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A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 60.0-90.0, Disorder of Aging Aged 60 years; diagnosis of failure / vitamin D, preserved cognitive status, disability accepting participate and are not included in any of the excluded from the study in the elderly using vitamin D supplements; anticonvulsant drugs or for the treatment of HIV / AIDS; diagnosis of type I diabetes mellitus, nephrotic syndrome, acute or chronic renal failure, liver disease, hypothyroidism, hyperthyroidism, history of cerebrovascular accident (CVA) or acute myocardial infarction (AMI) Vascular past 6 months and chronic consumptive diseases, alcoholic or smoker chronic | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-60.0, Multiple Sclerosis, Secondary Progressive written informed consent obtained with Multiple Sclerosis, and with secondary progressive disease course screening Expanded Disability Status Scale (EDSS) score between 4.0 and 6.5 inclusive screening timed 25 foot walk (average of two trials) lof 9 seconds or more Long QT interval, defined as corrected QT interval of more than 470 msec in men and more than 450 msec in women on baseline ECG Patients with known long-QT syndrome Patients with known ventricular arrhythmia Patients with a known electrolyte disturbance Patients undergoing treatment with drugs that increase the QTc interval Patients undergoing treatment with drugs that inhibit CYP3A4, in particular: Ketoconazole, Fluconazole, Erythromycin, Clarithromycin, Ritonavir Patients with a history of breast cancer or carcinoma in situ Patients with known renal insufficiency Patients with known allergy or other intolerability to domperidone Patients currently using Fampridine or 4-aminopyridine | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 70.0-999.0, Subclinical Hypothyroidism men and women aged 70 and older TSH between 4.5 and 19.9 mU/L as an outpatient ability to provide informed consent Laboratory Tests TSH <4.5 mU/L or >20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range thyroid peroxidase (TPO) antibody positive abnormal liver function tests (LFTs >3 x upper limit of normal) hemoglobin <11 g/dL Surgeries or Procedures thyroid surgery pituitary surgery bariatric surgery bowel resection | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-65.0, Latent Hypothyroidism latent hypothyroidism Factors that Alter Thyroxine and Triiodothyronine Binding in Serum Increased thyroxin-binding globulin Decreased thyroxin-binding globulin Binding inhibitors Inherited Salicylates Pregnancy Androgens Furosemide Neonatal state Anabolic steroids | 1 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-100.0, Pancreatic Cancer Newly diagnosed adenocarcinoma of the head, neck, or uncinate process of the pancreas Stage I or II disease Surgically resectable disease (R0 or R1) by spiral CT scan No distant metastases ECOG Performance Status of 0 to 1 Adequate organ function as defined by study-specified laboratory tests Must use acceptable form of birth control Signed informed consent form Willing and able to comply with study procedures Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune, psychological or other medical conditions Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), CNS or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis) Patients who have been diagnosed with another cancer in the past 5 years (except for superficial bladder cancer, non-melanoma skin cancers, or a low grade prostate cancer not requiring therapy) Patients who have received therapy for pancreatic cancer Using systemically active steroid use Patients who have known history of infection with HIV, hepatitis B, or hepatitis C Patients on home oxygen Patients with oxygen saturation of <92% on room air by pulse oximetry Pregnant or lactating Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Prostate Cancer Have metastatic castration-resistant prostate cancer Life expectancy of greater than 3 months ECOG performance status 0 or 2 Age ≥18 years Have measurable disease Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator) Ability to take oral medication Patients must have adequate organ and marrow function defined by study-specified laboratory tests Must use acceptable form of birth control while on study Ability to understand and willingness to sign a written informed consent document Known history or evidence of brain metastases Prior chemotherapy for metastatic disease in castration-resistant prostate cancer Had surgery within 4 weeks prior to the first dose of study drug Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug Systemic steroids within 1 weeks prior to the first dose of study drug Had prior enzalutamide, ARN-509, or galeterone therapy Have moderate or severe cardiovascular disease Have a history of a seizure Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-65.0, Diabetes Mellitus Healthy or treatment naive type 2 diabetes euthyroid subjects, with a micronodular texture of the thyroid gland Recreationally active With stable body weight and diet during the last two months Any systemic disease(besides glucose abnormalities) Any medication therapy Diabetic complications | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-999.0, Group B Streptococcus Age ≥ 18 years Pregnant women presenting for unplanned obstetrical care at a participating clinical study site Gestational age between 21 6/7 and 36 6/7 weeks Subject has not participated in the study before Subject agrees to complete all aspects of the study and provide informed consent in accordance with applicable regulations Signs and/or symptoms suggestive of preterm labor, whereby the managing clinician suspects preterm labor Uterine contractions (with or without pain) Intermittent lower abdominal pain, dull backache, pelvic pressure Vaginal bleeding during the second and third trimester Menstrual-like intestinal cramping (with or without diarrhea) Exposure to antibiotics within 1 week prior to enrollment (15) Known GBS bacteriuria at the time of enrollment Prior history of neonatal GBS sepsis | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 35.0-79.0, Osteoarthritis, Knee Planned unilateral TKA done at Verdun Hospital Capacity to communicate in French or English Complications during or after the surgery Inability to perform the tests due to other diseases Contraindications to cryotherapy such as Raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 18.0-40.0, Streptococcus B Carrier State Complicating Pregnancy Age: 18 to 40 Origin: Arab Gestational age: 34 to 40 Rupture of membranes Women in active labor who has had one or more vaginal examinations | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 50.0-64.0, Chronic Obstructive Pulmonary Disease for patients with COPD will be Signed informed consent prior to initiation of study-mandated vaccination Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD Patients meeting GOLD Classification of Stage C or Stage D COPD Patients 50 years old years old for Healthy participants will be Signed informed consent prior to initiation of study-mandated vaccination No active symptoms of lung disease FEV1/FVC in the normal range > 70% age predicted value Severe allergy to eggs Severe reaction to past doses of influenza vaccine Guillian-Barre syndrome Currently recieving dialysis Current, active, treatment for cancer History of transplant (allograft) Dementia or Alzheimer's disease diagnosis Prior diagnosis of HIV or AIDS Moderate to severe pulmonary hypertension Serum AST/ALT > 3x the upper limit of normal | 0 |
A 56-year old Caucasian female complains of being markedly more sensitive to the cold than most people. She also gets tired easily, has decreased appetite, and has recently tried home remedies for her constipation. Physical examination reveals hyporeflexia with delayed relaxation of knee and ankle reflexes, and very dry skin. She moves and talks slowly. | eligible ages (years): 17.0-70.0, Cough chronic cough group cough lasting ≥ 8 weeks,characterized by irritating dry cough sensitive to fumes，dust,the odorous and cold air with normal chest x-rays. 4.17-70 years old without smoking history. healty controls group: 1.17-70 years old. 2.without smoking hitory or stop smoking for more than 2 years. 3.without chronic cough. 4.without chronic respiratory diseases. 5.without chronic heart, liver, kidney,and autoimmune disease. 6.with normal chest x-rays. 7.with normal pulmonary ventilation function,and histamine challenge test showed negative result chronic cough group and healty controls group with respiratory tract infection within 8 weeks with chronic respiratory diseases or severe heart, liver, kidney,and autoimmune disease using Angiotensin-Converting Enzyme Inhibitors(ACEI),bronchodilators,glucocorticosteroid,antihistaminics within one week women during pregnancy or lactation patients with malignant tumours | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, HIV Infections Co-existing Condition Patients with the following are excluded Neuropsychological (NP) impairments more severe than described in the Criteria Evidence of nervous system dysfunction being caused by factors other than HIV infection, including history of head trauma, multiple sclerosis, epilepsy, or presence of concurrent central nervous system (CNS) infections or neoplasms, e.g., toxoplasmosis, primary or metastatic CNS lymphoma, progressive multifocal leukoencephalopathy, cryptococcal or other fungal meningitis, and CNS tuberculous infections Lymphoma or other tumor requiring cytotoxic chemotherapy Concurrent Medication Excluded Other antiretroviral agents Patients with the following are excluded AIDS or advanced ARC | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, West Nile Virus In order to participate in this clinical trial, all subjects (or legal representative) must provide written informed consent. Only patients meeting entry will be enrolled. Eligible subjects must fall into one of two categories A. Hospitalized patients greater than or equal to 18 years of age with encephalitis and/or myelitis as defined below New neurologic abnormality Asymmetric extremity weakness without sensory abnormality; or Other neurologic abnormality (including altered level of consciousness, dysarthria and dysphagia) plus fever (subjective or objective) within the previous 4 days AND CSF examination within the previous 96 hours showing Absence of organism on gram or fungal stain White blood cell count greater than or equal to 4 per mm(3) corrected for significant red blood cell contamination Ratio of CSF: plasma glucose of greater than or equal to 40% (CSF glucose/plasma glucose greater than or equal to 0.4) Unable to obtain valid informed consent History of intolerance (including anaphylaxis) to IVIg or related compounds Known history of IgA deficiency Known history of hypersensitivity to maltose History of (or at time of study entry) hyperviscosity syndrome including but not limited to Waldenstrom's macroglobulinemia Multiple myeloma Total white blood cell count greater than 80,000/mm(3) Hematocrit greater than 55% Platelet count greater than 700,000/mm(3) | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, HIV Infections HIV uninfected At low risk for HIV infection Willing to receive HIV test results Good general health Acceptable methods of contraception for females of reproductive potential Hepatitis B surface antigen negative Anti-hepatitis C virus antibody (anti-HCV) negative or negative HCV PCR if anti-HCV is positive Meets educational requirements of the study HIV vaccines or placebos in prior HIV vaccine trial Immunosuppressive medications within 168 days prior to first study vaccine administration Blood products within 120 days prior to first study vaccine administration Immunoglobulin within 60 days prior to first study vaccine administration Live attenuated vaccines within 30 days prior to first study vaccine administration Investigational research agents within 30 days prior to first study vaccine administration Subunit or killed vaccines within 14 days prior to first study vaccine administration Allergy treatment with antigen injections within 30 days prior to first vaccine administration Current tuberculosis prophylaxis or therapy Serious adverse reaction to a vaccine. A person who had an adverse reaction to pertussis vaccine as a child is not excluded | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 17.0-65.0, Spinal Cord Injuries Injured subjects Complete or incomplete acute SCI between C0 and T11 Admitted within 48 hours of injury Undergoing spinal decompressive surgery Undergoing lumbar puncture for spinal anesthetic or myelography Neurologically intact Pre-existing neurodegenerative disorder Associated head or spine injury | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Pneumococcal Meningitis Adults (> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit Allergy to one of the antibiotics used in the study | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, HIV Infections Lymphoma, AIDS-Related Adult (18 years old or older) HIV-infected patient HIV infected by OraQuick rapid test using saliva, venipuncture whole blood, or fingerstick whole blood; or by reactive ELISA and Western Blot as determined by an outside CLIA-approved laboratory facility or by NIH Clinical Pathology Laboratory or SAIC-Frederick Inc Monitoring Laboratory. HIV infection as determined by an outside CLIA-approved laboratory facility will be verified by a standard HIV-1 ELISA with Western Blot confirmation prior to brain biopsy Evidence of contrast-enhancing focal brain lesion(s) as seen on MRI or CT Willingness to give informed consent and provided by Durable Power of Attorney. In the event that no Durable Power of Attorney has been designated and the patient is unable to do so, the NIH Ethics Committee will be consulted. All patients must designate a Durable Power of Attorney in order to participate in the study Willingness to undergo the procedures involved in the diagnostic evaluation: lumbar puncture, FDG-PET scan, 201Tl-SPECT scan, and brain biopsy Permit the storage of blood, CSF, and tissue samples for future research use Willingness to undergo HLA testing Previous PCNSL History of prior malignancy other than PCNSL unless in remission for 1 year or longer; non-melanoma skin cancer and Kaposi's sarcoma excepted History of previous diagnosis of toxoplasmic encephalitis or other CNS infection causing focal contrast-enhancing brain lesions Pregnancy or currently breast feeding Have any other condition that the research team considers a contraindication to participating in the study, e.g. severe cardiac, renal, or pulmonary dysfunction Weight greater than 400 lb for PET and 500 lb for SPECT (limit of the gantry) | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-14.0, Pneumococcal Meningitis All children from 0 up to 14 years with diagnosis of confirmed or probable pneumococcal meningitis or with diagnosis of suspected bacterial meningitis without bacterial or viral isolation will be included into the study | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-64.0, Back Pain Need a lumbar or cervical myelogram as part of routine care Not needing a myelogram in the cervical or lumbar spine | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 8.0-18.0, Migrainous Headache Males or Females age 8-18 years Girls 11 years or older must have a negative urine/serum pregnancy test Diagnosis of pediatric migrainous headache. The for pediatric migraine headache based on the most recent ICHD are listed below. The requirement of 5 attacks (A) will not be required for this study, this making the diagnosis migrainous headache. As described elsewhere in the protocol, this change is required to make the study applicable to ED patients who require treatment before five attacks have occurred Evidence that headache is due to a secondary underlying disorder based on history or physical examination Pregnant or lactating females Any investigational drug use within 30 days Known to have a contraindication to metoclopramide or valproic acid such as pregnancy, liver disease, hematologic disease, or metabolic disease Have used metoclopramide (or other antidopaminergic medications) or valproic acid within two days of presentation Severe developmental disorders or mental retardation if insufficient information can be obtained to make a clear diagnosis of migraine or judge headache severity If patients re-present to the ED, they can not be re-enrolled | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Minor Head Injury Traumatic Brain Injury head injury, nausea, vomiting no head injury | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Cardiac Arrest Arrhythmia Cardiac Arrest Patients 18 years and older with cardiac arrest in the hospital and successfully resuscitated, or with cardiac arrest out of the hospital and successfully resuscitated ICD patients Patients 18 years and older Who are undergoing elective procedure in the electrophysiology laboratory for placement of a cardiac defibrillator and who will most likely undergo induction of ventricular arrhythmia as part of the procedure Cardiac Arrest Cardiac arrest and a known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery CNS infection Skull defects and scalp diseases that are not amenable to standard EEG testing ICD patients Known pre-existing cerebral pathology such as brain tumor, cerebral hemorrhage, encephalitis or immediately post-op neurosurgery CNS infection Skull defects and scalp diseases that are not amenable to standard EEG testing | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 20.0-65.0, Post-Traumatic Stress Disorder Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) will be used for diagnosis Pathologic condition: Patients who experienced a motor vehicle accident (MVA) with severe or potential severe physical injury more than 3 months ago but less than 12 months ago Patients aged 20 and <65 at the time of signing the Informed consent Male and female patients Inpatient/outpatient status: Both are permitted Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own) Patients whose combined score of the CAPS-SX standard B, C, and D is over 50 Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia [simple phobia], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase) Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD Patients receiving disability payments due to PTSD or other psychiatric diseases Patients currently engaged in compensation litigation whereby personal gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders Patients who meet the DSM-IV-TR for substance abuse or dependence (alcohol or drugs) within 6 months of Week -4 (start of baseline phase) Patients with history of a suicide attempt within 6 months before Week -4 (start of baseline phase), or have, in the opinion of the investigator, "C. high risk of suicide" according to the MINI at Week -4 Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant Patients receiving electro-convulsive therapy (ECT) prior to Week -4 (start of baseline phase) Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase) Patients with a history or complication of manic psychosis | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Chiari Malformation Type I Age >18 years Clinical Diagnosis of Chiari Type I Malformation Radiogrpahic evidence of downward tonsillar herniation (displacement of the lower part of the cerebellum below the level of the skull) Signed Written Informed Consent Presence of Hydrocephalus or previous CSF diversion procedure, such as shunt Prior operation on the posterior cranial fossa Inability to understand the informed consent or unwillingness to participate in the study Inability to return for follow-up evaluation 3 months after the surgery Evidence of spinal dysraphism Allergy or history of allergic reaction to Duragen, Duraguard, or their components Pregnancy as documented by a urine or blood test | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-75.0, Spinal Procedure Requiring Dura Incision Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria) Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds Active spinal and/or systemic infection Patient requires additional spinal surgery within the study time period Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure Patient has a pre-existing external lumbar CSF drain or internal CSF shunt Patient is participating in a clinical trial of another investigational device or drug Patient with creatinine > 2.0 mg/dL Patient with total bilirubin > 2.5 mg/dL Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or at the time of surgery | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.167-15.0, Bacterial Meningitis All children aged ≥ 2 months, admitted to Queen Elizabeth Hospital, Blantyre, Malawi, with possible or confirmed acute bacterial meningitis Age less than two months Trauma Relevant underlying illness such as intracranial shunt, previous neurological disease (cerebral palsy, Down's syndrome) Previous permanent hearing loss (not conductive hearing loss) if known Immunosuppression except HIV infection | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-45.0, Familial Mediterranean Fever Fulfilling the Tel Hashomer for the diagnosis of FMF [5] Suffering from episodes of exertional leg pain and or exertional ankle edema 18-45 years old On a stable (≥ 2 weeks) dose of oral colchicine therapy Non-smokers with known peripheral vascular disease (PVD) and/or multiple risk factors for PVD (such as diabetes, hypertension, hyperlipidemia) Suffering from muscular or neurological diseases not related to FMF With elevated serum creatinine / liver enzymes/ creatine phosphokinase (CPK) levels Suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for MRI | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 3.0-999.0, Pathological Processes in the Posterior Fossa Dura Defects Preoperative Subjects undergoing elective craniotomy / craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformations, and Chiari 1 malformations) that result in dura defects requiring dura substitution for closure and who are able and willing to comply with the procedures required by the protocol Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures Age >= 3 years, either gender Intraoperative Surgical Wound Classification Class I and Risk Index Category (RIC) <= 2. Penetration of mastoid air cells during partial mastoidectomy is permitted and will be recorded A patch of autologous fascia or pericranium or suturable collagen-based dura substitute was cut to size and then sutured into the dura defect The hem of native dura exposed along and under the craniotomy edge is wide enough to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product Preoperative Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period Subjects with a dura lesion from a recent surgery that still has the potential for cerebrospinal fluid (CSF) leakage unless it can be expected that the lesion will be excised completely, including all old suture holes Chemotherapy scheduled within 7 days following surgery Radiation therapy to the head scheduled within 7 days following surgery Subjects with severely altered renal (serum creatinine > 2 mg/dL) and/or hepatic function [ALT, AST > 5 x upper limit of norm (ULN)] Evidence of an infection indicated by any one of the following: fever > 101°F, white blood cell (WBC) count < 3500/μL or > 13000/μL, positive blood culture, positive chest X-ray. A positive urine culture (> 10^5 colony-forming units (CFU)/mL) leads to unless acute cystitis is the sole cause. Evidence of infection along the planned surgical path. A WBC count of < 20000/μL is permitted if the patient is being treated with steroids in the absence of all the other infection parameters Conditions compromising the immune system; existence of autoimmune disease Known hypersensitivity to aprotinin or other components of the investigational product Non-compliant or insufficient treatment of diabetes mellitus [glycosylated hemoglobin (HbA1c) > 7.5%] | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-75.0, Elective Cranial Procedures With Dural Incision Patient is between 18 and 75 years of age Patient is scheduled for an elective cranial procedure that entails a dural incision Evidence of intraoperative non-watertight closure | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 6.0-14.0, Status Epilepticus Seizures Children presenting convulsing to the pediatric emergency or developing seizure while in casualty Age 6-14 years Known hypersensitivity to any benzodiazepine Child has received any parenteral anti-convulsant within 1 hr prior to enrollment Presence of severe cardio-respiratory compromise or cardiac arrhythmias Presence of upper respiratory tract infection Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Acute Renal Failure SIRS Sepsis Critically Ill Multiple Organ Dysfunction Syndrome Critically ill, postoperative/posttraumatic patients with threatening acute renal failure Life expectancy < 24 hours Participation in other trials Known or suspected pregnancy | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Posttraumatic Stress Disorder Diagnosis of Posttraumatic Stress Disorder Diagnosis of psychosis, drug or alcohol dependency/abuse Unable to fill in questionnaires in Dutch Color blindness (Stroop test) | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-65.0, Posttraumatic Stress Disorder willingness to participate in a naturalistic treatment study using paliperidone and in two fear conditioning tests, one at baseline and one at the end of the 6 weeks treatment study We will PTSD subjects on medications (possible medications antidepressants, benzodiazepines) who have no or only partial treatment response. Paliperidone will be added to the existing treatment regime which will remain unchanged during the study period. PTSD subjects will have a minimum score of 50 on the Clinician-Administered PTSD Scale (CAPS; Blake et al, 1995) a comorbid diagnosis of bipolar illness, schizophrenia or other psychotic disorders, acute or chronic suicidality, acute or chronic unstable medical conditions (including severely impaired hepatic function as indicated with abnormal PT and PTT, abnormal CBC, and liver enzymes more than 50% above the upper normal range, not well controlled blood pressure) current diagnosis of substance abuse or dependence unsuccessful treatment history with paliperidone known hypersensitivity to paliperidone or any of its inactive ingredients administration of any investigational drug up to 90 days before entry into the study intake of Class 1A (e.g., quinidine, procainamid) or Class III (e.g., amiodaronme, sotalol) antiarrhythmic medications, antipsychotics, antibiotics (e.g., gatifloxacin, moxifloxacin) (up to 90 days before entry into the study or during the study) subjects with a positive screen for drugs of abuse no startle or skin conductance response, or excessively high startle response to the startle probe (100 dB acoustic stimuli) during the pretest | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 16.0-999.0, Rhinitis, Allergic, Perennial Patients of mongoloid race residing in Japan who satisfy all of the following Patients having symptoms of perennial allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining informed consent and during the pretreatment observation period Patients with a positive skin reaction test or specific IgE antibody quantitation, and with a positive cytological examination of nasal discharge (eosinophils) or nasal challenge test Outpatients who are at least 16 years of age at the time of informed consent obtained Male or female Patients who have the ability to give written informed consent (informed consent of the guardian must also be obtained for patients younger than 20 years) Patients who can keep nasal allergy diary without fail Patients with coexisting tuberculous disease or lower respiratory tract infection, or patients who, at the time of registration, have acute upper respiratory tract infection, acute pharyngitis, acute amygdalitis etc Patients with coexisting infections or systemic mycosis for which there are no effective antibiotics Patients with unhealed nasal septum ulcers, nasal surgery scar, or nasal trauma Patients with a history of hypersensitivity to steroids or mometasone furoate Patients who are pregnant or nursing or who may be pregnant and patients or patients' partners who desire to become pregnant during the study period Patients with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension or other serious coexisting diseases and whose general condition is poor Patients also allergic to pollen and the pollen release season occurs during the study period Patients with vasomotor rhinitis or eosinophilic rhinitis Patients with a nasal condition which may interfere with efficacy evaluation of the investigational product Patients who develop disease affecting nasal symptoms during the pretreatment observation period, i.e., during the 7 days before actual registration | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 16.0-999.0, Perennial Allergic Rhinitis Patients with perennial allergic rhinitis meeting all of the followings Patients with symptoms of perennial allergic rhinitis, the severity of which is moderate or severer according to the severity grading provided in the "Guidelines for the Management of Allergic Rhinitis in Japan" (partly modified) with the 4-nasal symptom score of 4 or over at informed consent and during the pre-treatment observation period Patients with positive reaction to the eosinophil count in nasal discharge or nasal challenge test in addition to the skin test or specific IgE antibody test Outpatients aged 16 years or over at informed consent Patients in either sex Patients (or their legal representatives in case of patients aged under 20 years) capable of giving written informed consent Patients capable of recording nasal allergy diary every day Patients with a complication of tuberculous diseases or lower respiratory tract infections, and those with a complication of otorhinolaryngeal infections(acute upper respiratory tract inflammation, acute laryngopharyngitis, acute tonsillitis, etc.) requiring treatments judged by the investigator (subinvestigator) at the time of enrollment to randomization Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available Patients with a complication of recurrent epistaxis Patients with uncured nasal septal ulcer, operated nose or nasal trauma Patients with a history of hypersensitivity to steroids and any ingredients of the study drugs Pregnant, lactating or possibly pregnant patients or the patients who themselves or whose partners wish to become pregnant during the study Patients with severe hepatic or renal disorder, heart or blood disease, diabetes mellitus, hypertension, or other serious complication, suffering from problems with systemic condition Patients who have pollens as multiple allergens and the period from 7 days before enrollment to randomization to completion of the treatment period coincides with the period of scattering of relevant pollens Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis Patients with a complication of a nasal disease (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, or septal deviation) which may interfere with efficacy evaluation of the study drugs | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, West Nile Neuroinvasive Disease West Nile Virus Infection Encephalitis Meningitis Acute Flaccid Paralysis West Nile Fever Provide written informed consent Be >=18 years of age at the time of enrollment Have West Nile Fever defined as temperature >38°C, headache, AND positive diagnostic test for WNV Ribonucleic acid or Immunoglobulin M with serum or cerebrospinal fluid (CSF) OR have West Nile Neuroinvasive Disease (includes neurological signs and/or symptoms of West Nile meningitis, encephalitis, and/or acute flaccid paralysis), defined as • West Nile encephalitis (must meet a and b below) Encephalopathy (depressed or altered level of consciousness, lethargy, or personality change lasting 24 hours) CSF pleocytosis >=5 cells/mm^3 AND/OR | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Brain and Central Nervous System Tumors Breast Cancer Metastatic Cancer Meets 1 of the following Diagnosis of metastatic breast cancer with evidence suggestive of carcinomatous meningitis, with or without brain metastasis Other type of cancer with evidence suggestive of carcinomatous meningitis Meningeal syndrome without context of cancer No other prior cancers Not pregnant or nursing No prior intrathecal treatment At least 4 weeks since prior interferon No concurrent participation in another clinical trial | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 12.0-999.0, Vasomotor Rhinitis Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis Negative skin tests to a panel of allergens and positive histamine test within last 2 years History of symptoms related to defined VMR triggers Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit Chronic use of drugs that can cause rhinitis | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 5.0-15.0, Rhinitis, Allergic, Perennial Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen) Male or female outpatients aged 5 to 15 years at the time of providing informed consent Subjects for whom any of the main below is applicable will not be registered in this study Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics Subjects with repeated epistaxis Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Brain Injuries, Traumatic Injuries, Acute Brain TBI (Traumatic Brain Injury) Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS <9; b) AIS-head of ≥3, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis) | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Cerebrospinal Fluid Leaks Main (Positive response) • Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid Approach to the middle fossa: Subtemporal (+/ petrous apex drilling), pterional approach (any fronto temporal approach +/ orbitozygomatic deposition) Approach to the anterior fossa: Subfrontal (uni or bilateral) Approach to the midline posterior fossa (Negative response) Has the patient been subject to neurosurgery involving opening of the dura mater within the last 3 months? Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week? Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura mater which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks? The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial transfacial approaches with wide defect in the skull base? I.e. any of the following Trans basal approach Total petrosectomy Trans facial approach Trans sphenoidal approach | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, Perennial Rhinitis Seasonal Rhinitis All patients have to sign the informed consent or give verbal confirmation prior to their in the study Outpatient (external) male or female over 18 years and under 50 years Patients with active rhinitis (anterior or posterior rhinorrhea, sneezing, nasal congestion and itching) persistent (≥ 4 days a week for 4 consecutive weeks) or intermittent (< 4 days a week for ≤ 4 consecutive weeks) Patient with medical history of rhinitis 2 years prior to their participation in this study and whose nasal symptoms have been severe enough to require continuous or intermittent treatment (it requires a patient's symptoms need treatment at least for a 4 weeks period) Patient with the ability to understand the risks and benefits requirement while participating in the study and is able to accomplish the study treatment and with filling questionnaires and patient's diaries Patient with other nasal disease including: nasal polyps or nasal trauma recent Patient with intranasal malformations (cysts and fistulas of the nose dorsum, prenasal space malformation, midline dystrophy, arrhinea, abnormalities of the tear ducts), or other conditions such as; recent nasal biopsy, drug rhinitis Non-controlled asthma or who were under systemic corticosteroid treatment Patient with Chronic Obstructive Pulmonary Disease Medical history of respiratory infection or other disease including bronchitis, pneumonia, common cold, acute or chronic sinusitis, influenza, etc. within 30 days prior to its in the study Patient receiving antibiotic therapy for any acute illness during the past 14 days Patient vaccinated against pneumococcus, H1N1 & seasonal influenza (past 30 days) Patient required initiation or dose escalation immunotherapy. Immunotherapy is permitted if started 90 days ago and the patient received a stable dose during the last 30 days Patient has participated in another research study within 30 days preceding this visit Patient with medical history of hypersensitivity to steroids or any excipients of this class of drugs | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 7.0-15.0, Perennial Allergic Rhinitis Patients aged between 7 and 15 years Patients with a weight of at least 20 kg Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic Patients with a mean rhinorrhea score of at least 2 and a mean total score for the three major nasal symptoms [sneezing, rhinorrhea, and nasal congestion] of at least 4 on the basis of symptoms recorded in the nasal allergy diary during the observation period Patients with vasomotor rhinitis or eosinophilic rhinitis Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 Patients with a history of any of the nasal surgical procedures Patients who have a positive result for pollen antigens which are dispersed during the study period Patients who have a positive result for dog dander or cat dander antigen Patients with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-18.0, Head Trauma Children who had a radiography for head trauma | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 50.0-999.0, Seizures Pneumococcal Meningitis Adult patients > or = 50 years old Diagnosed of pneumococcal meningitis due to clinical characteristics plus a positive CSF Gram stain and/or a detection of pneumococcal antigen or PCR Suspected pneumococcal meningitis since it is an episode related to otitis, pneumonia, sinusitis or pericranial fistula or in patients with known risk factors such as myeloma or splenectomy To have seizures prior to arrive to the hospital or the in the study Pregnancy or breastfeeding To have conduction abnormalities in ECG History of allergy or intolerance to phenytoin Patients with meningitis as a complication of neurosurgical procedures Epileptic patients taking usually anticonvulsivants Refusal by the patient or family to participate and/or to sign the informed consent | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Post-lumbar Puncture Headache Backache All adult patients (>= 18 years old) referred at the Neurological Day Center to get a lumbar puncture Contraindication to get a lumbar puncture | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, Meningococcal Meningitis Meningococcal Infections Willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explain For the purpose of this study, a healthy volunteer is defined as healthy male or female, with no significant chronic conditions Age 18 to 50 years old Either gender. Abstinence or use of contraception during the eight weeks after vaccination will be required for non menopausal (< two years post-menopause) or non surgically sterile women Persons with antibody titer(s) of <2 µg/mL to serogroup(s) A, C, Y, or W-135 polysaccharides as measured by ELISA Age less than 18 years or over 50 years History of Guillain-Barré syndrome (GBS) Pregnancy or lactation History of meningococcal meningitis History of invasive (clinical or laboratory diagnosis) meningococcal disease History of meningococcal meningitis vaccination Screening laboratory abnormalities (in the opinion of the Investigator) that would raise safety concerns for participation in the study Use of immunosuppressive drugs within 30 days prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents History of anaphylactic shock, asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination History of severe allergic disorders or autoimmune connective tissue disorders, including rheumatoid arthritis. A high sensitivity C-Reactive Protein (CRP) test at screening will be used as part of the assessment of autoimmune disorders by the Principal Investigator | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, Post Dural Puncture Headache 50 years old Undergoing diagnostic LP for any indication for the first time COPD Any known chronic pulmonary disease Acute febrile illness Persistent headaches Known sensitivity to Benzodiazepines Current or prior substance abuse disorder Cognitive decline | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-30.0, Schistosomiasis Bilharziasis Urinary Schistosomiasis All subjects had to meet the study within 21 days prior to treatment Caucasian volunteers No smoker biological parameters (haematological, biochemical, renal and hepatic) in normal range Health Insurance sign inform consent inflammatory or immunological pathology such as atopic diseases, evidence of inflammation or acute infection (including positive serology to viral hepatitis B and C or HIV) any immunological deficiency any clinically relevant alcohol or drug use (cannabis, opiates, cocaine, amphetamines, benzodiazepines, nicotine, barbiturates, meprobamate or antidepressant drugs according to urine drug and metabolites screen) current immunosuppressor treatment any other medication use within 2 weeks before the study any vaccination within the last 6 months no antibodies against Sh28GST protein | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.25-16.0, Meningitis Age > 3 months and < 16 years Bacterial meningitis Written parental (or appropriate legal representative) informed consent prior to study Gram-negative bacteria in the CSF Creatinine clearance < 80ml/min/1.73m2 Creatinine phosphokinase level > 2x upper age related norm Known allergy or hypersensitivity to daptomycin Known clinical significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, hematologic, autoimmune disease, or primary immunodeficiency Height and weight below 3rd or above 95th percentile History of, or current muscular disease Underlying neurological disease with disruption of blood brain barrier Epilepsy Muscular weakness, history of peripheral neuropathy, or Guillain-Barré syndrome | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.167-15.0, Bacterial Meningitis The study entry is assessed for all children at age 2 months years who present at these centers with the symptoms and signs suggestive of BM, and to whom lumbar puncture is performed All patients whose cerebrospinal fluid (CSF) turns out to be cloudy, positive by Gram staining or latex agglutination, or shows at least 50 leukocytes per mm3, will be enrolled in the study Participants Trauma, or relevant underlying illness such as intracranial shunt, previous neurological abnormality (cerebral palsy, Down's syndrome, meningitis) Previous hearing impairment (if known) Immunosuppression, except HIV infection More than one parenteral dose of a pretreatment antimicrobial. Children with oral antimicrobials are included, this information being marked in the sheet Active tuberculosis (if tuberculotic meningitis is diagnosed during trial, it will be included in intention-to-treat (ITT) analysis) Known hepatic disease | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-0.247, Meningitis Informed consent form signed by the parents/carers Chronological age below 90 days inclusive The presence of clinical signs consistent with BM (hyperthermia or hypothermia or temperature instability PLUS 1 or more neurological findings among coma, seizures, neck stiffness, apnoea, bulging fontanelle) OR CSF pleocytosis (≥ 20 cells/mm3) OR a positive Gram stain of CSF Presence of a CSF device Proven viral or fungal meningitis Severe congenital malformations if the infant is not to expect to survive for more than 3 months Other situations where the treating physician considers a different empiric antibiotic regimen necessary Known intolerance or contraindication to the study medication Participation in any other clinical study of an investigational medicinal product Renal failure and requirement of haemofiltration or peritoneal dialysis Meningitis with an organism known to be resistant to meropenem | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-65.0, Acute Migraine Willing and able to provide written informed consent prior to participation in the clinical investigation Male or female aged between 18 and 65 years Diagnosed as suffering from migraine with or without aura according to IHS classification (ICHD-II) Reported history of 2 to 6 migraine episodes per month during previous 3 months, confirmed during a prospective baseline period of one month Reported history of no less than 50% of migraine episodes involving moderate or severe pain intensity, confirmed during a prospective baseline period of one month Reported history of at least 48 hours of freedom from headache between migraine attacks, confirmed during a prospective baseline period of one month Reported history of the majority of untreated migraine attack durations lasting 8 hours or more Onset of migraine headache occured before age 50 Reported history of migraine for more than one year Able and willing to maintain current preventive headache medication regimen(s) (no change in type, frequency or dose) from baseline screening visit to 2 weeks post-treatment Reported history of 15 or more headache days per month (i.e. headaches of any kind), confirmed during a prospective baseline period of one month Reported frequency of non-migraine headaches exceeding 6 days per month, confirmed during a prospective baseline period of one month Unable to distinguish between migraine headaches and other headache types at the onset of a migraine attack Treatment with Botox received within 6 months of the screening visit, or between the screening and treatment visit Previously treated with an implantable stimulator or any implantable devices in the head and/or neck Diagnosed as having a pronounced anterior septal deviation History of sinus surgery, transphenoidal surgery for pituitary or other lesions or CSF rhinorrhea Fitted with a pacemaker /defibrillator Previously treated with radiation to the face Ongoing bacterial infection in the nasal cavity | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Streptococcus Pneumoniae Neisseria Meningitidis Haemophilus Influenzae Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol Written informed consent obtained from the subject/from the parent(s)/LAR of the subject A male or female subject who visits the hospital with suspected bacterial meningitis CSF sample taken as part of routine practice Child in care | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Meningitis, Bacterial Positive CSF culture and/or positive soluble antigens in CSF with or without a cell reaction Positive PCR in CSF Purpura fulminant (with or without positive CSF culture) Positive PCR in blood and/or positive blood culture AND CSF cell reaction Age less than 18 years old Refusal to participate | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Pneumonia, Bacterial Pneumonia, Viral Meningitis, Bacterial Pneumonia surveillance resident of Tône sanitary district requiring hospitalisation for at least one night for clinical pneumonia syndrome hospitalised in a study site during the study period absence of informed consent by patient or legal tutor Meningitis surveillance resident of Tône sanitary district presenting clinical signs of acute bacterial meningitis hospitalised in a study site during the study period absence of informed consent by patient or legal tutor | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Stress Disorders, Post-Traumatic Myocardial Infarction Age over 18 years STEMI (ST-elevated myocardial infarction) or non-STEMI Stable circulatory condition Numeric Rating Scale (NRS) (0-10): a score of at least 5 for "pain (during MI)" plus a score of at least 5 for "fear of dying (until admission to the CCU)" and/or "making sorrows and feeling helpless (when being told about having MI)" Written informed consent Participating in any other randomized-controlled trial run by the Cardiology Department of the University Hospital of Bern Emergency coronary artery bypass graft surgery Comorbid serious disease likely to cause death within 1 year Current clinically severe depression Not fully oriented to the situation, person, and place Cognitive impairment according to an adapted short version of the Mini-Mental State Examination Insufficient knowledge of German language in reading and understanding Affirmation of suicidal ideation in the last two weeks | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 30.0-70.0, Posttraumatic Stress Disorder PTSD as determined by the Structural Clinical Interview for DSMIV (SCID) interview of PTSD and the Clinical Administered PTSD Scale (CAPS) Veteran with history of active duty service and currently discharged from active duty service Free of psychotropic medication for four weeks before the study History of shrapnel or other foreign bodies which would preclude MRI scanning Meningitis Traumatic brain injury Neurological disorder or organic mental disorder History of loss of consciousness Current or lifetime history of alcohol abuse or substance abuse or dependence base on the SCID Current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia based on the SCID History of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness Evidence of a major or neurological illness on physical examination or as a result of laboratory studies positive urine toxicology screen | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-65.0, Tuberculous Meningitis Age 18 years or older Probable/possible tuberculosis meningitis using uniform case definition Agree to participate in the study Patient with antituberculosis treatment within last 2 weeks Increase liver function >5x upper limit of normal Pregnancy | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 8.0-17.0, Traumatic Brain Injury Brain Concussion Children aged between 8 and 17 years old. This will be limited to this small spectrum of age to insure better homogeneity in the evaluation of the participants and streamlining of outcome measures. Also, this is the age group for which our measurement tool has been validated Occurrence of a mTBI as defined by the presence of a head trauma, a Glasgow coma scale of 13 to 15 and at least one of the three following criteria4 Any period of loss of consciousness Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of the accident (eg, feeling dazed, disoriented) And the absence of the following Post-traumatic amnesia greater than 24 hours Glasgow Coma Scale < 13, 30 minutes post accident The trauma occurred in the preceding 24 hours Inability to obtain a proper written informed consent (language barrier, absence of a parental authority, developmental delay, intoxication, patient too confuse to consent according to the treating physician) Known allergic reaction or intolerance to ondansetron. 3. Known rhythm or cardiac problem, or history of sudden death in the proximal family 4. Patients who are taking a medication which could increase the QT interval. 5. Patients who received ondansetron in the previous 24 hours 6. Any abnormality on radiological studies, including any bleeding in the brain or skull fracture Multi-system injuries with treatment requiring admission to hospital or procedural sedation in the ED | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 7.0-15.0, Perennial Allergic Rhinitis Patients aged between 7 and 15 years Patients who have received a diagnosis of perennial allergic rhinitis according to the diagnostic Patients with a mean rhinorrhea score and a mean sneezing score of at least 2 on the basis of symptoms recorded in the nasal allergy diary during the observation period etc Patients with vasomotor rhinitis or eosinophilic rhinitis Patients who have concurrent nasal disease that may affect the efficacy of TAU-284 Patients with a history of any of the nasal surgical procedures Patients who have a positive result for pollen antigens which are dispersed during the study period Patients who have a positive result for dog dander or cat dander antigen and have a chance to touch dogs or cats Patients with current or previous history of drug allergy Patients who concurrently have renal function abnormalities that may cause safety problems etc | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-55.0, Meningococcal Meningitis Meningococcal Infections (IC) Participant is willing and able to give informed consent and comply with all aspects of the evaluation after the nature of the study is explained Male or female, aged 18 to 55 years old In general good health with no significant chronic or acute conditions that would interfere with immune response or expected Adverse Event (AE) evaluation in the opinion of the investigator as determined by Medical history and/or History-directed physical examination Abstinence or use of effective contraception by the participants or their partners during the trial and continuing for four weeks after vaccination will be required for males or female participants of child bearing potential Able (in the opinion of the investigator) to comply with all study requirements (EC) Unwilling or unable to understand study requirements and give written informed consent for the study Prisoners History of Guillain-Barré syndrome (GBS) Pregnancy (confirmed by positive pregnancy test) or lactation Previous diagnosis of laboratory confirmed meningococcal disease Previous meningococcal meningitis vaccination in the last five years Laboratory abnormalities that are considered Grade 2 or higher (based on AE, ranges as described in the protocol appendix) that in the opinion of the Investigator would raise safety concerns for participation in the study or interfere with evaluation of study objectives, or abnormalities >2 times the Upper Limit of Normal range (ULN) Known or suspected autoimmune or connective tissue disorders, including rheumatoid arthritis and congenital or acquired immunodeficiency. Does not mild to moderate seasonal/perennial allergies treated with over the counter antihistamines Use of systemic immunosuppressive drugs or therapy within 6 months prior to study enrollment, not including topical or inhaled steroids/cytotoxic agents. Includes anti-cancer chemotherapy, radiation, and long term systemic corticosteroid therapy. History of anaphylactic shock, severe asthma, urticaria, or other allergic or hypersensitivity reactions following vaccination or known hypersensitivity to any vaccine component | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 50.0-999.0, Low Trauma Non Vertebral Fracture Patients of more than 50 years old Low trauma non vertebral fracture Ambulatory patient Direct access to mobile phone (or access with the help of a close person) and ability to communicate via SMS Patient who doesn't oppose to his participation in the study Affiliation to the social security Patients hospitalized for the fracture in the orthopaedics department because these more severe patients have a systematic screening and management of osteoporosis Fractures whose location is not suggestive of osteoporotic fracture (cervical spine, skull, hands, fingers, toes) Pathological fractures (cancer or myeloma) Traumatic fractures Severe alterations of cognitive functions Resident subjects except Paris and the surrounding area | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 12.0-999.0, Perennial Allergic Rhinitis Diagnosed with perennial allergic rhinitis Outpatient Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) Coexisting infections or systemic mycosis for which there are no effective antibiotics Asthma complication under treatment Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed Vasomotor rhinitis or eosinophilic rhinitis Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug History of hypersensitivity to antihistamines or study drug Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Nasal Septum Deviation Headache All patients older than 18 years whom underwent sinuses or facial tomography Patients with clinical history of trauma | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-85.0, Primary Headache 85 years old Benign headache Physician intends to treat headache pain in the ED with either droperidol, prochlorperazine, or a parenteral narcotic Unable to provide informed consent Headache due to trauma, subarachnoid hemorrhage, meningitis, intracerebral bleed, cranial tumor, sinusitis, dental pathology, temporomandibular joint dysfunction, glaucoma, or systemic infection Known renal impairment Known hepatic impairment A history of coronary artery disease, peripheral vascular disease, or cerebrovascular disease Perforated ear drum Pregnant | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Inner Ear Malformations Must have an inner ear malformation Must meet the for cochlear implantation Prior cochlear implantation surgery | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Traumatic Brain Injury Severe or moderate brain trauma subjects with need of ICU care Glasgow Coma Score (GCS) ≤ 8 after the primary stabilization has been performed in the field (= patient not hypoxic or hypotensive) and at least 30 min interval from the moment of injury GCS 9 and the patient is deteriorating The patient has GCS ≤ 13 and has other injuries, which require interventions for hemodynamic or ventilatory incidents The patient is in urgent need of neurosurgery (craniotomy, impression skull fracture, severe haemorrhagic contusion, or ICP measurement) Moderate or mild brain trauma not in need of ICU care All other patients who fulfil the diagnostic for an acute TBI but without any defined below Age < 18 years at study entry Blast-induced TBI Perforating or penetrating mechanism of TBI Unable to live independently because of a brain disease (= e.g. people with moderate dementia, Down's syndrome, cerebral palsy etc.) or other medical cause before the injury TBIs or suspected TBIs not needing cranial CT imaging (excludes the mildest TBIs with negligible risk for incomplete recovery) for control subjects Age ≥ 18 years at study entry Acute orthopaedic non-trivial trauma that needs either surgery or conservative measures and clinical follow-up (including mere superficial soft tissue injuries) for control subjects | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-18.0, Head Injury Parents and their child, seeking care for a child who Is < 18 years of age Had blunt trauma above the eyebrows (not isolated to face or eyes) Is positive for at least 1 of the clinical prediction rule predictors described below Predictors for children < 2 years of age Severe mechanism (PECARN definition)* Loss of consciousness > 5 seconds Acting abnormally per parent Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition) Presence of occipital, temporal or parietal scalp hematoma Palpable skull fracture or unclear if skull fracture predictors for children 2-18 years of age Severe mechanism (PECARN definition)* Any loss of consciousness Any vomiting since the injury Severe headache in ED Initial ED GCS < 15 by attending (or CT decision-maker) Other signs of altered mental status (PECARN definition)** Any sign of basilar skull fracture Clinicians attending physicians and fellows or midlevel providers caring for children with head trauma Parents of children with GCS scores < 15 Evidence of penetrating trauma, signs of basilar skull fracture, or depressed skull fracture on physical examination Brain tumors Ventricular shunts Bleeding disorder Pre-existing neurological disorders complicating assessment Neuroimaging at an outside hospital before transfer Signs of altered mental status (agitation, somnolence, repetitive questioning, or slow response to verbal communication) Syncope or seizure disorder preceded (led to) head trauma or seizure post head trauma | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 5.0-999.0, Concussion Stress Disorders, Post-Traumatic All patients will be recruited from the Bellevue Hospital Emergency Services (Emergency Department and Trauma Bay) or from among inpatient populations at Bellevue Hospital. They will need to be consentable and able/willing to participate and meet for distribution into one of the three subject populations (structural TBI, non-structural TBI, injured/non-TBI) described here mild to moderate structural traumatic brain injury (TBI) as evidenced by CT scan demonstrating the presence of hemorrhage (subdural, epidural, subarachnoid or intraparenchymal), brain contusion, or skull fracture non-structural TBI(concussion), meaning no signs of structural injury on imaging; however, they complain of usual brain injury symptoms such as headache, dizziness, cognitive impairments, etc., A subject with a traumatically induced physiological disruption of brain function, manifested by >1 of the following Any period of loss of consciousness (LOC) Any loss of memory for events immediately before or after the accident Any alteration in mental state at the time of accident (i.e. feeling dazed, disoriented, or confused) Focal neurological deficit(s) that may or may not be transient, but where the severity of the injury does not exceed the following Loss of consciousness of approximately 30 minutes or less After 30 minutes, an initial Glasgow Coma Scale (GCS) of 13-15 Posttraumatic amnesia (PTA) not greater than 24 hours Subjects that receive minor penetrating trauma insufficiently traumatizing to result in sufficient sequelae will be excluded Subjects suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability will also be excluded Particularly for the purposes of eye tracking all subjects that are blind (no light perception), are missing eyes, do not open eyes will be excluded from the research It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant Any physical or mental injury or baseline disability rendering task completion difficult will be excluded, also inability to participate in longtitudinal care, or obvious intoxication or blood alcohol level greater than 0.2 Pregnant individuals and prisoners will also be excluded from the study | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-55.0, Cephalalgia Complain about cephalalgia Age 28 to 55 years Fever > 38,0 °C History of breath disease, long term use of oxygen therapy, chronic obstructive pulmonary disease, dyspnéa History of cranial traumatism, heart attack, cerebrovascular accident <3 month Inability to read or understand french Pregnancy | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 2.0-5.0, Cold for patients with common cold Male or female at least 2 but not older than 5 years of age at screening Have a diagnosis of a common cold defined as presence of acute onset of rhinorrhea (within 48 hours of screening visit) and at least 1 of the following Presence of swollen nasal membranes characteristic of a common cold on examination at screening Presence of fever up to 102°F (oral or equivalent) within 48 hours of visit (may be taken at home/away from the clinic) or at time of screening Capability of parent/legal guardian to read and understand the informed consent, record trial diary information, administer trial drug and read and understand trial assessment questionnaire for patients with allergies Male or female at least 2 but not older than 5 year of age Have a diagnosis of seasonal or perennial allergic rhinitis defined as having both of the following Positive skin or Radioallergosorbent test (RAST) test to a relevant allergen within 12 months of screening or at the screening visit. For the purpose of this trial a positive skin test is defined as wheal diameter that is at least 3 mm greater than the negative control for both common cold and allergy Significant cardiovascular, renal, hepatic, endocrine, metabolic, neurologic or other systemic disease. A significant disease was defined as one which, in the opinion of the Investigator, either put the patient at risk because of participation in the trial or influenced the results of the trial or the patient's ability to participate in the trial Presence of rales or rhonchi suggestive of a lower respiratory tract infection An oral (or equivalent) temperature higher than 102°F Presence of otitis media Be initiating or advancing immunotherapy regimen during the course of this trial. Patients receiving a maintenance dose of immunotherapy are eligible Known intolerance to anticholinergics of hypersensitivity to benzalkonium chloride Excluded medications prior to Visit 1 and during the trial included 24 hours before Over-the-counter decongestants or nasal/ocular cromolyn | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-50.0, Healthy Volunteers Male or female of any race 50 years old, inclusive Females: negative urine pregnancy test on the day of study participation (prior to exposure to hypoxia) Completed within the last year: physical exam by a licensed physician, physician assistant (PA), or advanced practice nurse; including a 12 lead ECG, a medical history, and blood test (complete blood count and sickle cell trait/disease screening) Meets specific demographic requirements for the monitoring device under study Willing and able to provide written informed consent Able to participate for the duration of the evaluation A room-air baseline % modulation < 1.5% on all four fingers on the test hand Under 18 years or over 50 years of age Pregnant and/or lactating women Hypertension: on three consecutive readings, systolic pressure greater than 145 mm Hg or diastolic pressure greater than 90 mm Hg Ventricular premature complexes (VPC's) that are symptomatic or occur at a rate of more than four per minute History of seizures (except childhood febrile seizures) or epilepsy History of unexplained syncope Daily or more frequent use of anxiolytic drugs (benzodiazepines) for treatment of anxiety disorder Recent history of frequent migraine headaches: average of two or more per month over the last year Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.) | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Spontaneous Intracranial Hypotension years or more No contraindication for BPE Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest Headache from 5 to 28 days Normal or evidence of low CSF on MRI Signed informed consent Known dural leak in the previous 2 months Abnormal MRI First BPE for SIH The patient has participated in another clinical trial than can interact with the evaluation Contraindication of Trendelenburg position | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 55.0-85.0, Probable Alzheimer Disease (AD) Parkinson Disease (PK) Neurological Disease Without Cognitive Degradation Brain Trauma Acute Hydrocephaly Reports written consent, informed and signed by the patient and a trusted person Subject member or beneficiary of a social security system Specific for group 1 and 2B Age between 55 and 85 years old for patients Subject with AD or other neurodegenerative disease (frontotemporal dementia, dementia with Lewy bodies, Parkinson disease) Subjects with chronic adult hydrocephalus (HCA) requiring depletion lumbar puncture (PL) Specific for group 2A Adult patient requiring neurosurgery with CSF shunt (subject with brain trauma, acute hydrocephaly) and favorable evolution that allows removal of the shunt Patient deprived of liberty by judicial or administrative decision Major protected by law Pregnancy, women of childbearing age with risk of pregnancy, or breast-feeding Presence of a transmissible viral disease (HlV, hepatitis B and C) Patient included in a clinical trial lnadequate cardiac, hepatic or severe renal disfunction Disease amino acid metabolism (Leucinose..) Information clinical and para-clinical insufficient or unavailable Patient deprived of liberty by judicial or administrative decision Major protected by law | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-80.0, Pituitary Adenoma Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery Adults (age 18-80 years) Medically stable for surgery Reasonable expectation that patient will complete study and be available for follow-up assessments Prisoners Pregnant women Patients with suspected functioning pituitary adenoma Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR) Pituitary apoplexy | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-999.0, Brain Injuries Skull Fractures Severe traumatic brain injury, GCS 8 or less and/or Craniofacial fracture Died before admitted to hospital | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Cerebrospinal Fluid Leak Subjects ≥18 years of age undergoing craniotomy/craniectomy for pathological processes in the supratentorial region or posterior fossa Subjects or legally authorized representatives must be willing to participate in the study and provide written informed consent Surgical wound classification Class I The cuff of native dura along the craniotomy edge on each side is adequate, based on surgeon's judgment, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product Presence of intra-operative cerebrospinal fluid (CSF) leakage following primary dural closure or after Valsalva maneuver Subjects with a dural lesion from a recent surgery that still has the potential for CSF leakage Chemotherapy scheduled within 7 days following surgery Radiation therapy to the head scheduled within 7 days following surgery A previous craniotomy/craniectomy within 6 months prior to the study surgery Known hypersensitivity to the components of the investigational product Subjects with a known allergy to FD&C Blue #1 dye Subjects with an infection present at the surgical site Subjects with an infection indicated by any one of the following: clinical diagnosis of infection, fever, positive urine culture, positive blood culture, positive chest X-ray Female subjects of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period Female subjects who are nursing | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.083-18.0, Bacterial Meningitis Probable bacterial meningitis patients: Clinical manifestation (Any person with sudden onset of fever (> 38.5 °C rectal or 38.0 °C axillary) and one of the following signs: neck stiffness, altered consciousness or other meningeal sign) with cerebrospinal fluid examination showing at least one of the following A. turbid appearance; B.leukocytosis (> 100 cells/mm3); C.leukocytosis (10-100 cells/ mm3) AND either an elevated protein (> 100 mg/dl) or decreased glucose (< 40 mg/dl) Confirmed bacterial meningitis patients: A case that is laboratory-confirmed by growing (i.e. culturing) or identifying (i.e. by Gram stain or antigen detection methods) a bacterial pathogen (Hib, pneumococcus or meningococcus) in the cerebrospinal fluid or from the blood in a child with a clinical syndrome consistent with bacterial meningitis Congenital immunodeficiency patients HIV patients Patients with corticosteroid treatment for long time Patients with disorders in adrenal gland and pituitary gland and hypothalamus Patients with tuberculosis | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Brain Injuries Patients treated in the ICU with the diagnose of traumatic or nontraumatic brain damage, with a more than 24-hour stay Patients admitted less than 24 hour | 2 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 0.0-0.083, Neonatal Sepsis Neonatal Infection Neonatal Meningitis This study aims to all neonates presenting here and at the high and medium care facilities with clinical signs of infection, sepsis or meningitis (age: 0-1 month) that require infection work up (i.e., laboratory testing and culturing) Baseline controls: uncomplicated jaunice, no other signs of infection Clinical signs of infection: tachypnea, dyspnea, apnea, grunting, tachycardia, bradycardia, hypotension, poor perfusion, vomitus, abdominal distension, constipation, poor feeding, lethargy, irritability, convulsions, temperature instability, pale, yellow, bleak, petechiae, bruising, bleeding Extreme prematurity: gestational below 32 weeks of gestational age Extreme dysmaturity: birthweight below 1500 grams Maternal HIV or malignancy | 0 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-75.0, Acute Traumatic Spinal Cord Injury Aged 18-75 years inclusive Diagnosis of acute SCI Injury is less than 24 hours old Impairment Scale Grade "A," "B" or "C" based upon first evaluation after arrival to the hospital Neurological level of injury between C4-C8 based upon first evaluation after arrival to the hospital Women of childbearing potential must have a negative serum β-hCG pregnancy test or a negative urine pregnancy test Patient is willing to participate in the study Informed consent document signed by patient or witnessed informed consent document No contraindications for study treatment(s) Able to cooperate in the completion of a standardized neurological examination by standards (includes patients who are on a ventilator) Injury arising from penetrating mechanism Significant concomitant head injury defined by a Glasgow Coma Scale (GCS) score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator) Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with hallucinations and/or delusions or schizophrenia) Prior history of SCI Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator Is a prisoner Participation in another clinical trial within the past 30 days Acquired immune deficiency syndrome (AIDS) or AIDS-related complex Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study | 1 |
A 44-year-old man was recently in an automobile accident where he sustained a skull fracture. In the emergency room, he noted clear fluid dripping from his nose. The following day he started complaining of severe headache and fever. Nuchal rigidity was found on physical examination. | eligible ages (years): 18.0-999.0, Meningitis Meningococcal Meningitis Meningococcal Infections Aged ≥ 18 years on the day of Received booster dose of Menactra vaccine in trial MTA77 Informed consent form has been signed and dated Able to attend the scheduled visit and to comply with all trial procedures Participation at the time of trial enrollment (or in the 4 weeks preceding trial enrollment) in another clinical trial investigating a vaccine, drug, medical device, or medical procedure Receipt of any meningococcal vaccine, including serogroup B meningococcal vaccine, after receipt of the booster dose of Menactra vaccine administered in trial MTA77 Receipt of immune globulins, blood or blood-derived products in the past 3 months Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) History of meningococcal infection, confirmed either clinically, serologically, or microbiologically Bleeding disorder, thrombocytopenia, or receipt of anticoagulants contraindicating venipuncture at the discretion of the Investigator Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily Current alcohol abuse or drug addiction Any illness that, in the opinion of the Investigator, might interfere with trial conduct or trial results Receipt of oral or injectable antibiotic therapy within 72 hours prior to the blood draw. (A prospective subject should not be included in the trial until 72 hours has passed.) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-999.0, Deglutition Disorder Motor Neuron Disease Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any other NIH institute protocol can be included for study as well as patients who are admitted specifically for this protocol Those patients at risk for oropharyngeal dysfunction will be screened initially by completing a self-assessment swallowing questionnaire, and by an interview with staff and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia and oral motor impairment on the screening assessment will be considered for the protocol Difficulty swallowing food or pills Changed swallowing ability Coughing or choking when eating Shortness of breath during swallowing Food backing up into the mouth or nasal passage Fever or voice changes after swallowing Pain when swallowing Unexplained loss of weight Patients who are severely demented or severely compromised will be excluded if they do not have sufficient cognitive ability to follow directions Patients who are non-ambulatory will be excluded if they can not be braced or supported within the fluoroscopy unit Highly agitated individuals will also be excluded if they are unable to remain confined in the equipment Infants and children under age 3 will be excluded due to radiation risk on the developing visual system | 2 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 20.0-80.0, Phonation Disorder Spastic Dysphonia Voice Disorder Normal Volunteers Normal volunteers between the ages of 20 and 80 years of age will be selected after a screening examination Subjects will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech and hearing problems as determined by medical history and examination by an otolaryngologist None of the subjects included for study will have a reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm Normal Volunteers Any patient with a history of airway obstruction will be excluded from the study No smokers or tobacco users will be included in the study Subjects with a history of a psychiatric disorder, under the care of a psychiatrist, or on medications for treatment of a psychiatric disorder will be excluded from 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 Any individual with: 1) an implant or surgical clip implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular implant, aneurysm clip, artificial heart valve, insulin pump, orthopedic pins or prosthesis: 2) a foreign body metal shavings, shrapnel, orthodontic braces, tattoos or permanent eye liner; and/or, 3) any other implanted device or foreign body not listed above that is possibly ferromagnetic will also be excluded from study seven because of contraindications for magnetic resonance imaging Patients with Spasmodic Dysphonia Symptoms present during speech and not apparent at rest Symptoms less evident during whisper, singing or falsetto | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 20.0-70.0, Voice Disorders The for normal volunteers are normal vocal function and average health as determined by the staff otolaryngologist. Normal vocal function refers to normal voice quality, a negative history for voice or laryngeal disorders. Persons with significant pulmonary, neurological and psychiatric function will not be recruited. The primary for the voice disordered groups are a current diagnosis of spasmodic dysphonia (abductor or adductor type), muscular tension dysphonia or voice tremor. These persons will not have pulmonary, neurological or psychiatric disorders or criteria for Patients with Spasmodic Dysphonia Intermittent strained hoarseness, uncontrolled voice breaks or changes in pitch are present during vowels, liquids (r & l) and semi-vowels (w & y), during speech for adductor SD or prolonged voiceless consonants producing breathy breaks for abductor SD Less prominent symptoms during whisper, singing or falsetto Normal voice and vocal fold movement for protective and emotional laryngeal function, such as cough, laugh or cry A diagnosis of adductor or adductor spasmodic dysphonia based on voice testing and fiberoptic nasolaryngoscopy by a board certified otolaryngologist and Speech-Language Pathologist during the initial interview of other laryngeal pathologies based on a fiberoptic nasolaryngoscopic examination conducted during the initial interview by the staff otolaryngologist for Patients with Muscular Tension Dysphonia Increased phonatory muscle tension in the paralaryngeal and suprahyoid muscles on palpation A consistent hypertonic laryngeal posture for phonation, such as either an anterior-posterior squeeze (pin-hole posture) or ventricular hyper adduction and an absence of SD or vocal tremor as determined by a Speech-Language Pathologist and the staff otolaryngologist Any individual with a history of one or more of the following contraindications will be excluded from the study Airway obstruction, smoking or tobacco use Pulmonary, or neurological disease Pregnancy as reported by the volunteer or a positive pregnancy result from a urine sample obtained on the day of testing Psychiatric disorder, under psychiatric care, or on medication for psychiatric disorders. Examples of psychiatric disorders to be excluded are: somatoform disorders, conversion disorders, major depression, schizophrenia or a bipolar disorder. A history of a previous episode of minor reactive depression would not a person from participation Speech or hearing problems as determined by medical history and examination by the otolaryngologist. A 30 dB HL hearing screening between 500 and 3000 Hz will be conducted if subjects report difficulty following spoken instructions or significant noise exposure A reduction in the range of vocal fold movement during non-speech tasks such as whistling suggesting either paralysis or paresis, joint abnormality or neoplasm as determined by videolaryngoscopic examination by the staff otolaryngologist Complete aphonia, a history of airway obstruction or structural abnormalities affect the larynx such as vocal fold nodules, polyps, carcinoma, cysts, contact ulcers, chronic laryngitis as determined by videolaryngoscopic examination by the staff otolaryngologist Individuals having any condition that would present unnecessary risk to them, e.g., claustrophobia Specific contraindications for magnetic resonance imaging i) Any implant or surgical clip | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-999.0, Auditory Perception Males and females of any race or ethnicity will be eligible to participate in this study Volunteers must be between the ages of 18 and 45 with normal hearing and voice function. Participants will be further selected for having a steady heart rate. A history of voice training is not required, but participants must be able to produce grossly independent voice F0 and amplitude changes Contraindications to participation pregnancy, cardiac pacemaker or auto defibrillator, artificial heart valve, neural pacemaker, surgical metal clips in the brain, eye, or on blood vessels, cochlear implants, ocular implants or foreign bodies such as metal shavings or splinters, insulin pump, implanted drug infusion device, shrapnel, bullet or shot wound, and tattooed makeup. Participants will be screened with the NMR Center Safety Screening Questionnaire which also includes items such as intraventricular shunts, transdermal medication patches, wire sutures, bone/joint pins, screws, nails, or plates, and body piercings. Given that surgical staples, orthopedic pins, orthodontic braces and dental implants are no longer considered absolute contraindications in MRI, Dr. Saxon or Dr. Kearney will approve or disapprove participation in the study based on their judgment of the MR compatibility of these items, using published guides including those referenced above Volunteers will be also excluded if they are found to be pregnant, report any tendency toward claustrophobia or are unable for any reason to lie still within an MR scanner | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.0-999.0, Healthy The Healthy volunteers will be without cardiac, pulmonary, neurological, otolaryngological, psychiatric or speech, swallowing and hearing problems as determined by medical history and examination by a physician History of Rheumatic fever, mitral valve prolapse, or cardiac arrhythmias as determined by medical history, physical and EKG. A physician will auscultate for cardiac murmurs prior to any study to volunteers who might be at risk for endocarditis. Subjects will have an EKG as part of the screening for participation in the study Pregnancy will women from participation because the study involves radiation exposure None of the Healthy volunteers will have a reduction in the range of vocal fold movement during the nasoendoscopy that might suggest laryngeal paralysis or paresis, joint abnormality or neoplasm Healthy Volunteers who have a cardiac demand pacemaker, dementia, exhibit non-stop vocalization, significant reflux due to use of a feeding tube, or drug toxicity will not be included for VitalStim, as these are contraindications to use of the device | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 6.0-21.0, Cerebral Palsy Drooling diagnosis of cerebral palsy severe drooling aged 6-21 yrs subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form age below 6 yrs or above 21 yrs known allergy or sensitivity to the study medication or its component diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function subjects who have prior surgery of the submandibular gland subjects who are receiving medication that affect drooling such as anticholinergic drug inability to give informed consent | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.5-13.0, Tonsillitis Pharyngitis Age 6 months to less than 13 years of age (<13) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection throat swab test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Tonsil and/or pharyngeal erythema and/or exudate Cervical adenopathy Uvular edema Fever Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Females of childbearing potential (ie, have reached menarche) Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L]), or hypomagnesemia or bradycardia (<50 bpm) Myasthenia gravis Known impaired renal function, as shown by creatinine clearance ≤25 mL/min The subject | 1 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 13.0-999.0, Tonsillitis Pharyngitis Age equal to or over 13 years For female subjects, the following conditions are to be met Subject is premenarchal or surgically incapable of bearing children Subject is of childbearing potential and all of the following conditions are met Have normal menstrual flow within 1 month before study entry Have negative pregnancy test (urine pregnancy test sensitive to at least 50 mU/mL, and Must agree to use an accepted method of contraception throughout the study (if sexually active) Clinical diagnosis of acute tonsillitis/pharyngitis caused by Streptococcus pyogenes based on A positive result from a rapid detection test for Group A streptococcal antigen and submission of a throat swab specimen for bacterial culture, identification, and antibiotic-susceptibility testing; and A sore and scratchy throat and/or pain on swallowing (odynophagia) together with at least 2 of the following clinical signs Symptoms that collectively suggest nonstreptococcal T/P (eg, laryngitis, coryza, conjunctivitis, diarrhea, cough) History of positive throat culture for Streptococcus pyogenes in the absence of clinical signs and symptoms of T/P Infection of the deep tissues of the upper respiratory tract (eg, epiglottitis, retropharyngeal or buccal cellulitis, or abscess of the retropharynx, tonsil, or peritonsillar area) or of the suprapharyngeal respiratory tract and its connecting structures (eg, sinusitis, otitis media, or orbital/periorbital cellulitis) History of rheumatic heart disease Known congenital prolonged QT syndrome Known or suspected uncorrected hypokalemia (≤3 mmol/L [mEq/L) or hypomagnesemia or bradycardia (<50 bpm) Known impaired renal function, as shown by creatinine clearance ≤25 mL/min Myasthenia gravis History of hypersensitivity or intolerance to macrolides, penicillins, or cephalosporins Previous enrollment in this study or previous treatment with telithromycin | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.115-0.231, Pneumococcal Infections Male or female between, and including, 6-12 weeks (42 to 90 days) of age at the time of the first vaccination Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol Written informed consent obtained from the parent or guardian of the subject Free of obvious health problems as established by medical history and clinical examination before entering into the study Born after a gestation period between 36 and 42 weeks Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3 Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, and/or S. pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, and Haemophilus influenzae type b diseases History of allergic disease or reactions likely to be exacerbated by any component of the vaccines History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease Acute disease at the time of enrolment Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical A family history of congenital or hereditary immunodeficiency | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 1.0-18.0, Sleep Apnea, Obstructive Respiration Disorders year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 0.167-4.917, Severe Pneumonia Age: 2 to 59 months Sex: Both boys and girls Severe pneumonia according to WHO (Severe pneumonia is defined as cough or difficult breathing with lower chest wall in drawing with or without fast breathing which is defined as the respiratory rate ≥ 50 breaths per minute for children aged 2-11 months and ≥ 40 breaths per minute for children aged 12-59 months) Attend the Radda Clinic and ICHSH between 8:00 am to 4:00 pm (Sunday through Saturday) Written informed consent by respective parents/guardians Very severe and non-severe pneumonia Nosocomial pneumonia History of taking antibiotics for pneumonia within 48 hour prior to enrollment Chronic illnesses like tuberculosis, cystic fibrosis Congenital deformities/anomalies e.g. Down's Syndrome, congenital heart disease Immunodeficiency Trauma/burn Bronchiolitis Bronchial asthma Lives far away from the Radda Clinic and ICHSH (outside 5 km radius from the respective study site) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 3.0-18.0, Cerebral Palsy Neurological Conditions Mental Retardation Sialorrhea To be included in this study, patients must meet the following Male or female, weighing at least 13 kilograms (27 pounds), aged 3 through 18 years Diagnosis of cerebral palsy and/or mental retardation or any other neurologic impairment or condition (cognitively capable and cognitively impaired patients may be enrolled) Chronic drooling in the absence of treatment to the extent that the chin or clothing becomes wet on most days by confirming the Modified Teacher's Drooling Scale score ≥ 5 Must be living in a situation where reliable parents/caregivers are willing and capable of administering medications, as determined by the investigator Written informed consent signed by the parent or legally acceptable representative Written assent signed by the age-appropriate patient if mentally capable, as determined by the investigator, and required by the site's Institutional Review Board If female of childbearing potential, the patient must have a negative pregnancy test at screening and Visit 2 If female of childbearing potential and sexually active, she must use a medically acceptable form of contraception Patients are excluded from this study if they meet any of the following Patients who used glycopyrrolate within approximately 24 hours prior to the start of the baseline period, which began on Day -2 Patients who used prohibited medications within 5 plasma half-lives of the medication prior to the start of the baseline period Patients injected with intrasalivary gland botulinum toxin within 10 months prior to the start of the baseline period Patients using intraoral devices or prosthetics for the treatment of drooling within 1 week prior to the start of the baseline period Patients receiving acupuncture for the treatment of drooling or who have received acupuncture for the treatment of drooling within 3 months prior to the start of the baseline period Patients who have medical conditions contraindicating anticholinergic therapy including gastrointestinal reflux, narrow-angle glaucoma, obstructive uropathy, obstructive disease of the gastrointestinal tract (i.e., delayed gastric emptying, pyloroduodenal stenosis, etc.), paralytic ileus, intestinal atony, vesicoureteral reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant electrocardiogram abnormalities, as determined by the investigator Patients who have a known contraindication to the study medication, including allergy to the study medication or any of its components Patients who have poorly controlled seizures defined as daily seizures Patients who have a history of obstructive disease of the gastrointestinal tract (i.e., intestinal obstruction) | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-85.0, Drooling Parkinsons' Disease patients with Sialorrhea for at least 3 months Patients with non-idiopathic PD parkinsonism Patients previously exposed to botulinum toxins Patients with a history of aspiration pneumonia, moderate/severe choking and/or moderate/severe dysphagia Patients with prior salivary gland surgery | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 2.0-4.917, Healthy Healthy Age: born within the same calendar quarter as the reference FluMist vaccinee Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-85.0, Intrathoracic Malignancies Unilateral Vocal Cord Paralysis Patients with UVCP undergoing type I thyroplasty or vocal fold augmentation for rehabilitation of speech and swallowing for the healthy subjects From age 18-85 for the UVCP patients includes the following History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia) History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease History of previous moderate to severe traumatic brain injury History of significant cardiovascular, gastrointestinal or renal disease (e.g. myocardial infarction within the previous 12 months, significant vaso-occlusive disease, severe or advanced asthma, or renal compromise) History of achalasia History of dysphagia, odynophagia, or aphasia unrelated to present illness History of significant claustrophobic reactions Standard contraindications to MR examinations (e.g. implanted stimulators, pregnancy) for the healthy subjects includes the following | 0 |
A 5-year-old boy presents to the emergency department with complaints of progressively worsening dysphagia, drooling, fever and vocal changes. He is toxic-appearing, and leans forward while sitting on his mother's lap. He is drooling and speaks with a muffled "hot potato" voice. The parents deny the possibility of foreign body ingestion or trauma, and they report that they are delaying some of his vaccines. | eligible ages (years): 18.0-80.0, Paralysis American Society of Anesthesiology physical status grade I-II Age 18-80 yr Elective gynecological surgery Supine position Known or predicted difficult airway Body mass index >35 kg m-2 Risk of aspiration | 0 |
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