topic
stringlengths 245
1.29k
| doc
stringlengths 52
16.9k
| label
stringclasses 3
values |
|---|---|---|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Delirium years of age or greater In the Emergency Department for less than 12 hour at the time of enrollment Severe mental retardation or dementia Baseline communication barriers such as aphasia, deafness, blindness, or who are unable to speak English Refusal of consent Previous enrollment Comatose Out of the hospital before the assessments are completed
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-85.0, Elderly between the ages of 65-85 independent in activities of daily living able to walk without assistance for at least 10 minutes cognitively intact (Mini Mental State Exam ≥24) reported 2 or more falls within 6 months prior to the beginning of the study any neurological, orthopedic or any other impairment likely to impact gait severe visual impairments major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Traumatic Brain Injury Age 18 or older Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease History of Stroke History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type History of Brain Tumor Status post trauma due to asphyxiation Preexisting contraindications for Magnetic Resonance Imaging (MRI) Active Duty Military Status Police custody or prisoner status Pregnant women
|
2
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 75.0-999.0, Delirium Elderly patient (≥ 75 years) Patient with planned hip fracture surgery within 48 hours after the hip fracture Patient willing and able to complete the requirements of this study including the signature of the written informed consent Patient suffering from multiple fractures, pelvic fractures proximal, pathological fractures, femur fractures (i.e., fractures of the middle or distal femur) Disabling neuropsychiatric disorders (severe dementia, Alzheimer's disease, schizophrenia, depression) Brain trauma within 12 months prior to selection, history of stroke with residuals Patient suffering from delirium (CAM diagnosis) at selection Patient who cannot complete the pre-operative mental tests (CAM and/or MMSE) of this clinical trial Patient with Mini-Mental State Examination (MMSE) score < 24 at selection Patient known to susceptible to malignant hyperthermia Patient with elevated intra-cranial pressure Patient with a risk of high oxygen demand Patient with recent or ongoing myocardial infarction / damage
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Posttraumatic Stress Disorder Involved in or witnessed a car accident at least 6 months ago PTSD or distress or impairment in important areas of functioning following the car accident moderate or severe head injury current mental health treatment for the MVA-related problem severe chronic pre-injury mental health problems
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 75.0-999.0, Postoperative Delirium Male or female subject aged over 75 years Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement) Participation agreement Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Aging Decrease in Ambulation Age 65 years and older Must reside in Greve in Chianti or Bagno A Ripoli, Italy Subjects with modertative cognitive problems will be included as long as the consent can be read and signed by by a first-degree relative of the participant or, in absence of first-degree relative, another relative living with or close to the participant Children
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Healthy Japanese healthy elderly male and female ≥65 years old Have a BMI of ≥18 and ≤27 kg/m2 and weigh ≥ 45 kg Be able to understand and comply with the requirements of the study as judged by the investigator(s) History of any clinically significant medical or neurologic disease or disorder History of gastrointestinal surgery or unintentional rapid weight loss Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the study drug
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 75.0-999.0, Displaced Olecranon Fractures in Elderly Patients Age ≥75 years Minimal, moderate or severe fragmentation of the olecranon Within two weeks of olecranon fracture Patients unable to give informed consent Associated fractures to the coronoid, radial head and/or distal humerus Associated ligamentous injury, dislocation or subluxation Open fractures
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 50.0-999.0, Head Trauma Traumatic Brain Injury Chronic Subdural Hematoma Completion of informed consent by the patient or a legally appointed guardian Age ≥ 50 years Sustained mild head trauma with visit to the emergency department of the Hadassah-Hebrew University Medical Center within 24 hours after trauma Low-dose aspirin therapy (75-100 mg) at time of head trauma Admission non contrast head CT with no evidence of intracranial hemorrhage or skull fracture, as assessed by the neurosurgical resident on call and confirmed by an attending neuroradiologist Documented or suspected myocardial infarction within the last 12 mo Documented or suspected transient ischemic event or cerebrovascular accident within the last 12 months Coronary intervention within the last 6 mo Vascular stenting or bypass within the last 6 mo End-stage renal failure requiring dialysis Treatment with aspirin dose other than 75-100 mg Concomitant treatment by anti-coagulant or other anti-aggregant (e.g. warfarin, low molecular weight heparin, or clopidogrel)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-85.0, Contrast Media Induced Nephropathy Subjects of 18 years old or older CKD stage 3 according to GFR-MDRD equation Two consecutive stable plasma Creatinine levels during the last 2months Elective computed tomography (CT) with a nonionic low-osmolality radiographic contrast agent Acute/ chronic renal failure. Acute renal failure is defined as a change in serum creatinine concentration of at least 0.5 mg/dL, or 25% from creatinine measured before the study to that of the day of the procedure Intercurrent illness: e.g. fever… etc Recent exposure to radiographic contrast media in the last month before enrollment Allergy to contrast agents, PDE inhibitors or NAC Hypotension Pregnancy and lactation Multiple Myeloma Intravenous diuretics therapy Therapy with any of the nephroprotective drugs 2 weeks before enrollment such as N.A.C. PED5 inhibitor or Carnitine for any reason Severe Congestive Heart Failure, Acute Myocardial Infarction, moderate to severe liver failure (Child-Pugh class B or C)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 70.0-999.0, Delirium ≥ 70 years old Undergoing any lumbar spine surgery, posterior cervical spine surgery, or anterior cervical spine surgery > 2 levels MMSE < 15 Delirium at baseline Inability to speak and understand English Severe hearing impairment, resulting in inability to converse Planned use of intraoperative ketamine Planned use of intraoperative remifentanil, except for airway management pre-incision Arterial catheter not planned to be inserted
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Traumatic Brain Injury Trauma all patients with traumatic brain injury patients without traumatic brain injury
|
2
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Chronic Subdural Hematoma Newly diagnosed chronic subdural hematoma by CT scan or MRI, operated within the last 48 hours Age 18 years or older Written informed consent from the patient to participate in the study Moribund state of health prohibiting surgery Foreseeable difficulties in follow-up due to geographic reasons (e.g. patients living abroad) Recurrent hematoma if the first surgery was performed before study start CSH due to spontaneous spinal CSF fistula or meningeosis carcinomatosa Pregnancy Patient with Metastatic Disease
|
2
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 60.0-999.0, Elderly Delirium of Unknown (Axis III) Etiology Intensive Care (ICU) Myopathy Over 60 year old Delirium according to the CAM-ICU (Confusion Assessment Method for Intensive Care Unit) informed consent (legal representatives) unable to swallow pills previous allergy to donepezil Atrioventricular block of 2nd and 3nd degree
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Breast Cancer Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER) and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both HER2 is negative if a single test (or all tests) performed in a tumor specimen show IHC negative (0 or 1+) ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+ HER2 equivocal is not eligible Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Delirium adult patients admitted for cardiac surgery at department of cardiothoracic surgery, Rigshospitalet, denmark patients under age 18 patients that died within 24 hours after admission
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-50.0, Post Traumatic Stress Disorder Age 18-50 Experienced a traumatic event fitting criterion A1 (stressor), A2 (Reaction) and at least 1 out of the B criterion in the ASD in the DSM-IV-TR Brought to the ER within hours of the traumatic event Signed an informed consent Known psychiatric disorder or current psychiatric medication Complex injury or need for a complex medical treatment, such as operation, Packed RBC or admission extending 36 hours Disorientation, confusion, head injury including intra-cranial bleeding, LOC or a major neurological deficit Known disorder of the HPA axis or use of steroidal medications within the previous 3 years known neurological disease or previous brain surgery Major medical conditions or using medication known to influence the HPA or ANS Axis Baldness or hair shorter than 1cm Using color dyes Pregnancy
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-80.0, Subarachnoid Hemorrhage, Aneurysmal Intracerebral Hemorrhage (ICH) Traumatic Brain Injury Patients over 18 years onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h indication for implanting a tissue oxygen and intracranial pressure probe A signed informed consent by the patient or legal guardian Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode Open injuries in the area of the planned optodes Malignant primary disease under chemotherapy pregnancy bleeding disorder In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils) Patients with pacemakers or where no MRI compatibility is due to non removable metal parts contraindications for contrast media in CT (eg, iodine allergy) Untreated hyperthyroidism
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Stroke Patients with ischemic arteria cerebri media infarct and spontaneous intraparenchymal bleeding Patients with subarachnoidal haemorrhage, traumatic haemorrhage (epidural/subdural bleeding), cerebral venous sinus thrombosis, epilepsy, anti-epileptic treatment, transient ischemic attack, indication for urgent neurosurgical intervention
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Chronic Subdural Hematoma Patient at least 18 years of age presenting with a symptomatic chronic subdural hematoma Chronic subdural hematoma verified on cranial CT or MRI A subdural drainage cannot be placed due to intraoperative circumstances (e.g. brain unfolds) The surgeon decides based on intraoperative conditions to perform a craniotomy (e.g. acute hematoma indicating a craniotomy) Chronic subdural hematoma caused by another underlying illness (e.g. caused by over-drainage of a vp-shunt) no informed consent
|
1
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 50.0-99.0, Mental Competency Urinary Bladder, Overactive Cognitive Function Female 50 or older Diagnosis of OAB (ICS definition) English literacy Ability to swallow oral medication Cognitive ability to give consent Dementia/Depression/Delirium Current anticholinergic use (requires 2 week washout period) Current cholinesterase Urinary or gastric retention Severe decreased gastrointestinal motility Uncontrolled narrow-angle glaucoma Myasthenia gravis Diagnosis fo renal impairment (creatinine clearance <30 mL/min)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 2.0-999.0, Venous Thrombosis Pulmonary Embolism Atrial Fibrillation Acute Coronary Syndrome All male and female patients who have been prescribed for the first time either Rivaroxaban or standard of care from the date of market authorization of rivaroxaban to Dec 31, 2017 Patients who have any record of being dispensed their index drug in the year before index date (i.e. cohort entry), or who qualify for both cohorts on the same day
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 55.0-999.0, Mild Cognitive Impairment Patients who meet the Peterson diagnostic of MCI memory complaints (preferably confirmed by an informant) memory impairment according to age and education preserved general cognitive function intact activities of daily living, absence of dementia head trauma with post-traumatic loss of conscience for 30 minutes during lifespan loss of senses (blindness, deafness) photo-sensitive epilepsy unsuitability for Magnetic Resonance Imaging-examination due to metal foreign bodies or severe claustrophobia drug and/or alcohol abuse
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-75.0, Delirium Respiratory Failure Adult patients ≥ 18 yrs of age, < 76 yrs of age Admitted to MICU (3B and 3C) or SICU (8C, 8D, 11C) Surrogate present to provide informed consent when patient is not able RASS score of >-3, < +1 CAM positive Enteral access Recent MI (within past 2 weeks) High risk of dysrhythmias (i.e. bundle branch block, QT prolongation, class IV HF, implanted device) Unable to tolerate enteric medication History of stimulant induced mania/psychosis Pre-existing neurologic disease Patients transferred from outside hospital Pregnancy Alcohol withdrawal History of end stage liver disease (Childs-Pugh class B or worse) Prognosis considered hopeless (CMO)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Delirium Cognition Disorders Endotracheally intubated Expected time on ventilator > 24 hours Age ≥ 18 years Informed consent Severe head trauma where therapeutic coma is indicated Therapeutic hypothermia where therapeutic coma is indicated Status epilepticus where therapeutic coma is indicated Patient has participated in the study before Patient is transferred from another ICU with length of stay > 48 hours Patient is comatose at admission PaO2/FiO2 ≤ 9, if sedation is necessary for oxygenation Patient does not speak Danish, swedish or norwegian at a reasonable level
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 16.0-85.0, Cough Patients will be required to demonstrate significant cough symptoms by a score greater than 20/70 on the Hull Airways Reflux Questionnaire All patients must be current non-smokers Patients must be on stable medication for at least one month Patients must be able to attend the trials unit on at least 3 occasions Patients must have normal lung function patients must be able to give informed consent Subjects who are pregnant, or have pacemakers in situ are excluded from this study Those with a serious comorbid conditions such as cancer, severe COPD, or heart failure will be excluded Those who are non-English speakers and special groups (i.e. mentally ill, children under 16 years of age, and those suffering from dementia) will be excluded No test will be performed on any subject during an acute worsening of asthma or upper airway infection. If the subject has had an upper airway infection in the last three weeks they will be offered another appointment If the subject has taken any over the counter (OTC) cough mixture within the last twelve hours: If the subject is willing to come back another time for challenge testing, another appointment should be made If the subject has had any food or drink products containing caffeine or menthol within the last hour. If the subject is unwilling to wait for 1 hour before starting the test, the subject should return another time. If the subject is unwilling to return another time, testing should proceed and the medication used recorded If the participant is currently involved in research, or within 3 months of participation in any type of research, they will be excluded from this study
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Mild Cognitive Impairment Nursing home residents Surgery on lower limbs Traumatic damage on lower limbs Severe cognitive impairment in order not to complete the assessment
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Delirium Bone Fractures Multiple Trauma Patients with any medical condition with an age of 65 years and older Impossibility to give an informed consent; refusal
|
2
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 21.0-999.0, Alzheimer's Disease Cognitively Normal Subjects Males or females ≥ 21 and ≤ 45 years of age Mini-mental state examination (MMSE) ≥ 29 Clinically Diagnosed AD Subject Males or females ≥ 50 years of age Meet clinical for dementia due to probable AD MMSE ≥ 16 and ≤ 26 Possible AD Subject Males or females ≥ 50 years of age Meet clinical for dementia due to possible AD Have had or currently have a diagnosis of neurodegenerative disorders other than AD Have a current serious or unstable illness that could interfere with completion of the study Subject has a known brain lesion, pathology or traumatic brain injury Have received or participated in a trial with investigational medications in the past 30 days Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study imaging session Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 60.0-999.0, Postoperative Delirium Age >/ 60 years American Society of Anesthesiologists (ASA) physical status 1-3 Undergoing scheduled surgery Giving an informed consent Impaired visual and auditory disturbance Cannot communicate with Thai language Undergoing neurosurgery
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-55.0, Oxidative Damage Healthy, non-pregnant subjects between 18 and 55 years of age. Apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association http://circ.ahajournals.org/content/97/22/2283/T6.expansion.html Subjects have to achieve a classification of "local class" based on age-graded time USA Track & Field. The age-graded time is the finish time adjusted to that of an open division participant using a factor for age and gender. Thus, the times for women and older participants are adjusted downward, while the times for most open division participants (such as 25-year-old men) remain the same. For example, a 55 year old woman has to run 29 minutes 45 seconds or better to be in the study http://www.usatf.org/statistics/calculators/agegrading/ For a man the same age, the equivalent time would be 25 minutes 2 seconds. This is approximately 60% of the speed of the current world record time for that age Subjects who will abstain from taking any nutritional supplements for the duration of the study, including vitamins and mineral supplements (Exception, ferrous sulfate, elemental iron, Vitamin D, Calcium). Subjects will also abstain from taking any over the counter products (herbals, melatonin, St. John's Wort, etc…) for the duration of the study The will be the following Under 18 and over 55 years of age; those who are not apparently healthy is classified as A-1, A-2, or A-3 according to the American Heart Association Subjects who are not able to run 5-km in the time required for their age and gender Subjects that will continue to take nutritional supplements, including over the counter products, for the duration of the study, including vitamins and mineral supplements (exception: Ferrous sulfate, Elemental iron, Vitamin D, Calcium) Subjects that are taking prescription medications with the exception of birth control Known allergy or sensitivity to milk thistle, Bacopa monnieri, Ashwagandha, turmeric (or ginger), tea, its parts, caffeine, tannins, or members of the Theaceae family
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 25.0-95.0, Stroke Apraxias Mild-moderate stroke after two month of the cerebrovascular attack Upper limb apraxia lasting at least 2 months Less than 9 points in validated Apraxia Screen of TULIA (AST) following Vanbellingen et al., 2010 Voluntary participation The neurologist, the occupational therapist and the patient judge the intervention to be necessary History of apraxia before current stroke Stroke had occurred less than two months or more than twenty four month ago Cognitive impairment (< 23 in normal school population and < 20 points with a low education or illiteracy, in Spanish validation of Mini-Mental State Examination (MMSE)) Severe aphasia Previous brain tumour History of other previous neurologic disorders Mother tongue different to Spanish Drugs addiction Intellectual or learning disorders Brain damage for traumatism or neurodegenerative process
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Post Operative Delirium older patient (≥65 years) patient with hip fracture and planned hip fracture surgery patient willing to complete this study patient with multiple trauma or multiple fractures, pathological fractures, pelvic fractures, femur fractures contraindication (serious illness or medical conditions) for general anesthesia contraindication (infection at the site of needle insertion, coagulopathy, international normalized ratio >1.4, platelet count <80×109 litre-1, allergy to local anaesthetics and so on) for regional anesthesia patient who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial patient known to susceptible to malignant hyperthermia known allergy or hypersensitivity to any drugs administered during this clinical trial previous participation in this clinical trial participation in another clinical trial within 4 weeks prior to selection
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Postoperative Delirium Elderly (> 65 years) frail patients undergoing non cardiac surgery under anaesthesia lasting for >60 minutes Patient willing and able to complete the requirements of this study disabling neuropsychiatric or neurological disorders(including severe dementia, Alzheimer's disease, schizophrenia, severe depression) patients suffering from delirium at selection patients who cannot complete the preoperative mental tests (CAM and/or Mini-Mental State Examination (MMSE)) of this clinical trial
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-55.0, Post-traumatic Stress Disorder (PTSD) Trauma for patients with PTSD age 18-55 years old currently diagnosed with PTSD and symptomatic with a Clinician-Administered PTSD Scale (CAPS) score > 50 for patients with PTSD any primary Axis I disorder other than PTSD (e.g. psychosis) medical or neurological illnesses likely to affect physiology or anatomy, i.e. uncontrolled hypertension, cardiovascular disorders a history of drug (including benzodiazepines (BZD)) dependence (Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria) within 1 year of the study and lasting longer than 2 years, except for alcohol dependence current pregnancy (as documented by pregnancy testing at screening or on the day of PET imaging study) current breast feeding use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day, or cannot abstain from smoking during the prescribed tests acute suicidal ideation or behavior, as defined by suicidal ideation and behavior during the 3-month period prior to enrollment in the study and while being enrolled in the study general MRI
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 40.0-85.0, Traumatic Brain Injury Chronic Traumatic Encephalopathy Mild Cognitive Impairment males between 40 to 85 years of age individuals who participated in contact sports (e.g., active and retired NFL players, NHL players, boxers, NCAA athletes) and other individuals (including but not limited to veterans, breachers, or law enforcement officials with multiple blast exposures) who all have a history of one or more concussions and have a memory or cognitive complaint individuals with Mild Cognitive Impairment (MCI) and no history of concussion or TBI healthy controls with no history of head injury and no current cognitive or memory problems all participants require a study partner, who is well acquainted with the participant, to answer questions either in person or over the telephone about the individuals' activities of daily living, and to corroborate cognitive problems and past history of brain injury any significant neurological disease, such as Alzheimer's disease, Parkinson's disease, vascular dementia, Huntington's disease, Pick's disease, Lewy Body Dementia, frontotemporal dementia, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, or multiple sclerosis any significant systemic illness or unstable medical condition, including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer a history of schizophrenia or psychosis, alcohol or substance abuse or dependence within the past 6 months clinically significant impairment of liver or renal function significant cerebrovascular disease impairment of visual or auditory acuity sufficient to interfere with completion of study procedures education level < 10 years any subjects with a history of risk factors for Torsades de Pointes, or subjects taking drugs known to prolong the QT interval subjects who have had 2 or more PET scans within the past year, or other significant exposure to radiation (i.e., radiation therapy)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 60.0-999.0, Delirium C.Surgical Procedure; Cardiac Postoperative Complications Patients of 60 years or older who are planning to receive cardiac surgery (CABG and/or valve replacement surgery) Patients will be excluded if they meet any of the following Refuse to participate Preoperative history of schizophrenia, epilepsia, Parkinson syndrome, or severe dementia Inability to communicate in the preoperative period because of severe visual/auditory dysfunction or language barrier History of brain injury or neurosurgery Preoperative sick sinus syndrome, severe bradycardia (HR < 50 bpm), second-degree or above atrioventricular block without pacemaker Severe hepatic dysfunction (Child-Pugh class C) Severe renal dysfunction (requirement of renal replacement therapy) Other conditions that are considered unsuitable for participation
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 30.0-80.0, Delirium Postoperative Complications Male or female, between 30 and 80 years of age ASA I , II or III Capable and willing to consent Participants literate in English language ASA IV or V Patients with severe visual or auditory disorder Illiteracy Presence of a clinically diagnosed major psychiatric condition such as bipolar disorder, uncontrolled major depression, schizophrenia Dementia of Alzheimer's type Parkinson disease Multiple Sclerosis (MS) Vascular dementia
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 75.0-999.0, Abdominal Pain Elderly patients admitted to the emergency department (aged 75 year old and older) acute abdominal pain informed consent traumatic pain symptom duration of more than a week unability for the patient to give informed consent
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-80.0, Delirium presence of delirium presence of Alzheimer's disease any mental disorder presence of cancer
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-80.0, Delirium presence of delirium presence of Alzheimer's disease any mental disorder presence of cancer
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 60.0-999.0, Delirium years and older Frail Undergoing elective surgery Expected to remain admitted for at least 2 postoperative days No communication possible due to a language barrier or deafness Admission for neurological surgery Participation in this study during a previous hospital admission Practical or logistical reasons hampering the use of the delirium monitor, such as technical failure of the monitor Isolation because of known carrier ship of a resistant bacterium
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Delirium Confusion Intensive care unit patient years of age or older confirmed within 24 hours of admission Positive Confusion Assessment Method score Anticipated intensive care unit stay less than one day Less than 18 years of age Inability to wear a motion sensor watch (ActivPal)
|
1
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
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
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
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 their own house or 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
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Stroke Atrial Fibrillation (AF) Intracerebral Haemorrhage (ICH) Study I: (AF) Adult (≥18y; no upper limit) patients with a clinical diagnosis of non-valvular AF (verified by ECG) with intention to treat with best practice oral anticoagulants (e.g. warfarin) Previous ischaemic stroke or TIA diagnosed by treating clinician All patients must be able to have GRE MRI before (or within 1 week) of starting best practice oral anticoagulant Any MRI contraindications Previous use of oral anticoagulation Definite contra-indication to oral anticoagulation Serious head injury (resulting to loss of consciousness) Study II: (ICH) • Adult (>18y) patients treated at participating centres with confirmed ICH (confirmed on CT or MRI scans) with or without a history of anticoagulant use at the time of the ICH Known underlying structural cause for ICH (e.g arteriovenous malformation, tumour, cavernoma, intracranial aneurysm, haemorrhagic transformation of an infarct) Major head trauma (causing loss of consciousness and though to be sufficient to have caused the ICH) in previous 24 hours
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Delirium ICU patients aged ≥18 years Surgical, medical, neurology/neurosurgical, or trauma patients Delirious at ICU admission Expected ICU stay shorter than 6 hours Unable to reliably assess ICU delirium due to sustained coma during entire ICU stay unable to understand the language spoken severely mentally disabled serious receptive aphasia serious auditory or visual disorders
|
1
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
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
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 75.0-999.0, Acute Dyspnea Admission to the Emergency Department Age ≥ 75 years AND of acute dyspnoea Breathe rate ≥ 25 cycles/minute or PaO2 ≤ 70 mmHg or SpO2 ≤ 92% in room air or PacO2 ≥ 45 mmHg and pH ≤ 7.35 AND Electrocardiogram in sinus rhythm at admission
|
1
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Delirium Patients with an age equal or older than 65 years Hospitalized at the Acute Geriatric Unit of the "Complejo Hospitalario Universitario of Albacete" Valid signed informed consent by the patient or legal representative Agonic situation Non-Spanish speaking Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7) Patients sharing the same room with a previously included participant
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Delirium from designated nursing units
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Trauma Injury Severe Trauma Population will be All adults (age ≥18) Blunt and/or penetrating trauma patients with hemorrhagic shock, defined by either a systolic BP (SBP) <90 mm Hg or base deficit (BD) <-6 meq Ability to obtain Informed Consent prior to OR repair of injury will be Patients not expected to survive greater than 48 hours Prisoners Pregnancy Transfer from another hospital Patients receiving chronic corticosteroids or immunosuppression therapies Previous bone marrow transplantation Patients with End Stage Renal Disease Patients with any pre-existing hematological disease Elective Hip Repair Population
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Fracture Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring) Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014 Ambulatory before surgery Informed consent for study participation by the patient or legal representatives Refusal of consent by the patient or legal representatives to participate in the study Fractures within the last 3 months before follow-up Suspicion of a pathological fracture in the context of known or unknown malignancy Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 18.0-999.0, Delirium Intensive Care Unit Syndrome Patients >18 years of age admitted to the ICU at Køge Hospital in the study period Richmond Agitation Sedation Score (RASS): -4 or -5 during the whole study period No CAM-ICU scores during the ICU stay Unable to communicate in Danish (aphasic, deaf, non-Danish speaking, severe brain damage) Severe dementia documented in electronic patient charts (OPUS) Patients not receiving active treatment (moribund patients)
|
0
|
An 85-year-old man is brought to the ER because of gradual decrease in his level of consciousness. In the last 3 days he stopped walking and eating by himself. He has had no fever, cough, rash or diarrhea. His daughter recalls that he had been involved in a car accident 3 weeks prior to his admission and had a normal head CT at that time.
|
eligible ages (years): 65.0-999.0, Postoperative Complications Written informed consent ≥ 65 years of age Scheduled to undergo elective cardiac surgery (coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery) with the use of CPB Both genders Planned deep hypothermic arrest Acute / emergency procedures Surgery without extracorporeal circulation (ECC) Patients with a history of pseudocholinesterase deficiency Employees of the respective study centres Illiteracy Severe communication difficulties and severe vision or hearing problems Patients legally unable to give written informed consent non-fluency in German language Severe psychiatric or neuropsychiatric disorders
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 0.0-999.0, Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers Greater than 20% sustained rise in beta HCG titer over two consecutive weeks Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum) Histologically proven nonmetastatic choriocarcinoma Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm) WHO score 0-6 (not including blood group or CT lung) No histologically confirmed placental site pseudotumor Must have undergone at least 1 uterine curettage Previously untreated disease
|
1
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 33.0-50.0, Leiomyoma Women receiving insulin or thyroid hormone replacement may participate if well-controlled; use of vitamins and calcium under RDA is allowed Female gender-to evaluate effects in the target population for clinical trials In good health. Chronic medication use is acceptable except for glucocorticoid use. Other chronic medication use may be acceptable at the discretion of the research team. Interval use of over-the counter drugs is acceptable but must be recorded Menstrual cycles of 24 days Hemoglobin greater than 10 g/dL Willing and able to comply with study requirements Age 33 to 50 Using mechanical (condoms, diaphragms), sterilization or abstinence methods of contraception for the duration of the study Negative urine pregnancy test Significant abnormalities in the history, physical or laboratory examination Pregnancy Lactation Use of oral, injectable or inhaled glucocorticoids or megesterol within the last year Unexplained vaginal bleeding History of malignancy within the past 5 years Use of estrogen or progesterone-containing compounds, such as oral contraceptives and hormone replacement therapy, within 8 weeks of study entry, including transdermal, injectable, vaginal and oral preparations Use of agents known to induct hepatic P450 enzymes; use of imidazoles Current use of GnRH analogs or other compounds that affect menstrual cyclicity FSH greater than 20 IU/mL
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 18.0-999.0, Uterine Fibroids Leiomyoma Premenopausal women, at least 18 years of age Diagnosis of uterine fibroid(s), confirmed by ultrasound History of menstrual cycles between 17 and 42 days Otherwise in good health Scheduled for a hysterectomy at the end of the treatment period Negative pregnancy test Agrees to double barrier method of contraception Pap test with no evidence of malignancy or pre-malignant changes Endometrial biopsy with no significant histological disorder Less than 3 months after having a baby or breast-feeding Any abnormal lab or procedure result the study-doctor considers important Severe reaction(s) to or are currently using any hormone therapy History of cancer or alcohol or drug abuse Diagnosis of Polycystic Ovary Syndrome History of prolactinoma Current use of Intrauterine Device Significant gynecological disorder Uterine size > 32 weeks gestation Current diagnosis of endometriosis
|
1
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 18.0-999.0, Fibroid Uterus Leiomyoma Menorrhagia Metrorrhagia Uterine Fibroids Women that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment Otherwise good health Premenopausal based on Estrogen and Follicle Stimulating Hormone levels Agrees to double-barrier method of contraception Adequate endometrial biopsy with no significant histological disorder Any abnormal lab or procedure result(s) the study-doctor considers important History of a blood-clotting disorder Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away Significant gynecological disorder, such as endometrial polyp
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 20.0-50.0, Trophoblastic Neoplasms Hydatidiform Mole Choriocarcinoma Gestational Trophoblastic Neoplasms Unwilling to participate in the study
|
2
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 20.0-45.0, Uterine Fibroids Pregnancy Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test Women undergoing fertility treatment or plan to have sperm donation Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site Able and willing to give consent and able to attend all study visits Able to communicate sensations during the MRgFUS procedure Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone) Tumor(s) are clearly visible on non-contrast MRI Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH Patient is pregnant as confirmed by pregnancy test at time of screening Uterine size >20 weeks as evaluated by US or MR Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable Patients with adenomyosis Patient is on dialysis Hematocrit is < 25 Patient has hemolytic anemia Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence of cardiac pacemaker Patient has an ASA score of >2
|
1
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 0.0-999.0, Trophoblastic Neoplasms Uterine Neoplasms Hydatidiform Mole Choriocarcinoma Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT) WHO score 2-6 (re-evaluated at the time of relapse Histologically confirmed complete or partial moles on initial evacuation Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/ folinic acid) Patients with more than 8 metastatic lesions identified Patients with metastases to liver, spleen, brain, kidney or GI tract
|
2
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 18.0-999.0, Melanoma Male and female subjects above age 18 of any ethnicity will be enrolled in this study Subjects will be excluded from the study if they have significant skin disease which would not allow manipulation of their photographs consistent with the rest of the subjects Since the study instructions are in English, Non-English speakers will be excluded Those with co-morbidity sufficiently severe to prevent them from being able to perform a SSE will be excluded In addition, those with cognitive impairment who are unable to give informed consent, or to understand the study instructions given to them, will be excluded
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 18.0-999.0, Recurrent Herpes Labialis Patients aged 18 years or older A history typical for recurrent herpes labialis. The subject must have experienced three or more episodes of cold sores in the last 12 months, and have a history of prodromal symptoms, as defined by the patient, preceding at least 50% of these cold sores, and must also have a history of vesicular lesions in at least 50% of the recurrent episodes of cold sores General good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient's account of his/her medical history Women of child bearing potential had to use an accepted method of birth control (surgical sterilization; intra-uterine contraceptive device; oral contraceptives; hormone delivery systems such as Norplant® or Depo-Provera injections; a diaphragm in combination with contraceptive cream, jelly, or foam; or a condom in combination with contraceptive cream, jelly or foam). Patients unable or unwilling to use one of the methods of birth control listed above for the duration of the study could not enter the study For women of child-bearing potential, a negative pregnancy test (urine) at screening was required Signature on the informed consent document Previous herpes vaccination Patients using topical immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) on or near the face or systemic immunosuppressive agents (including steroids, tacrolimus and pimecrolimus) within 30 days of screening Patients known to be immunosuppressed due to underlying disease (e.g. HIV infection) or concomitant treatment (e.g. cancer chemotherapy) Recent history of alcohol or drug abuse, which in the opinion of the investigator, could interfere with that study patient's compliance with study requirements Significant skin disease such as atopic dermatitis or eczema that would interfere with the assessment of lesions Allergy or hypersensitivity to formulations containing acyclovir, penciclovir, famciclovir, and/or other nucleoside analogues Women who were lactating or breast feeding Had already been randomized once into the study Patients who had received an investigational drug in the past four weeks
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 30.0-999.0, Uterine Fibroids Menorrhagia and/or bulk symptoms associated with uterine fibroids Malignancy Current or planned pregnancy Small submucous fibroids suitable for hysteroscopic resection Postmenopausal women Suspected or known adenomyosis Uterus size exceeding the umbilical level Contraindications against laparoscopic surgery
|
2
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 5.0-999.0, Melanocytic Nevi Acquired Melanocytic Nevi Primary Cutaneous Melanoma Infants/Children Must be less than or equal to 5 years Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp Must have outside referring physician Adults Must be greater than 18 years Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension Can have prior history of cutaneous or ocular malignant melanoma Must have outside primary physician The patient does not meet the criteria Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome) Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome) Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator Patient is unwilling to consider elective biopsy of a melanocytic nevus
|
0
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 18.0-999.0, Uterine Leiomyomas Women included in the study must be at least 18 years if age, premenopausal, speak English, and have one or more uterine leiomyomas at least 2 cm in diameter and the utuerus must be enlarged to the size typical during the 8th week of pregnancy. Note that while the selcetion criteia are set to recruit women in which surgical intervention is a likely outcome, surgery is not a requirement for study inclusion Women will be excluded if they are pregnant because of potential safety concerns associated with imaging and image contrast enhancements. If women become pregnant during the study, they wil have the option to stay in the study, but will have pelvic ultrasound scans in place of MRI scans Women who are taking or likely to start taking GnRH therapy will be excluded because this therapy, which is used as a treatment method for leiomyomas, sometmes induces their regression Women who are greater than 52 inches in circumference or greater than 350 pounds will be excluded because they will be too large to fit in the imaging equipment Women that have an intra-uterine device (IUD) will be excluded because these metal devices create 'shadowing' in MR images, making accurate measurement and interpretation of leiomyomas in the MRIs difficult Women are not excluded if they had a prior myomectomy, or if they are taking oral contraceptives The of only women of premenopausal age (greater than 18 years old) in this study is dictated by the nature of the condition
|
1
|
A 36-year-old woman presents to the emergency department with 12 weeks of amenorrhea, vaginal spotting that has increased since yesterday, lower abdominal tenderness, nausea and vomiting. The physical exam reveals overall tender abdomen, 18-week sized uterus, and cervical dilation of 2 cm. The complete blood count and biochemical profile are normal. Point of care pregnancy test with cut-off sensitivity of 25 mIU/ml Beta-HCG is negative. The ultrasound reports enlarged uterus (12 cm x 9 cm x 7 cms) with multiple cystic areas in the interior. The differential diagnosis includes vesicular mole vs fibroid degeneration.
|
eligible ages (years): 30.0-50.0, Leiomyoma Leiomyomatosis Uterine Neoplasms Patient chooses to participate and has signed informed consent Age between 30 and 50 years old Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain Patient has fibroids confirmed by MRI Patient has normal kidney function Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility Patients with a history of gynecologic malignancy Patients with known endometrial hyperplasia Patients with adenomyosis Patients with pelvic inflammatory disease Patients with Uteri < 250 ml (cm) calculated volume or > 24 weeks Patients with pedunculated subserosal fibroids with a narrow attachment (<50% diameter of the fibroid) to the uterus Patients with pelvic pain as dominant syndrome Known allergy to contrast media that cannot be adequately pre-medicated Patients not suitable for arterial access
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 0.0-999.0, Healthy Movement Disorder Any volunteer of any age from birth to old age who is deemed medically fit to participate and is willing to provide their informed consent will be included in the study
|
2
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 0.0-999.0, Laryngeal Disease Spastic Dysphonia Voice Disorder Symptoms present during speech and not apparent at rest Symptoms less evident during whisper, singing or falsetto Symptoms become worse with prolonged speaking, practice or anxiety Reflexive and emotional aspects of voice function are unaffected, such as coughing, laughter or crying Any patient with a history of airway obstruction will be excluded from the study Structural abnormalities affecting the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, or inflammation (laryngitis) Reduction in vocal fold movement range during non-speech tasks such as whistling which would suggest either paralysis or paresis, joint abnormality or neoplasm No smokers or tobacco users will be included in the study Subjects with history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from the study. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, currently under treatment for a major depression, or a history of schizophrenia or a bipolar disorder. However, a history of a previous episode of a minor reactive depression would not a person from participation
|
1
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 0.0-999.0, Essential Tremor Patients with essential tremor affecting the upper limbs who are 21 years of age or older Patients who are not taking medications for essential tremor or any other medical condition for at least 2 weeks Patients who have not consumed alcohol or cold medications containing alcohol for at least 24 hours prior to the day of the study Women must not be pregnant or lactating. Women of childbearing age must use birth control while participating in this study Patients must not have any neurological disease other than tremor (e.g., Parkinson's disease) Patients must not have evidence of thyroid, liver, kidney or chronic lung disease
|
1
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 2.0-6.0, Cerebral Palsy Motor Deficits Clinical diagnosis of hemiparetic cerebral palsy consistent with in Swaiman and Russman (1999) and Badawi et al. (1998) Recommended for participation in pediatric rehabilitation and/or early intervention Lives within 50 miles of the Civitan Center at University of Alabama at Birmingham or the family is willing to temporarily relocate to the Birmingham area for treatment Profound bilateral hearing loss with the use of hearing aids Severe visual impairment Serious seizure disorder or uncontrolled seizures Genetic and syndromic conditions historically excluded for CP registries Familial Spastic Paraplegia Ataxic Cerebral Palsy Diagnosis of Pervasive Developmental Disability or autism Serious or recurring medical complications Scheduled for surgery within 12 months of study entry
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 21.0-999.0, Essential Tremor patients with a clinical diagnosis of essential tremor will participate in the study. Selection criterion is essential tremor with a history of ethanol responsiveness. Informed consent will be obtained by any of the co-investigators Patients must be off any medications used to treat essential tremor such as mysoline or propranolol for at least 2 weeks. Patients must withhold ethanol and caffeine 24 hours prior to starting the treatment periods through the end of treatment periods, including alcohol or caffeine containing over the counter medications. Ethanol and caffeine consumption is allowed in the washout period Patients with abnormalities on neurologic exam other than tremor Patients with a history of chronic alcohol dependence Patients with chronic medical conditions such as renal failure, hepatic failure and chronic lung disease Patients on other medications that cannot be temporarily discontinued for the length of the study Patients, who, for moral or religious reasons, do not wish to take a potentially intoxicating drug Patients with abnormalities on their baseline screening laboratory tests Women who are pregnant or lactating Patients under the age of 21 Asians and Pacific Islanders
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 21.0-999.0, Essential Tremor Patients with alcohol-responsive Essential Tremor Limb involvement should be a prominent feature of the Essential tremor Patients must be willing and able to safely stop and remain off any medications used to treat essential tremor for at least 4 half-lives Patients must be willing to abstain from ethanol and caffeine intake for at least 48 hours prior to starting the study hospitalization until study termination Patients must be willing and able to fast for periods of up to 12 hours during the study Patients with abnormalities other than tremor on neurological exam Patients with active or past alcohol abuse or dependence Patients with acute or chronic severe medical conditions such as renal failure, hepatic failure or lung disease Patients taking primidone Patients on other acute or chronic medications that influence hepatic metabolism or central nervous system (CNS) function and cannot be temporarily discontinued for the length of the study Patients who do not wish to take a potentially intoxicating drug Patients with abnormalities on their baseline screening laboratory tests Women who are pregnant or lactating Patients younger than age 21 The presence of cognitive impairment preventing informed consent or cooperation during the study
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-85.0, Stroke Cerebrovascular Accident Subjects will be included in the study on the basis of the following They must be at least six months post-stroke years of age or older with a clinical diagnosis of hemiparesis (as verified by medical record and a medical expert) They have voluntary control with a low to medium range of motion function (UE-FT<5) and a muscle tone They are functionally stable (no significant changes in motor function over a week) and are able to tolerate being seated upright for 90 minutes They report no excessive pain the impaired arm If left neglect or spasticity is detected in the impaired arm, these levels must not interfere with the ability to cognitively complete the tasks or turn a wheel They must not be participating in any experimental rehabilitation or drug therapies If subjects are receiving chemical injections for spasticity, they must be at least 3-months away from their last treatment They must have driven prior to stroke Subjects will be excluded from the study if they voluntarily decide to withdraw from the study or if they do not meet the above criteria Once informed consent is given twenty-four of these subjects will be randomized into two training groups (fun driving: fun and functional driving activities and rote tracking (12 subjects): rote and functional tracking activities). Two subjects will be randomized the case study group. The groups will be matched in initial motor function Subjects will be excluded if they voluntarily decide to withdraw from the study or if they do not meet the above criteria
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-999.0, Post-stroke Upper Limb Spasticity Main Female or male patients ≥ 18 years ≥ 6 months since the last stroke, diagnosed by an appropriate health care professional (e.g., neurologist) Focal spasticity with ≥ 2 points on the Ashworth Scale in the wrist flexors with clinical pattern Flexed Wrist Focal spasticity with ≥ 2 points on the Ashworth Scale in the fingers flexors with clinical pattern Clenched Fist For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for Flexed Wrist and Clenched Fist For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 50 Units BOTOX® or 200 Units Dysport® or 2000 Units Neurobloc® (type B preparation) per each of these flexors: carpi ulnaris, digitorum superficialis, digitorum profundus For pre-treated patients only: the most recent injection with Botulinum Toxin must have been maximal 60 Units BOTOX® or 240 Units Dysport® or 2400 Units Neurobloc® (type B preparation) for flexor carpi radialis Main Spasticity of any other origin than stroke Previous treatment with Botulinum Toxin of any serotype and for any body region within the 4 months prior to Screening (Visit 1, Day -7) Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region Previous or planned treatment with phenol or alcohol-injection in the target limb Previous surgical treatment of spasticity in the target muscle(s) Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch Severe atrophy of the target limb muscles
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-70.0, Upper Extremity Spasticity Stroke Acquired Brain Injury Minimum 6 months post injury/insult with unilateral upper limb spasticity of the elbow, wrist and/or finger flexors Preinjection Modified Ashworth scores > 2 in at least one of the following areas: elbow, wrist, or finger flexors Subjects must meet for CMA Hand Impairment Scale Stage 2 and be able to complete Task 3 (thumb to index finger) of the CMA Hand Impairment Scale Stage 3, or demonstrate 50% gross grasp to be included Botulinum toxin A (Botox®) stable patients (have received at least two prior doses of the agent with first dose occurring at least 6 months prior to study enrollment) Able to answer reliably to yes/no questions Able to follow reliably 1-step instructions Written informed consent Females enrolled in this study who are of childbearing age will be required to use adequate measures of birth control for the entire study period. Those who do not agree will be excluded Uncontrolled, clinically significant medical condition other than the condition under evaluation Severe, fixed joint contracture in the affected arm. Patients with mild contracture that does not significantly impact function will be included based upon the assessment of the PI Known allergy or sensitivity to any of the components in the study medication Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment Treatment with botulinum toxin of any serotype for any reason in less than 3 months prior to initial date of injection for the study Any medical condition that may put the subject at increased risk with exposure to botulinum toxin type A including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function Evidence of recent alcohol or drug abuse Infection or skin disorder at an anticipated injection and/or electrical stimulation sites Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-70.0, Stroke Male or female, 18 to 70 years of age Written informed consent Written Authorization for Use and Release of Health and Research Study Information has been obtained Medically stable condition in the investigator's opinion History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension Mini-Mental State Exam (MMSE) >24 If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment Ability to follow study instructions and likely to complete all required visits Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months Previous therapy with BOTOX® or any other botulinum toxin serotype for any condition within the last 12 months Phenol or alcohol block in the study limb within 6 months of study enrollment visit History (within 3 months of qualification) of or planned (during study period) casting of the study limb Current treatment with an intrathecal baclofen pump In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months Presence of fixed contracture of the study limb impairing functional activity Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity) Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-999.0, Alcohol Withdrawal Delirium Meet Diagnostic and Statistical Manual, 4th version, revised (DSMr-IV) for alcohol withdrawal syndrome (AWS) Be an inpatient at St. Mary's Medical Center (SMMC) or Miller Dwan Medical Center (MDMC) at time of study enrollment Have an alcohol withdrawal score as measured by standard SMMC or MDMC inpatient protocol sufficient to trigger the use of benzodiazepine withdrawal therapy Agree to abstain for alcohol for duration of study Be able to provide informed consent The patient must not have any other active drug dependence in addition to alcohol Be unwilling or unable to forgo alcohol for the duration of the study Be using baclofen at the time of study enrollment Be using benzodiazepines for any reason other than acute alcohol withdrawal syndrome at time of study enrollment have known baclofen or benzodiazepine sensitivity Be unable to take oral (PO) meds Be unable to complete one of two consenting procedures Be pregnant or breastfeeding Have a serum creatine level > 2.0 Have a history of non alcoholic withdrawal seizures
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 19.0-65.0, Rabies Subjects free of obvious health-problems or with stable condition Male or female subjects aged ≥19 to ≤65 years BMI between ≥18 and ≤30 kg/m2 Prior history of active or passive rabies immunization Clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator History and/or family history of clinically significant immunodeficiency or auto-immune disease Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 1.0-1.5, Rabies Male and female 12-18 months old toddlers will be included in the study if they are in good health at time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator are available for all the visits scheduled in the study have been granted a written informed consent signed by their parents a history of rabies immunization a history of Japanese encephalitis immunization or disease a significant acute or chronic infectious disease at the time of enrollment fever > 38.0 degree C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment being under treatment with parenteral, oral and/or inhaled corticosteroids, immunosuppressive drugs or other specific anti-inflammatory drugs or having taken chloroquine during the two months period before enrollment administration of any vaccine within the past 14 days before enrollment known immunodeficiency or an autoimmune disease known hypersensitivity to neomycin, tetracycline, amphotericin-B planned surgery during the study period being enrolled in any other investigational trial contemporaneously
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 1.0-3.0, Malaria Malaria Infection Males or females aged greater than or equal to 1 to less than 4 years Known residents of the village of Bancoumana, Mali or its surrounding area Good general health as determined by means of the screening procedure Available for the duration of the trial (24 months from enrollment) Willingness to have child participate in the study as evidenced by parents/legal guardians signing or fingerprinting the informed consent document Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, chronic infectious or renal disease by history, physical examination, and/or laboratory studies including urinalysis Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer or the parent/legal guardian to understand and cooperate with the study protocol Pre-existing known autoimmune diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia Laboratory evidence of possible autoimmune disease determined by anti-dsDNA titer that equals or exceeds 25 IU Laboratory evidence of liver disease (alanine aminotransferase [ALT] greater than the upper limit of normal of the testing laboratory) Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing confirmed by repeat testing) Laboratory evidence of hematologic disease (absolute leukocyte count less than 3000/mm(3) or greater than 14,500/mm(3), absolute lymphocyte count less than 1000/mm(3), platelet count less than 120,000/mm(3), or hemoglobin less than 8.5 g/dL) Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing History of a severe allergic reaction or anaphylaxis
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 4.0-18.0, Chronic Constipation Less than 2 per week defecation Fecal incontinence Retentive behavior Pain at defecation and Hard stools Medication use (calcium, antacid, diuretic and hematinic) Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-60.0, Rabies Aged 18 to 60 years on the day of Provision of a signed Informed Consent Form Able to attend all scheduled visits and comply with all trial procedures For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence for at least 4 weeks prior to each vaccination, until at least 4 weeks after each vaccination) Entitlement to national social security For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 21.0-65.0, Stroke Demographics: 21 to 65 years, within 12 months of first, single clinical stroke (ischaemic or haemorrhagic) Moderate to severe upper extremity (UE) weakness post stroke Fugly-Meyer motor score of the upper limb < 40 Upper limb motor power MRC grade 3 or less /5 in at least 1 arm region Able to give own consent and understand simple instructions and learn through practice Resting brain states determined by FMRI Recurrent stroke Previous brain surgery Spasticity of Modified Ashworth scale > 2 Fixed contracture of any upper limb joint Ataxia, dystonia or tremor of the involved upper limb or previous cervical myelopathy Upper limb pain or painful joints in upper limb Severe cognitive impairment (Abbreviated Mental Test <7/10), or severe aphasia which may affect ability to participate in training . History of seizures in the past 12 months Severe left neglect
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-999.0, Obesity African American (3 of 4 grandparents are of African Descent) Lives in designated census area No plans to move in the next two years Has no medical condition that would limit participation in moderate intensity exercise including life-threatening illness (e.g., immobile, severely disabled, or bed ridden) Available and able to participate in measures and intervention activities over the next 2 years Extreme Blood Pressure and/or Blood Glucose levels Unable to take a brisk, 30-minute walk
|
1
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-999.0, Rabies Prevention Rabies Exposure Laboratory personnel, epidemiologists, EISOs, veterinary students, interns, and other first responders at CDC; other CDC employees; and healthy volunteer adults. Persons who contact the study coordinator will be assessed for possible occupational exposure to rabies using the risk assessment form (appendix E). The volunteers reporting occupational exposure will be selected to enter the study Male or nonpregnant females (as indicated by a negative urine pregnancy test prior to first dose of vaccine), aged 18 years and older Women of childbearing potential who are at risk of becoming pregnant must agree to practice adequate contraception (i.e., barrier method, abstinence, or licensed hormonal methods) for the entire study period Be in good health, as determined by vital signs (pulse, blood pressure, oral temperature), medical history, and a targeted physical examination based on medical history Able to understand and comply with planned study procedures Provide informed consent prior to any study procedures and be available for all study visits Have health insurance Have a known allergy to PCECV Have a known allergy or sensitivity to eggs or latex (in the stopper) Have a positive urine pregnancy test prior to first vaccine dose (female of childbearing potential age) Are immunosuppressed as a result of an underlying illness or treatment Have active neoplastic disease or a history of any hematologic malignancy Are using oral or parenteral steroids, high-dose inhaled steroids (>800 μg/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs Have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study Have an acute illness that is accompanied by an oral temperature greater than 100.4°F, within 1 week of vaccination Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to enrollment in this study, or expects to receive an experimental agent during the 1st month of the study period Have any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 0.167-17.0, Encephalitis Male or female healthy children and adolescents aged >=2 months to <18 years at the time of first vaccination Written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable Female subjects: either no childbearing potential or negative pregnancy test. For females after menarche willingness to practice a reliable method of contraception The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule. Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7 Clinical manifestation or history of any Flavivirus disease Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study History of immunodeficiency or immunosuppressive therapy Known HIV, HBV or HCV infection History of hypersensitivity reactions to other vaccines Acute febrile infection at each visit during which the subject receives a vaccination Active or passive immunization within 1 week before and 1 week after each IC51 vaccination
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-50.0, Diarrhea Male or female age ≥18 and ≤ 50 years General good health, without clinically significant medical history, physical examination findings or clinical laboratory abnormalities per clinical judgment of PI Negative serum pregnancy test before first (visit V0) and before challenge (visit C0) for female subjects of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female subjects unable to bear children must have this documented (e.g. tubal ligation or hysterectomy) or must have negative pregnancy tests Willingness to participate in the study after all aspects of the protocol have been explained and written informed consent obtained Completion of a training session and demonstrated comprehension of the protocol procedures, knowledge of ETEC-associated illness, and by passing a written examination Availability for the study duration, including all planned follow-up visits Presence of a significant medical or psychiatric condition which in the opinion of the investigator precludes participation in the study. Some medical conditions which are adequately treated and stable would not preclude entry into the study. These conditions might stable asthma controlled with inhalers or mild hypertension stably controlled with a single agent Significant abnormalities in screening hematology, serum chemistry or urinalysis as determined by PI or PI in consultation with the MM and sponsor Presence in the serum of HIV antibody, HBsAg, or HCV antibody Evidence of IgA deficiency (serum IgA < 7 mg/dl or limit of detection of assay) Evidence of current excessive alcohol consumption or drug dependence Evidence of impaired immune function BMI <19, >34 Recent vaccination or receipt of an investigational product (within 30 days before vaccination) Intention to donate blood or blood products for one month following the completion of study participation (note: The Red Cross will not allow blood donations for 1 year following participation in an investigational research study) Any other which, in the investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study, or the results of the study
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-60.0, Thyroidectomy Distress Surgery (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter (a) previous neck operations (b) age <21 or >65 years (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 21.0-80.0, Multiple Sclerosis diagnosis of non-relapsing multiple sclerosis (primary progressive MS, secondary progressive MS) reduced use of one of the hands because of MS ability to pick up and release a small object with the more-affected hand when requested can travel to the treatment program at the University of Alabama at Birmingham (UAB) can undergo treatment for 2 weeks (Monday-Friday), 3.5 hours per day can undergo MRI scan any kind of medication used for MS is allowed except spasticity medicine disease relapse in the past 3 months pregnancy marked pain with arm movement severe uncontrolled medical illness simultaneous treatment with another form of physical therapy
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-55.0, Rabies Male or female subject aged ≥18 to ≤55 years Subjects free of obvious health-problems or with stable conditions or medications Body mass index between ≥18 to ≤30 kg/m2 Abstinence from sexual intercourse or use of adequate contraception from the date of screening up to Day 90 Male subjects must agree that they will not donate sperm from the first check-in until Day 90 Subject signed written informed consent Prior history of active or passive rabies immunization Clinically significant acute illness or infection including fever (≥38 °C) within 2 weeks before first dosing History and/or family history of clinically significant immunodeficiency or auto-immune disease Planned immunization with live vaccines during the coming 3 months after first dosing Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 4.0-12.0, Angelman Syndrome Age between 4 years and 12 years (i.e., before the 13th birthday) Molecular confirmation of the diagnosis of AS, which may abnormal methylation studies or UBE3A mutation analyses only subjects with a molecular diagnosis will be allowed to enroll Not on LD, CD, or any dopamine agonists in the 2 weeks prior to participation Co-morbid disorders that may be associated with developmental or cognitive delays Poorly controlled seizures An average of more than 2 clinical seizures per month in the 12 months prior to enrollment Use of medications that may interact with LD/CD including atypical antipsychotics (aripiprazole, asenapine, iloperidone, olanzapine, paliperidone, risperidone, ziprasidone), monoamine oxidase inhibitors (isocarboxazid, phenelzine, selegiline, tranylcypromine), or phenytoin within the last 14 days, or other investigational interventions within the past 3 months Presence of cardiovascular disease or instability, respiratory disease, liver disease, peptic ulcer disease, renal impairment, or hematological disorders Pregnancy
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-60.0, HIV Rabies HIV infected patients 18-60 years of age Ever received primary rabies immunization currently have any active opportunistic infections have received blood or blood product within previous 3 months history of allergy to vaccine or any vaccine components currently received anti-malarial drugs
|
1
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 2.0-50.0, Malaria Consenting adult males aged 18-50 years in good health and healthy children aged 2-6 years.with consenting parents Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness Severe malnutrition Hypersensitivity to HDCRV History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone History of splenectomy Haemoglobin less than 9.0 g/dL, where judged to be clinically significant in the opinion of the investigator Serum Creatinine concentration greater than 70 mol/L, where judged to be clinically significant in the opinion of the investigator Serum ALT concentration greater than 45 U/L, where judged to be clinically significant in the opinion of the investigator Blood transfusion within one month of enrolment History of vaccination with previous experimental malaria vaccines Administration of any other vaccine or immunoglobulin within two weeks before vaccination
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-999.0, Muscle Spasticity Adult patients with upper limb spasticity following a stroke Eligible to receive botulinum toxin Type A No previous botulinum toxin Type A therapy
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 30.0-80.0, Stroke for patients wth stroke Age 40-80 years sustained a single stroke between 3-24 months prio t study leading to upper limb paresis have at least Stage 3/7 arm control (mild to moderate motor deficits) on the Chedoke-McMaster Scale <81 yrs old to minimize confounding effects of age-related changes in sensorimotor functions for patients wth stroke other neurological or orthopaedic problems that may interfere with interpretation of results significant deficits in attention, constructional skills, neglect and apraxia shoulder subluxation, arm pain lack of endurance as judged by a physician undergoing other therapy, surgery or medical procedures within the study period for healthy control subjects Age 40-80 years for control subjects any neurological or orthopaedic problems that may interfere with interpretation of results
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 18.0-60.0, Meningococcal Disease Meningococcal Meningitis Typhoid Yellow Fever Rabies Japanese Encephalitis Female and male subjects who must be healthy and must be Between 18 and 60 years of age inclusive and who have given their written informed consent Available for all visits and telephone calls scheduled for the study In good health as determined by medical history, physical examination and clinical judgment of the investigator For female subjects, having a negative urine pregnancy test Individuals not eligible to be enrolled in the study are those who are breastfeeding who have a personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow fever, dengue fever, West Nile virus infection) who have been immunized with any of the study vaccines within the last five years as determined by medical history and/or vaccination card who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period (Exception: Influenza vaccine may be administered up to 15 days prior to each study immunization and no less than 15 days after each study immunization) who have received an anti-malaria drug, up to 2 months prior to the study who have experienced, within the 7 days prior to enrollment, significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment who have any serious acute, chronic or progressive disease such as
|
0
|
A 28-year-old female with neck and shoulder pain and left hand and arm paresthesias three weeks after returning from a trip to California where she attended a stray animal recovery campaign. Her physical exam was unremarkable except for slight tremors and almost imperceptible spasticity. She was prescribed NSAIDS and a topical muscle relaxant. She was brought in to the ER three days later with spastic arm movements, sweating, increasing agitation and anxiety, malaise, difficultly swallowing and marked hydrophobia, and was immediately hospitalized.
|
eligible ages (years): 15.0-60.0, Efficacy of the New CPRV Healthy Can visit according to the protocol Fever Acute illness History of rabies vaccination Allergic to the vaccines' component Immunosuppressive conditions such as HIV infection, transplantation, chronic renal failure, received steroid or immunosuppressive drugs and anti-malarial drugs within previous two months or any blood products within previous three months Female participant must not be pregnant All female participant must have urine pregnancy test negative prior to participate the study
|
0
|
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.