[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"uterine-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:uterine-diseases":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100629741","multicenter-observational-cohort-study-on-the-epidemiology-of-therapeutic-strategies-in-patients-affected-by-adenomyosis-100629741",false,"NCT07478614","Multicenter Observational Cohort Study on the Epidemiology of Therapeutic Strategies in Patients Affected by Adenomyosis","Adenomyosis","Inclusion Criteria:\n\nAge between 20 and 50 years; Instrumental (ultrasound or MRI) and\u002For histological diagnosis of adenomyosis; Adenomyosis-associated pain with a VAS score ≥ 4 and\u002For presence of heavy menstrual bleeding (HMB) defined as a score \\> 100 on the Pictorial Blood Assessment Chart (PBAC); Provision of written informed consent to participate in the study; Willingness to be followed at the participating center for the entire duration of the study.\n\nExclusion Criteria:\n\nCurrent or previous clinical and\u002For instrumental diagnosis of endometriosis; Suspected or confirmed pregnancy; Inability to understand the purpose of the study and to provide informed consent.","FEMALE","20 Years","50 Years",{"count":20,"type":21},200,"ESTIMATED","OBSERVATIONAL","The primary objective of this multicenter observational cohort study is to evaluate the current medical approach to the management of adenomyosis in women, with particular focus on treatment selection and treatment persistence. The secondary objective is to identify the criteria guiding therapeutic choices in daily clinical practice within a multicenter setting.\n\nAdenomyosis is a benign gynecological condition characterized by the presence of endometrial-like epithelial and stromal tissue within the myometrium. It mainly affects women aged 41 to 45 years and typically presents with symptoms such as chronic pelvic pain, dysmenorrhea, and menorrhagia. The most commonly used treatments include GnRH agonists, progestins, and intrauterine devices (IUDs); however, there are no universally accepted guidelines for the management of this condition, and therapeutic options remain a matter of debate.\n\nThis is a multicenter observational cohort study with both prospective and retrospective recruitment of women affected by adenomyosis. Italian clinical centers will be included and will recruit patients aged between 20 and 50 years, with a diagnosis of adenomyosis confirmed by ultrasound or magnetic resonance imaging (MRI) and\u002For histology, and presenting significant symptoms (VAS ≥ 4 for pelvic pain or bleeding \\> 100 on the Pictorial Blood Assessment Chart - PBAC). Cases of concomitant endometriosis, pregnancy, and conditions preventing informed consent will be excluded.\n\nEach center will collect data regarding the prescribed treatment, its effectiveness, and treatment persistence over time. The study duration will be 12 months, with data collection at baseline (V0), 3 months (V1), 6 months (V2), and 12 months (V3). Approximately 200 patients will be enrolled across 20 centers, with an enrollment period of 12 months.\n\nThe analysis will be conducted based on the frequency of treatment use and changes in treatment response in relation to age, symptoms, and other clinical factors.\n\nData Collection Methodology\n\nPatients will undergo regular clinical evaluations at 3 months, 6 months, and 12 months. Data will be collected using validated questionnaires (VAS, PBAC, SF-12). Transvaginal ultrasound examinations will be performed, and ferritin and hemoglobin levels will be measured. Treatment adherence and tolerability will be monitored through interviews and the recording of adverse events (AEs), including serious adverse events (SAEs).\n\nData Analysis\n\nThe analysis will be descriptive, focusing on the frequency of prescribed treatments and patient characteristics (age, symptoms, comorbidities). Continuous variables will be analyzed using mean and standard deviation (for normally distributed data) or median and range (for non-normally distributed data), while categorical variables will be analyzed using proportions and 95% confidence intervals. Differences between groups will be explored using appropriate statistical tests.\n\nExpected Results and Implications\n\nThis study will provide crucial information on the epidemiology of therapeutic approaches to adenomyosis in Italy, helping to bridge existing knowledge gaps and supporting the development of evidence-based recommendations for clinical management. The results will help guide medical practice, improve patients' quality of life, and contribute to the development of therapeutic guidelines.\n\nDissemination of Results\n\nThe study results will be published in scientific articles in international peer-reviewed journals, with active participation of the physicians involved in the research.",[25,26,27,28],"Adenomyosis of Uterus","Uterine Diseases","Gynecologic Diseases","Menorrhagia, Dysmenorrhea","RECRUITING","2026-03-13",{"date":32,"type":33},"2026-03-17","ACTUAL",{"date":35,"type":33},"2025-06-01",{"date":37,"type":21},"2027-02-01",{"name":39,"class":40},"SCHETTINI SERGIO","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":66,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100367261","research-project-on-reminders-and-self-sampling-can-increase-participation-in-gynecology-cell-sampling---preventive-examination-against-cervical-cancer-100367261","NCT04061967","Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.","Inclusion Criteria:\n\n* Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years.\n\nExclusion Criteria:\n\n* No exclusion except those who do not consent.","33 Years","75 Years",{"count":51,"type":21},20000,"INTERVENTIONAL",[54],"NA","Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken).\n\nInvitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.",[57,58,59,60,61,26,62,63,64,65],"Cervical Cancer","Uterine Cervical Neoplasm","Uterine Neoplasms","Genital Neoplasm","Genital Neoplasm, Female","Genital Diseases, Female","Neoplasms by Site","Neoplasms","Uterine Cervical Disease",[67,68,69],"participation","self sampling","screening","2025-01-10",{"date":72,"type":33},"2025-01-14",{"date":74,"type":33},"2019-08-19",{"date":76,"type":21},"2030-06-01",{"name":78,"class":40},"Karolinska Institutet",6]