Previous large bowel surgery Psychiatric disorders History of addiction to opiates and / or sedatives, and previous adverse reaction to any drug used in the study | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 20.0-999.0, Post ERCP Pancreatitis Consecutive patients were recruited for the study who presented to the Yonsei University Medical Center with variable symptom or cause for ERCP older than 20 years Patients were excluded from study participation if they had a contraindication for diclofenac including patients with recently diagnosed peptic ulcer disease or active/recent gastrointestinal hemorrhage within 4 weeks renal failure (Cr > 1.4) those who had taken an NSAID during the preceding week (ASA 325 mg daily or less acceptable) those who developed acute pancreatitis during the 2 weeks before ERCP those with a history of chronic calcific pancreatitis or allergy to aspirin or NSAID, and those who did not agree intramuscular injection. Additionally, if state of patients was intrauterine pregnancy or breast feeding mother, they were excluded. Finally, patients were excluded for study if they had bleeding tendency and contraindication for intramuscular injection | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Proximal Humeral Fractures traumatic fractures of the proximal humerus surgical treatment over eighteen years of age pathological fractures conservative treatment soft tissue damage delay of surgery more than three days immunological defects multiple trauma | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-80.0, Pain Female 80 years of age TMJ arthralgia Masticatory myalgia TMJ sounds History of at least 6 weeks use of occlusal appliance therapy Contraindication to sedation including pregnancy or medical history History of previous TMJ procedure including arthrocentesis, arthroscopy or arthrotomy History of steroidal injection into TMJ History of trauma to TMJ TMJ pain longer than 3 years History of narcotic drug use on a scheduled basis Current active infection | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 3.0-60.0, Blunt Abdominal Trauma 3-60 years of age evaluated for blunt trauma with a GCS of >14 Order of CT abdomen and pelvis imaging Patients requiring intubation or suspected neurological injury (defined above) Pregnant patients Intoxicated patients Patients with age defined hypotension Exploratory laparotomy or transfusion during the ED evaluation Non-verbal patients Positive FAST exam Patients with abdominal trauma or surgery in the last month Victims of sexual assault or non-accidental trauma (NAT) Patients with known or suspected fractures of the femur or pelvis prior to CT imaging | 2 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-98.0, Trauma to the Abdomen All patients with a post-injury open abdomen Patients to be excluded from analysis deaths within 24 hours, identification of injury > 24 hours, and those transferred from an outside hospital > 24 hours following initial injury | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 13.0-999.0, Open Abdomen Temporary Abdominal Closure Mechanisms Open Abdomen Patients that die in the first 48 hours after the initial intervention | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Spinal Cord Injury Orthostatic Hypotension inpatients positive diagnosis of OH acute traumatic SCI lesion level above T6 AIS A, B or C fractures of the lower limbs decubitus (NPUAP >2) massive psychiatric dysfunction suicide intention | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 20.0-85.0, Osteoporosis (1) Patients who are currently taking or plan to take oral glucocorticoid medication for 3 months or longer and thus require treatment as per the 'Guidelines on the management and treatment of glucocorticoid-induced osteoporosis of the Japanese Society for Bone and mineral Research (2004),' and who meet at least one of the conditions below. No restriction is imposed on the underlying disease treated with the oral glucocorticoid medication (i) Have any existing insufficiency fracture (ii) %YAM <80 (iii) Oral glucocorticoid daily dose >= 5 mg prednisolone equivalent (2) Aged between 20 and 85 years (both inclusive) at consent (3) Patients who are able to walk without assistance (4) Provided consent to participate in the study (1) BMD (L1-4 or T-Hip) T score < -3.5 (2) Have 3 or more vertebral fractures between L1 and L4 (3) Have 1 or more SQ grade 3 vertebral fractures, or 3 or more SQ grade 2 vertebral fractures (4) Have received a bisphosphonate preparation for 2 weeks or longer within 6 months before the start of study treatment (5) Have received a bisphosphonate preparation for 2 years or longer within 3 years before the start of study treatment (6) Have received a parathyroid hormone preparation before the start of study treatment (7) Have received one or more doses of an anti-RANKL (receptor activator of nuclear factor-kappa B ligand) antibody (8) Have received one or more doses of an anti-sclerostin antibody or cathepsin K inhibitor (9) Have received any other investigational product (including placebo) within 16 weeks before the start of study treatment in the present study (10) Have received any of the following drugs that can affect bone metabolism within 8 weeks before the start of study treatment, with the exception of calcium preparations: (i) Bisphosphonates (ii) Active vitamin D preparations (including those for topical use) (iii) Selective estrogen receptor modulators (SERMs) (iv) Calcitonin preparations (v) Vitamin K2 preparations (vi) Ipriflavone preparations (vii) Reproductive hormone products (except those for vaginal use such as vaginal tablets and creams) (viii) Other drugs that can affect bone metabolism | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Non-arteritic Anterior Ischemic Optic Neuropathy Decreased Vision Due to Ocular Trauma Multiple Sclerosis You are 18 years or older You have sustained trauma (more than 3 months before this study) OR been diagnosed with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) (more than 6 months before this study) OR been diagnosed with Multiple Sclerosis (MS) and suffered visual loss (more than 3 months before this study) You are willing and able to give written informed consent You are able to commit to enrolling in the study during the full time period of up to 6 months You have any other significant ophthalmologic disease or condition (such as glaucoma, retinal degeneration, proliferative diabetic retinopathy, +/ six diopters of myopia, retinal detachment, exudative age-related macular degeneration) You have amblyopia (lazy eye) in affected eye, previously diagnosed You are participating in any other interventional clinical trial If you are pregnant OR a woman with childbearing potential who is unwilling to use medically acceptable means of birth control for study duration OR woman unwilling to perform a pregnancy test at study entry/screening You are unable to give signed consent due to memory, medical, communication, language, or mental health problems You are less than 18 years old You are unable or unwilling to complete the evaluation or questionnaire Visual acuity better than 20/40 Inability to detect phosphenes during threshold detection | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 15.0-49.0, Hypertension, Pregnancy Induced Hydralazine Adverse Reaction Pre-eclampsia Pre-eclampsia Superimposed Pre-existing Hypertension Pregnant or post partum patients with systolic blood pressure ≥160mm of Hg or diastolic BP ≥110 mm Hg, on repeat measurement of blood pressure after 15 minutes of rest, meeting following will be included Pregnancy greater than 28 wks(gestational age determined by ultrasound prior to 20 weeks which if unavailable then by uterine size at first prenatal visit or by last menstrual period) with gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension Postpartum patients, upto 72 hours after delivery, diagnosed as gestational hypertension, severe preeclampsia, chronic hypertension, chronic hypertension with superimposed preeclampsia, eclampsia and unclassified hypertension Patients with singleton or multiple pregnancy Patients of all ages and parity Patients with asthma Patients with cardiac failure and heart block Patients with pacing device in place or any type of cardiac arrhythmia. - | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 16.0-999.0, Hemorrhagic Shock Age ≥16 years of age or estimated weight ≥50kgs if age is unknown Victim of blunt or penetrating trauma Hemorrhagic shock defined as One or more episodes of systolic blood pressure ≤90mmHg at any time prior to enrollment into the study An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury Application and completion of RIC within 4 hours of the injury Pregnancy Non-hemorrhagic shock (i.e. tension pneumotorax, cardiac tamponade, spinal shock, etc.) Burns Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours Patients requiring immediate transfer to operating room for definitive management will be excluded in order to prevent delay in their treatment | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-65.0, Injuries, Whiplash victims of motor vehicle accidents signed informed consent pregnancy traumatic brain injury psychiatry disorders active cancerous conditions adrenal diseases medical treatment by estrogens, anti-depressants, melatonin, pain control substance abuse hospitalization due to the trauma contra indication to hydrocortisone treatment over 6 hours from time of injury | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Postoperative Pain Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above Ability to read and understand Danish and give informed oral and written consent Multitrauma patients / other simultaneous fractures Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol "CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason Primary investigator unavailable for PNB administration at scheduled time of operation Infection at PNB injection site Time from fracture to operation > 5 days Existing neuropathy with functional impairment of the fractured extremity Bodyweight < 50 kg Daily use of opioids > 2 weeks preoperatively Pregnancy | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-0.25, Transfusion Feeding During Transfusion Transfusion Related Acute Gut Injury Necrotising Enterocolitis <32 weeks of gestational age or <1500 gr, >7 days old premature babies Babies which are fed enterally well at the time of tha planning of transfusion Babies with severe sepsis signs Babies with severe hypoxia and asphyxia Babies with congenital anomaly or complex cardiac anomaly | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Intradialytic Hypotension Must be able to give informed consent for participation in this study Age ≥ 18 years A body weight > 100 lb or a body mass index > 18.5 End-stage renal disease with hemodialysis in-center three times per week Not missing any treatments in the preceding two weeks and in compliance with instructions from the health care provider In the last month had at least two episodes of IDH (defined as having hypotensive symptoms such as dizziness, fainting, headache, nausea, vomiting, cramping, weakness, blurry vision and/or a decrease in systolic blood pressure (SBP) of more than 20 mmHg) Hemoglobin greater than or equal to 9.0 g/dL (hematocrit 27%) to hemoglobin of 15.0 g/dL (hematocrit 45%) • Pregnancy (self-reported) Allergic to nylon, polyesters and latex Not able to understand the English language Not able to disengage the ACES from compression Having an excessively low systolic blood pressure (SBP which is less than 90 mmHg) Hemoglobin less than 9.0 g/dL or greater than 15 g/dL Excessive intra-abdominal fluid pressure Respiratory distress Bleeding in the chest and abdomen Bleeding dyscrasia causing serious coagulation problem | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 21.0-80.0, Stroke first-time unilateral cerebral stroke a stroke at least 6 months prior to enrollment gait asymmetry, but able to walk independently no evidence of uncompensated hemianopsia, tested by using Pedretti's method (Pedretti 1985) no evidence of severe (greater than 16 in the Folstein Mini-Mental Status Exam) cognitive impairment (Folstein et al. 1975) or language dysfunction that would interfere with understanding the instructions no evidence of neglect, tested by being asked to copy a simple drawing of a house (Gregory and Aitkin 1971) unable to walk at least 0.3m/s orthopedic or pain conditions history of seizure disorders metal implants (stents, clips, pacemaker) pregnancy any condition that makes balance unstable require a walker to walk uncorrected visual impairments | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Thoracoabdominal Trauma Focused Assessment With Sonography for Trauma (FAST) NanoMaxx Ultrasound System (SonoSite) RP-Xpress (InTouch Technologies) for FAST cohort Patient is 18 years of age or older Patient presenting with blunt or penetrating trauma to the thorax or abdomen Patient transported by MD Ambulance to Royal University Hospital Patient being transported by a paramedic who has received training in the above ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be used in connection with the RP-Xpress (InTouch Technologies) Patient will take longer than 10 minutes to transport to hospital Patient's care will not be compromised in completing a FAST exam opinion of paramedic Patient's care will not be compromised in completing a FAST exam opinion of ER physician Patients under the age of 18 Patients whose care would be compromised if other procedures of higher priority (as determined by paramedics and/or remotely-present physicians) were not be able to be executed due to time involved in completing a FAST exam Patients who are not being transported to Royal University Hospital Patients whose expected transport time from scene to hospital is less than 10 minutes | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Trauma Injury Bleeding Haemorrhage Coagulopathy Injured trauma (penetrating or blunt) patients who are at risk of significant bleeding, defined as: i. Systolic blood pressure (SBP) ≤ 100mmHg at any time from the injury scene until 30min after hospital admission AND ii. Red blood cell transfusion has been ordered by the trauma team leader (or delegate) Patients in shock which the etiology is purely not related to bleeding i. Cardiogenic (myocardial or valvular dysfunction); ii. Distributive (septic, anaphylactic, acute adrenal insufficiency and neurogenic) and iii. Obstructive (cardiac tamponade, tension pneumothorax and massive pulmonary emboli) Severe head injury, defined as any of the following i. Glasgow coma scale (GCS) of 3 due to severe traumatic brain injury (TBI); ii. TBI with clear indication of immediate neurosurgical intervention based on clinical findings (mechanism of trauma associated with focal signs such as anisocoria with fixed pupil) or on CT results (bleeding causing mass effect); iii. Unsalvageable head injury such as through-through gunshot wound to the head, open skull fracture with exposure/loss of brain tissue; as per the trauma team or neurosurgery initial clinical assessment or as per initial CT of the head findings Known complete or incomplete spinal cord injury Known hereditary or acquired coagulopathies unrelated to the trauma resuscitation (e.g. known hepatic dysfunction) Use of anticoagulant medications such as warfarin, low-molecular weight heparin, and direct thrombin and factor Xa inhibitors Moribund with evidence of unsalvageable injuries and withdrawal of care, as per the trauma team Received blood products prior to admission Patients with estimated body weight under 50Kg | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-70.0, Infection Is male or female, 18 to 70 years of age Has provided written informed consent Has experienced abdominal trauma, blunt or penetrating requiring open abdominal laparotomy with primary closure or acute surgical abdomen requiring open abdominal laparotomy with primary closure Undergoes the required surgical procedure within 36 hours of presentation to the healthcare system Known allergy to Chlorhexidine Gluconate (CHG) Abbreviated Injury Scale (AIS) score of six (6) American Society of Anesthesiologists Physical Status Classification (ASA) score of five (5) or greater Female volunteers who are pregnant and/or breast feeding Damage control laparotomy Drain is placed within the wound or an intra-abdominal drain exits through the incision Reoperation occurs through the same incision or transgresses the same incision as the index procedure within 30 days Abdomen opened prior to operating room Currently enrolled in a clinical trial | 1 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 14.0-19.0, Concussion • Normal healthy volunteer Able to provide written consent Must be 14 years or older and a participant on a competitive and organized sports program Neck circumference of 15 ½ ½ inches • Unable to provide written consent History of neurological deficits, previous cerebral infarction, or severe head trauma Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis) Glaucoma (Narrow Angle or Normal Tension) Hydrocephalus Recent penetrating brain trauma (within 6 months) Known carotid hypersensitivity Known increased intracranial pressure Central vein thrombosis Any known airway obstruction | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-90.0, Pain Fracture Patients at least 18 years old Male or Female All racial and ethnic groups Fractures and fracture/dislocations of the foot, ankle, tibia, fibula, elbow, forearm, wrist and hand Patients who opt for surgical treatment of their fractures Patients who consent to be randomized Patients who are willing to follow-up for a minimum of 52 weeks Patients younger than 18 years old Patients who are on chronic opioids Patients who abuse opioids Patients who are unwilling to follow-up for a minimum of 52 weeks Neurologic condition that could interfere with pain sensation | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-65.0, Injuries The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. Parents or legal guardians could potentially be as old as 65 or older Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained online | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-999.0, Injuries Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital Parent or guardian of child 4-7 years English speaking Have and Android or iPhone smartphone Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip Resident of Baltimore City, MD or Little Rock, AR and surrounding area PED has flagged case as suspected abuse Another household member is enrolled in the study In Arkansas, less than 18 years without parent present at the PED | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 13.0-18.0, Health Risk Behaviors Health Care Services Quality of Care Eligible individuals will be 13-18 years old who have an appointment to see a provider at a participating clinic and will be able to read and comprehend English Individuals will be excluded from the study if they do not meet age requirements do not have an appointment at a participating clinic lack the means to complete follow-up interviews (i.e., has neither telephone not internet access) have a sibling who has/is being enrolled in the study and/or are not able to read or comprehend English | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Fasting Diet Biosensing Techniques Awake and alert Not on a regular diet No mild to moderate acute pancreatitis No obstructed bowel not amenable to feeding tube placement beyond the obstruction No massive GI hemorrhage No impending or established toxic megacolon No colonic perforation No severe dysmotility making enteral feeding not possible No high output intestinal fistula Able to access the gut for enteral feeding Not awake and alert On regular diet Mild to moderate acute pancreatitis Obstructed bowel not amenable to feeding tube placement beyond the obstruction Massive GI hemorrhage Impending or established toxic megacolon Bowel perforation Severe dysmotility making enteral feeding impossible High output intestinal fistula Unable to access the gut for enteral feeding | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 16.0-17.0, Teen Drivers Motor Vehicle Accident High school student (16 or 17 at enrollment) Holds an intermediate driver's license Lives in parent/guardian's home Drives to school Has their own smartphone (iPhone 4S or newer or Android 4.3 or newer) with data plan Parent/guardian is willing to assist with installation Admits to texting while driving at least once in the last month Already uses a smartphone app or hardware device to limit cellphone use while driving | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 0.0-999.0, Brain Injuries Skull Fractures Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture Died before admitted to hospital | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 12.0-19.0, Sport-related Concussion Brain Concussion Healthy Contact/collision sport athletes (for example, american football, soccer, rugby, lacrosse, ice hockey, field hockey, basketball, wrestling, boxing, martial arts, water polo) History of concussion (suspected or diagnosed) in the previous 6 months History of neck pain or injury in the previous 6 months History of migraine headaches History of personal or parental history of a diagnosed anxiety disorder | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-999.0, Acute Abdomen Acute Appendicitis Patient presented with the complaint of right lower abdominal pain Suspected acute appendicitis Flank pain Previous appendectomy Pregnancy Unstable vital signs Frank peritonitis US performed before EP's examination | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 2.0-17.0, Pain Long-bone Fractures children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department accompanied by at least one of their parents in the emergency department suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the inclusion) within the first 12 hours after the injury at least one signed parental informed consent affiliated to health insurance analgesic treatment within the 6 hours before contraindication to one of the study drug cognitive impairment multiple injuries resuscitation manœuvres open fracture non affiliated to social security parental refusal | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 18.0-35.0, G.I.T. Motility After General Versus Spinal Anaesthesia Patients set for planned cesarean section under general or spinal anesthesia age from 18 to 37 years Full term(37-41 weeks) Singleton pregnancy Hemoglobin level more than 11 gm/dl Contraindication to regional anesthesia i.e(patient refusal,coagulopathy,significant hypovolemia,systemic or local sepsis,increased intracranial pressure,severe stenotic valvular heart disease,pre existing neurologic conditions and local anesthetic or fentanyl allergy High risk pregnancies as pre eclampsia,eclampsia,any medical disorder(DM,cardiac and thyroid diseases) Previous intestinal surgery,previous C.S. and previous gynecological operations | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 1.0-3.0, Children With Mobility Disabilities motor delays (sd>1.5) resulting in motor impairments that prevented functional independent mobility, such as rolling, crawling, walking aged between 12 months to 36 months old able to tolerate sitting with support for 30 minutes able to reach the objects with either one or two hands consent of the parents to agree to the testing procedures and participate in the training program at the hospital children with severe sensory impairments such as blindness, deafness parents/caregivers are not able to make a time commitment for the training phase | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 15.0-999.0, Wound Infection Complication Scar patients with a clinical diagnosis of acute appendicitis children under 14 are not included | 0 |
A 32-year-old woman is admitted to the ER following a car accident. She has sustained multiple injuries including upper and lower extremity fractures. She is fully awake and alert, and she reports that she was not wearing a seat belt. Her blood pressure is 134/74 mm Hg, and her pulse is 87/min. Physical examination reveals a tender abdomen with guarding and rebound in all four quadrants. She has no bowel sounds. | eligible ages (years): 13.0-18.0, Alcohol Risk Behaviors Health Care Services Quality of Care Eligible individuals will be 13-18 years old who are able to read and comprehend English Participants who indicate alcohol use consistent with moderate to high risk on the Check Yourself App Individuals will be excluded from the study if They do not meet age requirements Do not have a study visit at a participating school-based health clinic Lack the means to complete follow-up interviews (i.e. have neither telephone or internet access) Are not able to read or comprehend English | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Glomerulonephritis, Membranoproliferative Lupus Nephritis Must give written informed consent prior to any testing under this protocol Must be 18 years or older, inclusive, at the time of informed consent Must have a renal biopsy showing active WHO Class III, IV, or mixed membranous and proliferative SLE GN, within the 5 years prior to the first dose of study drug Must have proteinuria of greater than or equal to 1.0 g/day at both the Day-27 and day-13 evaluations Must fulfill any one the following four at each of the two screening visits (i.e., Day-27 and Day-13) Anti-dsDNA antibody greater than 2x the upper limit of normal (ULN) C3 complement less than 80 mg/dL Hematuria greater than 5 rbc/hpf Urinary granular or red blood cell casts Must not have any medical disorder, which in the opinion of the investigator, should the subject from this study | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Cardiovascular Diseases Coronary Disease Thrombosis Heart Diseases Lupus Erythematosus, Systemic | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 1.0-55.0, Purpura, Schoenlein-Henoch Graft Versus Host Disease Anemia, Hemolytic, Autoimmune Rheumatoid Arthritis Churg-Strauss Syndrome Hypersensitivity Vasculitis Wegener's Granulomatosis Systemic Lupus Erythematosus Giant Cell Arteritis Pure Red Cell Aplasia Juvenile Rheumatoid Arthritis Polyarteritis Nodosa Autoimmune Thrombocytopenic Purpura Takayasu Arteritis Autoimmune thrombocytopenia purpura: platelet count less than 20,000/mm3 Adequate or increased marrow megakaryocytes Presence of detectable platelet associated immunoglobulins not due to alloreactive antibodies or posttransfusion purpura Prior response to immunosuppressive therapy Platelet count chronically less than 20,000/mm3 with petechial bleeding or less than 50,000/mm3 with other bleeding OR Any history of life threatening hemorrhage Refractory to conventional therapy for at least 21 days Splenectomy At least 1 additional immunosuppressive therapy applied after splenectomy OR Controlled on conventional therapy but at price of unacceptable toxicity: Serious steroid related toxicity Absolute neutrophil count less than 500/mm3 25% of time, pure red blood cell transfusion dependent or other toxicities (e.g., hemorrhagic cystitis) that are a consequence of chronic or cytotoxic therapy Unable to wean from chronic daily or intermittent cytotoxic therapy Autoimmune hemolytic anemia or pure red cell aplasia, AIHA: Hemolytic anemia Hemoglobin less than 10.0 g/dL without transfusion Hemolysis as evidenced by both: Sustained reticulocytosis (greater than 125,000/mm3) without evidence of active bleeding or increasing hemoglobin Laboratory evidence of hemolysis Positive direct antiglobulin test or equivalent immune adherence test No evidence for paroxysmal nocturnal hemoglobinuria Negative Ham's test and sucrose hemolysis. For PRCA: Anemia due to selective decrease in marrow erythroid precursors Hemoglobin less than 10.0 g/dL without transfusion Severe reticulocytopenia (less than 20,000/mm3 despite anemia) Severely decreased marrow erythroid precursors Positive marrow coculture with serum or cells or response to immunosuppression No evidence for PNH Negative Ham's test and sucrose hemolysis Severe disease: Chronic (i.e., greater than 1 year) Transfusion dependent or untransfused hemoglobin less than 8.0 g/dL Ferritin greater than 2,000 or evidence of organ dysfunction due to iron overload Refractory to conventional therapy after all 3 of the following: High dose steroids (at least 1 mg/kg) for at least 21 days Splenectomy (except cold reactive antibodies) 1 additional immunosuppressive therapy OR Controlled on conventional therapy but at price of unacceptable toxicity Rheumatoid arthritis: Morning stiffness for at least 6 weeks Arthritis of 3 or more joint areas Arthritis of hand joints Symmetric arthritis Rheumatoid nodules Serum rheumatoid factor Radiographic changes Active rheumatoid disease as evidenced by all of the following: Elevated Westergren erythrocyte sedimentation rate Minimum of 16 swollen or tender joints using the 28 joint count method Must be at high risk for developing deforming joint disease as defined by at least 2 of the following: High titer IgM-IgG rheumatoid factor Radiographic evidence of erosive arthritis developing within the first 24 months of clinical disease Functional class II or III Refractory to conventional therapy after 12 months of: Methotrexate used in combination with cyclosporine, hydroxychloroquine, or sulfasalazine OR Intramuscular gold therapy (total dose greater than 1.0 g and duration at least 6 months) OR Controlled on conventional therapy but at price of unacceptable toxicity Juvenile rheumatoid arthritis: Under 16 years of age at onset Arthritis in 1 or more joints as defined by swelling or effusion, or presence of 2 or more of the following: Limitation of range of motion Tenderness or pain on motion Increased heat Duration of disease 6 weeks or longer Onset type defined by type of disease in first 6 months: Polyarthritis (i.e., 5 or more inflamed joints) Oligoarthritis (i.e., less than 5 inflamed joints) Systemic (i.e., arthritis with characteristic fever) of other forms of juvenile arthritis Active disease evidenced by 1 of the following: Minimum of 2 swollen or tender joints using the 71 joint count method Endocardial or myocardial disease, or serositis Anemia or thrombocytosis of chronic disease High risk for developing deforming joint disease or evidence of potential life threatening involvement for at least 1 internal organ system Radiographic evidence of erosive arthritis developing within first 24 months of clinical disease Functional class II or III Endocardial, myocardial, pericardial, and/or pleural disease Hemoglobin less than 10.0 g/dL or platelet count greater than 600,000/mm3 Refractory to conventional therapy after 12 months of methotrexate used in combination with hydroxychloroquine, sulfasalazine, azathioprine, cyclosporine, or cyclophosphamide OR Controlled on conventional therapy but at price of unacceptable toxicity Systemic lupus erythematosus: Malar rash Discoid rash Photosensitivity Oral ulcers Arthritis Serositis Renal disorder Neurologic disorder Hematologic disorder Immunologic disorder Antinuclear antibody Must have at least 4 of 7 variables on the lupus activity scale measured Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Azathioprine Cyclophosphamide (greater than 500 mg/m2 monthly for 6 months) Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Vasculitis Definitive diagnosis of 1 of the following forms: Churg-Strauss syndrome Giant cell arteritis Henoch-Schonlein purpura Hypersensitivity vasculitis Polyarteritis nodosa Takayasu arteritis Wegener's granulomatosis Evidence of active disease defined as reversible manifestations of the underlying inflammatory process Must have 1 or more of the following: Elevated Westergren erythrocyte sedimentation rate Elevated C reactive protein Decrease serum complement levels Evidence of potential life threatening involvement of at least 1 internal organ system Endocardial and/or myocardial disease Central nervous system disease Pulmonary parenchymal disease Renal disease defined as WHO III, IV or V and a high activity and low chronicity index Immune mediated cytopenias Refractory to conventional therapy (i.e., failed or relapsed within 6 months) after attempts to control disease with at least 2 drugs, including prednisone and 1 of the following: Methotrexate Azathioprine Cyclophosphamide Cyclosporine OR Controlled on conventional therapy but at price of unacceptable toxicity Performance status: ECOG 0-1 ECOG 2 allowed provided symptoms directly related to autoimmune disease Hepatic: No history of severe, prior or ongoing chronic liver disease Bilirubin less than 2.0 mg/dL AST less than 2 times upper limit of normal (ULN) Alkaline phosphatase less than 2 times ULN Renal: Creatinine less than 2.5 mg/dL OR Creatinine no greater than 2 times normal baseline for age in pediatric patients Cardiovascular: No symptoms of cardiac disease No active ischemic heart disease Ejection fraction greater than 45% by MUGA No uncontrolled hypertension Pulmonary: FEV1/FVC at least 60% OR Resting PO2 at least 80 mm Hg DLCO greater than 50% predicted O2 saturations greater than 94% in children unable to perform PFTs Neurologic: No active or ongoing ischemic or degenerative CNS disease not attributable to underlying disease Other: Not pregnant No poorly controlled diabetes HIV negative | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 13.0-999.0, Lupus Erythematosus, Systemic A diagnosis of systemic lupus erythematosus | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-70.0, Lupus Erythematosus, Systemic People may be eligible for this study if they Are 18 to 70 years of age Agree to use a reliable method of birth control during treatment and for 6 months after treatment ends Have SLE (by the American College of Rheumatology criteria) Have had SLE for at least 6 months prior to screening Have active SLE disease at the screening visit Have organ disease (lung, stomach, intestinal, blood, kidney, and/or heart) Have failed standard therapy, including at least 1 immunosuppressive agent, or have experienced side effects from an immunosuppressive agent that required discontinuation of treatment Meet blood, liver, and kidney laboratory values set by the protocol Have not taken an immunosuppressive agent for 2 weeks prior to the first treatment People will not be eligible for this study if they Are pregnant or breast-feeding Have heart, lung, nervous system, kidney, liver, stomach, intestinal, or other diseases that may place the patient at risk if participating in the trial Have cranial neuropathy (a condition affecting the head region) Are on blood-thinning agents to prevent blood clotting Have a serious skin disease Have a certain class of heart disease Have had cancer, unless surgically cured basal cell carcinoma or cervical dysplasia Have a long term serious infectious disease such as tuberculosis or a fungal infection that is now active, or active within 2 years of the baseline visit Have had HIV infection or another immunosuppressive state (chemotherapy or radiation therapy) | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 10.0-21.0, Lupus Erythematosus, Systemic Meets American College of Rheumatology (ACR) revised diagnostic guidelines for SLE Weight of 25 kg (55 lbs) or more Outpatient Ability to complete self-report questionnaires in either English or Spanish Willingness to comply with recommended diet Acceptable methods of contraception Drug-induced lupus Liver disease (ALT or aspartate aminotransferase greater than 2 X normal value) Myositis (CK greater than 3 X normal value) Inability to obtain adequate-quality IMT images Current use of oral or parenteral tacrolimus or cyclosporine Dialysis or serum creatinine reater than 2.5 mg/dL Active nephrotic syndrome (urinary protein greater than 3 g/24 h and serum albumin less than 2.3 g/dl) Total cholesterol greater than 350 mg/dL Xanthoma Familial hypercholesterolemia | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Systemic Lupus Erythematosus Families in which one or more living members have been diagnosed with systemic lupus erythematosus | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Lupus Erythematosus, Systemic Primary Clinical diagnosis of SLE "Active" SLE disease On a stable SLE treatment regimen History of measurable autoantibodies Primary Received a non-FDA approved investigational agent within last 28 days Cyclosporin, intravenous immunoglobulin (IVIG) or plasmapheresis within last 90 days Active lupus nephritis requiring hemodialysis, cyclophosphamide (Cytoxan™), or high-dose prednisone (> 100 mg/day) within last 90 days Active central nervous system (CNS) lupus requiring therapeutic intervention within last 60 days History of renal transplant History of chronic infection that has been active within last 6 months, herpes zoster within last 90 days or any infection requiring hospitalization or intravenous medication within last 60 days History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 0.0-999.0, Neonatal Lupus Systemic Lupus Erythematosus Sjogren's Syndrome Congenital Heart Block Mother with antibodies to SSA/Ro, SSB/La, or ribonucleoproteins (RNP) OR Child of mother with such antibodies who has neonatal lupus (congenital heart block, transient skin rash, and/or hepatic or hematologic manifestations) OR Father of neonatal lupus-affected child OR Maternal grandparents of neonatal lupus-affected child OR Maternal aunts and uncles of neonatal lupus-affected OR Unaffected siblings of neonatal lupus-affected child | 0 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus participants must be diagnosed with SLE and be experiencing an active lupus flare in at least one of three organ systems: skin (discoid lesions), inflammation of the lining of the heart (pericarditis), or inflammation of the lining of the lung (pleuritis/pleurisy); or inflammation of more than 4 joints within 14 days of a screening visit (arthritis) Stable dose of prednisone (<30mg) for at least one month participants experiencing an active lupus flare in the kidney or central nervous systems Treatment with a stable dose of azathioprine, mycophenolate mofetil, hydroxychloroquine, chloroquine, or methotrexate for less than three months prior to the study participants with active viral or bacterial infections participants with any other autoimmune disease as a main diagnosis Prior treatment with rituximab | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Lupus Nephritis Lupus Erythematosus, Systemic Fulfill the revised American College of Rheumatology for SLE Have biopsy-proven membranous nephropathy secondary to SLE Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents) Age over 18 with informed consent Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study Patient with abnormal liver function tests Patient with hepatitis B surface antigen or who is hepatitis C antibody positive Patient who is diabetic Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion Patient is allergic or intolerant to macrolide antibiotics or tacrolimus | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Rheumatoid Arthritis Systemic Lupus Erythematosus SLE, RA, or healthy | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, Systemic Lupus Erythematosus Clinical diagnosis of SLE Self-reported cognitive impairment Age < 18 years History of non-compliance Pregnancy Liver or renal insufficiency/failure (calculated creatinine clearance < 50 cc/min) Severe SLE flare in the last 6 weeks (defined as > 12 points) Recent (within 4 weeks) change in any medication relevant to cognitive function, including prednisone, anti-depressants, medications for insomnia, narcotic medications, attention deficit disorder medications Current alcohol or illicit drug abuse Current use of Namenda, Aricept, Provigil | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Chronic Fatigue Syndrome Myalgic Encephalomyelitis A diagnosis of CFS, as defined by the Center for Disease Control (1988 CDC case definition) > 12 months (Appendix D) Age Range: > 18 years old, < 60 years old Males or non-pregnant, non-lactating females: Females must be of non-child bearing potential (either post-menopausal for two (2) years or surgically sterile including tubal ligation) or using an effective means of contraception (birth control pills, intrauterine device, diaphragm). Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test within the two (2) weeks prior to the first study medication infusion. Females of child bearing potential agree to use an effective means of contraception from four (4) weeks prior to the baseline pregnancy test until four (4) weeks after the last study medication infusion A reduced quality of life as determined by a documented KPS of 40 to 60 on three (3) occasions, each at least 14 days apart, during the twelve (12) weeks immediately preceding the start of study drug infusions. The KPS must be rounded in increments of ten (10) Ability to walk (minimum of 20 seconds) on the moving treadmill (grade = 0%; belt speed = 1 mph) on a minimum of two (2) occasions during the twelve (12) weeks immediately preceding study entry Laboratory documentation (baseline or historical following onset of CFS/ME) of a negative ANA or a negative anti-ds (double-stranded) DNA, a negative Rheumatoid Factor, and an erythrocyte sedimentation rate (ESR) Laboratory documentation that the patient is euthyroid (patients on thyroid replacement therapy must be on a stable dose during the eight (8) week washout period) based on a thyroid profile (T4, T3, TSH, T3 uptake and Free T4 index) performed during baseline Ability to provide written informed consent indicating awareness of the investigational nature of this study | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-65.0, Lupus Erythematosus, Cutaneous Lupus Erythematosus, Discoid Subjects may be included only if they fulfil the following on the pre-treatment days (between Day -14 and Day -2) and on Day 1 (before first application of study medication) Female and male patients aged 18-65 years (females of childbearing potential may be enrolled provided they are routinely using adequate contraception in the assessment of the investigator) Patients with histologically defined dLE or scLE The test sites (lupus erythematosus plaques) must be on the face only, and have a total sign score of 4 or more (sum of erythema, induration and scaling scores) and must be the same within a given patient (ie not differing in the sum for erythema, induration or scaling). Each of the 2 test sites must be at least 3 cm apart The patients must receive a baseline medication with chloroquine Patients must have been informed about the study procedures and medication and must have given their written Informed Consent Patients expected to be available for the duration of the study and able to comply with the study visits Any of the following will disqualify a patient from participating in this study Systemic therapy for lupus erythematosus within one month prior to first application of study medication in this study (steroids, retinoids, herbal medicines, etc) except chloroquine Patients with systemic lupus erythematosus or patients whose chronic discoid lupus erythematosus appears to be spontaneously flaring or improving based on the experience of the investigator Patients who are receiving oral medication, known to precipitate lupus lesions (e.g. procainamide, diuretics, piroxicam, beta blockers, griseofulvin, lithium and other psychotropic drugs) Topical therapy [i.e. corticosteroids, etc.] within 2 weeks prior to first application of study medication Patients with clinically significant medical conditions which could interfere with the conduct of the study. This includes Renal impairment (creatinine > 2.0 mg/dl) Hepatic impairment (liver function test values above notable abnormalities; g-GT, ALAT, ASAT: 2x the upper limit) Haematologic disorders (haemoglobin, platelet, erythrocyte and leukocyte counts above notable abnormalities) Neurologic disorders (significant impairment of sensory and motor function as judged by the investigator) | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Systemic Lupus Erythematosus Male or female subjects between the ages of 18 and 60 years, inclusive Meet at least 4 of 11 American College of Rheumatology (ACR) Revised Classification for SLE Have at least one of the following conditions defining severe steroid refractory disease a) Lupus nephritis Subjects must have severe disease, defined as meeting for BILAG renal category A, and be corticosteroid dependent while receiving at least 6 months of pulse CTX at doses of 500 to 1000 mg/m2 every 4 weeks or MMF at of 2 g/day or greater. If nephritis is to constitute the sole a renal biopsy performed within 11 months of the date of screening must show ISN/RPS 2003 classification of lupus nephritis Class III or IV disease. A renal biopsy must demonstrate the potential of a reversible (non-fibrotic) component. b) Visceral organ involvement other than nephritis Subjects must be without mesenteric vasculitis. The subject must be BILAG cardiovascular/respiratory category A, vasculitis category A, or neurologic category A, and be corticosteroid dependent while receiving at least 3 months of oral (2 to 3 mg/kg/day or greater) or IV CTX (500 mg/m2 or greater every 4 weeks). c) Cytopenias that are immune-mediated Subjects must be BILAG hematologic category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, MMF at 2 g/day or greater for more than 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or have had a splenectomy. d) Mucocutaneous disease Subjects must meet BILAG mucocutaneous category A and be corticosteroid dependent while receiving at least 1 of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months; methotrexate at 15 mg/week or greater for at least 3 months; CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, cyclosporine at 3 mg/kg/day or greater for at least 3 months, or MMF at doses 2 g/day or greater for at least 3 months. e) Arthritis/myositis Subjects must meet BILAG musculoskeletal category A and be corticosteroid dependent while receiving at least one of the following: azathioprine at 2 mg/kg/day or greater for at least 3 months, methotrexate at 15 mg/week or greater for at least 3 months, CTX at 500 mg/m2 or greater intravenously every 4 weeks or 2 mg/kg/day or greater orally for at least 3 months, MMF at 2 g/day or greater for at least 3 months, or cyclosporine at 3 mg/kg/day or greater for at least 3 months Have the ability and willingness to provide written informed consent. In case of lupus cerebritis, a person designated by the subject may give consent HIV positive status Any active systemic infection Hepatitis B surface antigen positive Hepatitis C PCR positive Use of immunosuppressive agents for other indications other than SLE Any comorbid illness that in the opinion of the investigator would jeopardize the ability of the subject to tolerate therapy For lupus nephritis: renal biopsy, performed within 11 months of the screening date, showing Class I, II, or V disease or Class III or IV disease in conjunction with total sclerosis of 50% or more of the glomeruli Ongoing cancer. Patients with localized basal cell or squamous skin cancer are not excluded Pregnancy, unwillingness to use acceptable means of birth control, or unwilling to accept or comprehend irreversible sterility as a side effect of therapy Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-999.0, SLE Rheumatoid Arthritis SLE, RA | 2 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 16.0-75.0, Lupus Nephritis Diagnosis of systemic lupus erythematosus (SLE) according to current American College of Rheumatology (ACR) criteria Diagnosis of International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003 Class III or IV lupus nephritis (LN), with either active or active/chronic disease Proteinuria 75 years of age Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia that is currently active and resulting from SLE Unstable subjects with thrombocytopenia experiencing or at high risk for developing clinically significant bleeding or organ dysfunction requiring therapies such as plasmapheresis or acute blood or platelet transfusions Lack of peripheral venous access Pregnancy or lactation History of severe allergic or anaphylactic reactions to monoclonal antibodies Significant or uncontrolled medical disease in any organ system not related to SLE or LN, which, in the investigator's opinion, would preclude subject participation Concomitant chronic conditions, excluding SLE (eg, asthma, Crohn's disease) that require oral or systemic corticosteroid use in the 52 weeks prior to screening History of renal transplant Known human immunodeficiency virus (HIV) infection Known active infection of any kind (but excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous anti-infectives within 4 weeks of randomization or oral anti-infectives within 2 weeks of randomization | 1 |
A 21-year-old female is evaluated for progressive arthralgias and malaise. On examination she is found to have alopecia, a rash mainly distributed on the bridge of her nose and her cheeks, a delicate non-palpable purpura on her calves, and swelling and tenderness of her wrists and ankles. Her lab shows normocytic anemia, thrombocytopenia, a 4/4 positive ANA and anti-dsDNA. Her urine is positive for protein and RBC casts. | eligible ages (years): 18.0-60.0, Systemic Lupus Erythematosus Fulfill ACR Classification for SLE >18 and < 60 years old English-speaking/reading Has a treating rheumatologist at the Hospital for Special Surgery Estimated premorbid verbal I.Q. >80 measured by the North American Adult Reading Test Functional difficulties due to cognitive dysfunction defined as positive endorsement of ≥6 items on the Cognitive Symptoms Inventory (CSI). The CSI is a 21-item, self-report questionnaire designed to assess ability to perform everyday activities in patients with rheumatic disease.47 No physical or mental disabilities that would preclude or confound the results of the neuropsychological testing, e.g., compromised use of hands, severe visual or hearing impairment Able to read normal newsprint and hear a normal speaking voice Normotensive at time of enrollment with or without medication No arrhythmia or left ventricular hypertrophy on ECG Global cognitive impairment as measured by a Modified Mini Mental Status<77 History of arrhythmia; known history of left ventricular hypertrophy, mitral valve prolapse with syndrome, or other significant cardiovascular disease with a reduced ejection fraction Renal insufficiency (creatinine clearance < 30 ml/min) including dialysis patients Known liver disease (e.g., active hepatitis) or any liver function test >2x upper limit of normal (transaminases or GGTP) Significant and serious SLE activity defined as active central nervous system disease, active nephritis, ulcerative skin disease. Other active SLE-associated conditions involving major organ systems may be excluded at the discretion of the investigator Pregnancy, nursing mother, or unwillingness to use barrier contraception Diagnosis of active psychosis, ADHD, ADD Current use of medications contraindicated with the use of modafinil-triazolam, Phenobarbital, cyclosporine A, theophylline, carbamazepine, diazepam, phenytoin, mephenytoin, rifampin, ketoconazole, itraconazole Illegal drug or alcohol abuse (defined as two affirmative responses to the CAGE questionnaire) Prior use of modafinil | 1 |
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