[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100110272":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":44,"centralContacts":10,"locations":48,"responsibleParty":60,"collaborators":63,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":10,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":88,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The Hospital for Sick Children","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"CF Females",null,"CF females, 14 - 28 years old, sexually mature, with regular menstrual cycles, not on contraceptive Pill. No intervention is being tested - subjects studied with normal menstrual variations in serum hormone levels. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.",[13],"Drug: Hypertonic saline",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-CF Females","Non-CF control females, 14 - 28 years old, sexually mature, with regular menstrual cycles, not on contraceptive Pill. No intervention is being tested - subjects studied with normal menstrual variations in serum hormone levels. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"CF Males","CF males, 14 - 28 years old. No intervention is being tested. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Non-CF males","Non-CF control males, 14 - 28 years old. No intervention is being tested. Hypertonic saline may be used to induce sputum production by subjects who are otherwise unable to produce a satisfactory sputum sample.",[13],[27,34,38,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Hypertonic saline","Subjects will be asked to expectorate sputum samples. If necessary to achieve this, subjects will inhale wet-nebulized 3% saline for up to 7 minutes each for up to 3 cycles.",[9],[33],"Sodium chloride, inhalation;",{"type":28,"name":29,"description":30,"armGroupLabels":35,"otherNames":36},[15],[37],"Sodium chloride, inhalation",{"type":28,"name":29,"description":30,"armGroupLabels":39,"otherNames":40},[19],[37],{"type":28,"name":29,"description":30,"armGroupLabels":42,"otherNames":43},[23],[37],[45],{"name":46,"affiliation":5,"role":47},"Neil Sweezey, MD","PRINCIPAL_INVESTIGATOR",[49],{"facility":5,"status":10,"city":50,"state":51,"zip":10,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":10},"Toronto","Ontario","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.39864,43.70643,{"lat":58,"lon":57},{"type":47,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Neil Sweezey","Staff Respirologist",[64],{"name":65,"class":6},"Unity Health Toronto","100110272","modulation-by-sex-hormones-of-inflammation-and-susceptibility-to-pseudomonas-aeruginosa-in-cystic-fibrosis-airways-100110272",false,"NCT00700050","Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways","Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study","Inclusion Criteria:\n\nFEMALES WITH CF\n\n* Sexually mature female CF patients followed at the Toronto CF Clinics of The Hospital for Sick Children (adolescents) or St. Michael's Hospital (adults)\n* 14-28 years of age\n* Diagnosis of CF is based on a typical clinical picture and confirmed by repeated sweat chloride values \\> 60 mEq\u002FL as determined by pilocarpine ionophoresis (minimum 100mg sweat)\n* Have regular, normal menses\n* Able to give consent on her own behalf\n\nFEMALES WITHOUT CF\n\n* Sexually mature females\n* 14-28 years of age\n* Have regular, normal menses\n* Able to give consent on her own behalf\n\nMALES WITH CF\n\n* Sexually mature male CF patients followed at the Toronto CF Clinics of The Hospital for Sick Children (adolescents) or St. Michael's Hospital (adults)\n* 14-28 years of age\n* Diagnosis of CF is based on a typical clinical picture and confirmed by repeated sweat chloride values \\> 60 mEq\u002FL as determined by pilocarpine ionophoresis (minimum 100mg sweat)\n* Able to give consent on his own behalf\n\nMALES WITHOUT CF\n\n* Sexually mature males\n* 14-28 years of age\n* Able to give consent on his own behalf\n\nExclusion Criteria:\n\n* Is a smoker\n* Has had an upper respiratory tract infection within the preceding two weeks\n* Is taking systemic oral contraceptive therapy\n* Is pregnant\n* Has used furosemide or amiloride or had a pulmonary exacerbation in the previous month (Acute exacerbations are defined as 3 or more of the following symptoms or signs: increased cough, change in volume, colour or thickness of the sputum, fever, hemoptysis, increased shortness of breath, change in their chest radiograph or a fall in pulmonary function (FEV1) of \\>10% from baseline)\n* Unable to give consent on his\u002Fher own behalf",true,"ALL","14 Years","28 Years",{"count":78,"type":79},28,"ACTUAL","OBSERVATIONAL","The general objective is to elucidate the mechanisms whereby sex hormones may modulate the severity of respiratory disease. An important component of this proposal is a systematic and intensive approach to characterize how the cellular and cytokine components of airway inflammation respond to fluctuations in sex hormone levels.\n\nThe effects of menstrual fluctuations in levels of sex hormones on inflammation and bacterial load in respiratory secretions of CF patients will also be determined.",[83],"Cystic Fibrosis",[83,85,86,87],"Sex hormones","Pseudomonas aeruginosa","Paediatrics","COMPLETED","2024-06-27",{"date":91,"type":79},"2024-06-28",{"date":93,"type":79},"2008-04",{"date":95,"type":79},"2014-07-29",{"name":5,"class":6},1]