[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573496":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Patients with a diagnosis of FM after failure and\u002For intolerance of first- and second-line treatment",null,"Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria, aged 18 years and older, able to fully understand and fill questionnaires and to provide fully informed consent, who failed and\u002For were intolerant of first- or second-line treatment.",[13],{"name":14,"affiliation":15,"role":16},"Piercarlo Sarzi Puttini, Medical Doctor","IRCCS Ospedale Galeazzi Sant'Ambrogio","PRINCIPAL_INVESTIGATOR",[18,24],{"name":19,"role":20,"phone":21,"phoneExt":22,"email":23},"Greta Pellegrino, Medical Doctor","CONTACT","0283500010","0039","greta.pellegrino@grupposandonato.it",{"name":14,"role":20,"phone":21,"phoneExt":22,"email":25},"piercarlo.sarziputtini@grupposandonato.it",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":10},"IRCCS Ospedale Galeazzi-Sant'Ambrogio","RECRUITING","Milan","Milano","20157","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.59836,42.78235,{"lat":39,"lon":38},{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100573496","cannabis-extract-in-fibromyalgia-syndrome---the-sunrise-study-100573496",false,"NCT06747039","Cannabis Extract in Fibromyalgia Syndrome - the SUNRISE Study","ObServational StUdy of CaNnabis ExtRact in FIbromyalgia SyndromE","SUNRISE","Inclusion Criteria:\n\n* Patients with a diagnosis of FM according to 2016 American College of Rheumatology Criteria.\n* Patients with FM prescribed cannabis extract Avextra 10\u002F10 solution after failure and\u002For intolerance of first- or second-line treatment.\n* Aged 18 years and older.\n* Able to fully understand and fill questionnaires.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nExclusion Criteria:\n\n* Known history of pain not due to FM.\n* Patients who have not received stable therapy for pain, sleep disorders, or any psychiatric condition for at least 2 weeks.\n* Patients who are taking other types of medical cannabis besides Avextra 10\u002F10 solution.\n* Concomitant diagnosis of other pathologies that could interfere with clinical judgment.\n* Psychiatric diagnosis according to DSM-V-TR\n* Pregnancy or breastfeeding","ALL","18 Years",{"count":54,"type":55},38,"ESTIMATED","OBSERVATIONAL","The aim of this observational study is to evaluate the effects of cannabis extract Avextra 10\u002F10 solution on pain, fatigue, sleep, and quality of life among patients affected by fibromyalgia (FM) syndrome. The main question it aims to answer is:\n\nDoes cannabis extract have a positive effect on pain after 12 weeks in these patients?\n\nParticipants diagnosed from FM will be evaluated and will fill survey about their pain, fatigue, sleep, anxiety, depression and quality of life at baseline, 4 weeks, 8 weeks and 12 weeks after the initiation of cannabis extract Avextra 10\u002F10 solution.",[59],"Fibromyalgia (FM)",[61,62,63,64,65,66],"fibromyalgia","cannabis","pain","fatigue","quality of life","sleep disturbances","2024-12-18",{"date":69,"type":70},"2024-12-24","ACTUAL",{"date":72,"type":70},"2024-12-05",{"date":74,"type":55},"2025-12",{"name":5,"class":6},1]