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8261. Safety and Efficacy Study of Botulinum Toxin Type A to Treat Glabellar Lines

Exclusion Criteria: Patients with an inability to substantially lessen glabellar lines by physically spreading them apart. Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication Patients with an anaphylactic response history to botulinum toxin type A. Patients who have been administered botulinum toxin type A within the previous 6 months. Pregnant or lactating women. Participation in any research study involving drug

2011 Clinical Trials

8262. Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites

than a week) * Nasal vasoconstrictors (one week)* Acute bacterial rhinosinusitis, systemic hypertension, myocardial infarction (<3 months), recent stroke (<3 months), known arterial aneurysm, epilepsy treatment, drug allergy Inability to measure a change in flow resistance and intra nasal (nasal obstruction complete) History of anaphylaxis to the allergen tested Nasal surgery 6-8 weeks before the study Subject exclusion period (determined by a previous study or in progress) Unable to give informed

2011 Clinical Trials

8263. Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine 2830930A Administered in Toddlers

interfere with the assessment of the study objectives in the opinion of the investigator. Previous receipt of a booster dose (fourth dose) of Synflorix. Anaphylaxis following previous administration of vaccines. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT

2011 Clinical Trials

8264. Transfusion-requirements in Septic Shock Trial

Measures : Persistent organ failure [ Time Frame: Day 5 ] Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy Persistent organ failure [ Time Frame: Day 14 ] Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy Persistent organ failure [ Time Frame: Day 28 ] Defined as need for ventilation, vasopressor/inotrope infusion or renal replacement therapy Anaphylactic/allergic reactions [ Time Frame: Followed up until ICU discharge

2011 Clinical Trials

8265. eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam

of the investigator, could jeopardize the subject's health or would compromise the subject's ability to participate in this study Lifetime history of suicide attempt, or suicidal ideation in the past 6 months Hypersensitivity to any component of lacosamide (LCM) History of acute or sub-acute progressive central nervous system disease History of severe anaphylactic reaction or serious blood dyscrasias Impaired renal function (ie, Creatinine Clearance (CLcr) is lower than 30 mL/min) at Visit 1 History of sick sinus

2011 Clinical Trials

8266. An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A

of an Investigational Medicinal Product within 30 days prior to the first rVIII-SingleChain administration. Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to administration of rVIII-SingleChain or reference product. Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or hamster protein. Any known congenital or acquired coagulation disorder other than congenital FVIII deficiency. Platelet count < 100,000/µL at screening. Human immunodeficiency virus (HIV

2011 Clinical Trials

8267. Tolerance Study of the Silicone Bands on Medical Compression Stockings

of anaphylactic shock. Ongoing antihistamine treatment or having taken during the week before inclusion. Patient on ongoing systemic corticosteroids or having taken corticosteroids in the month before inclusion. Patient having used a topical corticosteroid in the area where the patch tests or prick tests will be performed during the week before inclusion. Phototherapy or sun exposure in the 30 days preceding the skin tests (on the back). Patient having concomitantly used compression stockings and a topical

2011 Clinical Trials

8268. Phase 1 LEISH-F3 Vaccine Trial in Healthy Adult Volunteers

or immunogenicity of the vaccine. Rash, tattoos or any other dermatological condition that could adversely affect the vaccine injection site or interfere with its evaluation. BMI greater than 30 kg/m2 Hypertension (systolic greater than 150 or diastolic greater than 95). History of significant psychiatric illness with current use of medication. Known or suspected alcohol or drug abuse within the past 6 months. Chronic smoker (less than 20 pack years). Subjects with a history of previous anaphylaxis or severe

2011 Clinical Trials

8269. A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis

active disease at both Screening and predose on Day 1 of Period 1. Patient must have had an inadequate response to at least one disease-modifying antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or intolerance. Exclusion Criteria: Pregnant or lactating women Serious medical conditions that would make treatment with CP-690,550 potentially unsafe. A patient who has a history of asthma, multiple allergies or severe allergy (eg, anaphylaxis) to any substance. In particular

2011 Clinical Trials

8270. Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

with Prevenar must not be given to any of the following; History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid Evident pyrexia Evident serious acute disease Any other infants or children ineligible for vaccination Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its

2011 Clinical Trials

8271. Efficacy and Safety Study of Gevokizumab to Treat Moderate to Severe Acne Vulgaris

unresponsive to oral antibiotics Willingness to maintain current habits for facial cleaning, shaving, and application of cosmetics through the end of the study Exclusion Criteria: Use of medications or treatments from specified pre-treatment time periods through the end of the study Beard, moustache, sideburns or other facial hair that may interfere with evaluation Other forms of acne History of malignancy within 5 years History of allergic or anaphylactic reactions to monoclonal antibodies History

2011 Clinical Trials

8272. Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers

with a history of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamos cell carcinomas of the skin that have been completely excised and are considered cured). History of severe allergic or anaphylactic reactions. Known allergy to any component of the IFN B-1a formulation, including a dry rubber allergy. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic

2011 Clinical Trials

8273. Safety of Tuberculosis Vaccine, MVA85A, Administered by the Aerosol Route and the Intradermal Route

or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse History of serious psychiatric condition Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine, sedative drugs, or any local or general anaesthetic agents Any

2011 Clinical Trials

8274. A Study of Rindopepimut/GM-CSF in Patients With Relapsed EGFRvIII-Positive Glioblastoma

receipt of vaccination against EGFRvIII. Any known contraindications to receipt of study drugs, including known allergy or hypersensitivity to keyhole limpet hemocyanin (KLH), GM-CSF (sargramostim; LEUKINE®), polysorbate 80 or yeast derived products, or a history of anaphylactic reactions to shellfish proteins. Use of non-protein based investigational therapy within 14 days prior to Day 1 or use of antibody-based investigational therapy within 28 days prior to Day 1. Clinically significant increased

2011 Clinical Trials

8275. AMG 761 in Adults With Asthma

disorder, as determined by the principal investigator History of life-threatening anaphylaxis Experienced an asthma exacerbation (defined as a disease episode resulting in treatment in an emergency room, hospitalization, or an episode treated with oral corticosteroids in dosage of at least 5 mg/day prednisone or equivalent for ≥ 1 week) during the 6 months prior to enrollment Additional exclusion criteria apply Contacts and Locations Go to Information from the National Library of Medicine To learn more

2011 Clinical Trials

8276. Japanese phase1 Study of Belimumab (IV vs SC)

than 90 mmHg and/or systolic blood pressure drop from supine to standing of greater than 30 mmHg. Rationale: Set in consideration of subjects' safety related to the IV route of administration. Immunoglobulin (M, A, G) level is less than LLN at screening. Rationale: To exclude inappropriate subjects for the evaluation of the safety and pharmacokinetics of GSK1550188. History of anaphylactic reaction to any food, drug, or insect bite/sting. Rationale: To exclude inappropriate subjects

2011 Clinical Trials

8277. Egg Oral Immunotherapy

of eosinophilic esophagitis, where egg has been identified as a causative food. A history of anaphylaxis requiring overnight hospitalization. A history of intubation related to asthma and/or a history of an intensive care unit admission for asthma management. A current diagnosis of severe persistent asthma [FEV1 (forced expiratory volume in 1 second) < 60% of predicted, as defined by NHLBI (National Heart, Lung, and Blood Institute) guidelines, despite current therapy]. A current diagnosis of severe atopic

2011 Clinical Trials

8278. Dose Range Finding Study With rBet v1-FV

by allergens activates an immunological cascade leading to the symptoms of Type I allergy including rhinitis, conjunctivitis, asthma, and anaphylactic shock. Allergic Rhinitis is the most common chronic atopic disease and is associated with considerable cost and co-morbidity. Seasonal allergic rhinitis (SAR), triggered by pollen from trees, grasses and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery, red eyes. Recombinant preparations offer various

2011 Clinical Trials

8279. Single Center Food Allergy Oral Immunotherapy Study

and/or milk and/or tree nut and/or seed allergic subjects between the ages of 4 to 55 years old. Sensitivity to food allergen will be documented by a positive skin prick test result (see Appendix for details) or allergen specific ImmunoCAP IgE level with 7 kU/L as a lower limit of eligibility. Exclusion Criteria: No absolute contraindications are known. However, the risk of serious systemic anaphylactic reactions to food allergens suggests a number of preexisting conditions that should be considered (...) relative contraindications. Among those conditions are acute infections, autoimmune disease, severe cardiac disease, and treatment with beta-adrenergic antagonistic drugs (beta-blockers). Subjects having a history of severe anaphylaxis to food allergens that will be desensitized in this study requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma. Contacts and Locations Go to Information from the National

2011 Clinical Trials

8280. Usefulness of Lidocaine as Topical Pharyngeal Anaesthesia in Esophagogastroduodenoscopy Under Sedation With Propofol

: Percentage of Participants With Adverse Events in Both Groups [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours postprocedure ] Hypoxemia (SatO2<90% or >4% if the baseline was under 93%), bradycardia (<60 bpm or >10% from baseline), hypotension (systolic blood pressure under 90 mmHg and/or diastolic 60 mmHg), anaphylactic reaction, aspiration o methaemoglobinemia. Likert Four Elements Scale to Evaluate the Satisfaction of Endoscopist [ Time

2011 Clinical Trials

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