[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Istituto Giannina Gaslini\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":217},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,72,102,129,160,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100643480","skull-fractures-in-pediatric-emergency-department-the-ultrasound-protocol-100643480",false,"NCT07636902","Skull Fractures in Pediatric Emergency Department: the Ultrasound Protocol","Protocollo di Studio Ecografico Delle Fratture Craniche in Pronto Soccorso Pediatrico","SPEED-UP","Inclusion Criteria:\n\n* 6 years of age or less at enrollment\n* Blunt head trauma with skull haematoma\n* Glasgow Coma Scale (GCS) \\>= 14\n* signature of the informed consent form\n\nExclusion Criteria:\n\n\\- Haemodinamic or neurological instability","ALL","6 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this clinical trial is to compare musculoskeletal ultrasound with the reference standard diagnostic test (cranial CT scan) in patients with minor head trauma associated with scalp hematoma and suspected skull fracture. The primary objective is to assess the diagnostic accuracy of point-of-care ultrasound in detecting skull fractures, in terms of sensitivity, specificity, positive and negative predictive values, and likelihood ratios, using cranial CT as the reference standard.",[27],"Skull Fractures",[29,30,31],"skull fractures","point-of-care ultrasound","pediatric emergency department","RECRUITING","2026-06-05",{"date":35,"type":36},"2026-06-09","ACTUAL",{"date":38,"type":36},"2026-01-01",{"date":40,"type":21},"2027-12-31",{"name":42,"class":43},"Istituto Giannina Gaslini","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":44},"100636276","efficacy-of-oral-sucrosomial-iron-supplementation-in-children-with-celiac-disease-and-iron-deficiency-or-anemia-100636276","NCT07563582","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia","Efficacy of Oral Sucrosomial Iron Supplementation in Children With Celiac Disease and Iron Deficiency or Anemia: a Double-blind, Randomized, Placebo-controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of CD according to the current European ESPGHAN guidelines (clinical or histological) with confirmed hypoferritinemia or iron deficiency anemia.\n2. Age at diagnosis of CD between 8 and 18 years (inclusive).\n3. Absence of oral martial supplementation in the 30 days before the diagnosis and intravenous martial supplementation in the 90 days prior to the diagnosis of CD.\n4. Patients who have not already started GFD before diagnosis.\n5. Exclusion of other causes of anemia.\n6. Patients (and parents\u002Flegal guardian) able to understand and willing to participate in the study, with collaborative attitude.\n7. Informed consent release by both parents\u002Flegal guardian.\n\nExclusion Criteria:\n\n1. Potential celiac disease.\n2. Hb \\\u003C 8 g\u002FdL at screening\n3. Other causes of anemia, hemoglobinopathies or coagulopathies.\n4. Active bleeding or surgery or major trauma in the last 6 months.\n5. Other inflammatory diseases, neoplasms or IgE mediated food allergies\n6. Syndromes or presence of vascular malformations\n7. Pregnant or lactating patients (based on self-certification by the parents and by the patient, where applicable)\\*\n8. Patients with known or suspected allergy or hypersensitivity to the study products or any of their excipients.\n9. Taking oral iron-based medications in the 30 days prior to diagnosis and intravenous iron-based medications in the 90 days prior to diagnosis.\n10. Use of other investigational drug(s) within 30 days before study entry or during the study.\n11. Any other condition, illness or treatment that in the Investigator's opinion does not make the patient suitable for the study.\n\n    * Self-certification of non-pregnancy status is considered sufficient given that the product under study is a safe and well-tolerated dietary supplement that has already been tested in pregnant women.","8 Years","18 Years",{"count":55,"type":21},60,[24],"Celiac disease in children is frequently associated with iron deficiency and\u002For iron deficiency anemia due to intestinal malabsorption and chronic inflammation. Although a gluten-free diet is the standard treatment and can restore iron balance over time, there is currently no clear evidence or consensus on the role and timing of iron supplementation in pediatric patients at diagnosis.\n\nGiven the potential impact of anemia on growth and neurodevelopment, strategies that enable a faster correction of iron deficiency are clinically relevant. Sucrosomial® iron has shown improved absorption and gastrointestinal tolerability compared to conventional oral iron in adult celiac patients.\n\nThis study aims to evaluate whether Sucrosomial® iron supplementation, in addition to a gluten-free diet, is more effective and safe than diet alone in achieving a faster normalization of hemoglobin and iron stores in children with newly diagnosed celiac disease.\n\nThe primary objective of this randomized, double-blind, placebo-controlled, parallel-group study is to assess whether oral supplementation with Sucrosomial® iron, when added to a gluten-free diet (GFD), accelerates the normalization of iron stores and hemoglobin levels compared with GFD alone in school-age children and adolescents newly diagnosed with celiac disease presenting with hypoferritinemia and\u002For iron deficiency anemia.\n\nTarget Study Population: Children and adolescents with celiac disease and iron deficiency or anemia due to iron deficiency.\n\nStudy Duration Total study duration (per patient) will be about 6 months; total treatment duration (per patient) will be 6 months.\n\nNumber of Patients: 60 planned Two typologies of patients will be included: with hypoferritinemia and with anemia due to iron deficiency.\n\nThe randomization process will be stratified, so that:\n\n* 15 patients with hypoferritinemia receive active treatment and 15 patients receive placebo;\n* 15 patients with anemia due to iron deficiency receive active treatment and 15 patients receive placebo.\n\nThe age of patients will also be considered for the randomization (to assign the correct number of product bottles).",[59,60,61],"Celiac Disease in Children","Anemia","Iron Deficiencies",[63],"Iron deficiency\u002Fanemia due to iron deficiency in CD children and adolescents","2026-04-29",{"date":66,"type":36},"2026-05-04",{"date":68,"type":36},"2025-12-23",{"date":70,"type":21},"2027-09",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":4},"100634553","equol-effectiveness-study-100634553","NCT07541183","eQuoL Effectiveness Study","Conduct and Analysis of the Multi-country Effectiveness Study Within the eQuol Project","Inclusion Criteria:\n\n\\- Patients (male or female) with a history of cancer diagnosis before the age of 25 years\n\n* Patients aged between 16 and 30 years old as the study aims to primarily target digital natives who are familiar with mobile applications.\n* To be in follow-up care, completed follow-up, or lost to follow-up before inclusion at one of the institutions participating in the effectiveness study\n* Completed the planned treatment protocol\n* Without evidence of active disease and having been off therapy for at least 5 years since the first tumor diagnosis\n* Able to login and navigate phone apps\n* Sufficient language skills in one of the available study languages\n* With a valid informed consent from the patient, or, for patients younger than 18, valid consent from their parent\u002Fguardian and valid assent from the patient.\n\nExclusion Criteria:\n\nBeing unable to answer the questions of the study questionnaires (not even with help from another person) because of severe mental sequelae or insufficient mastery of the language used;\n\n● currently in treatment for secondary malignancy or relapse of primary malignancy.-","16 Years","30 Years",{"count":82,"type":21},200,"6 Months","OBSERVATIONAL","This prospective cohort study aims to evaluate the implementation and impact of the MyCare eQuoL digital tool across nine clinical sites in Europe: Italy, France, Hungary, Germany, Switzerland, Belgium, Slovenia, Spain, and Norway.\n\nMyCare eQuoL is an innovative digital tool designed to support Childhood, Adolescent and Young Adult Cancer Survivors (CAYACSs) in self-assessing their supportive care needs. Based on a built-in needs assessment, the tool provides tailored feedback including relevant information, self-management strategies, digital resources, and links to online support. It also generates a personalized needs summary to facilitate more targeted discussions with healthcare professionals. Feedback is customized through a \"content suggestion engine\" that is based on personal characteristics (e.g. age, sex, country), on the user's needs assessment, and can consider other data types as well, like the survivors' treatment history, or potential late effects.\n\nThe primary objective of the study is to assess the effectiveness of MyCare eQuoL in improving patient activation among CAYACSs across diverse European healthcare settings. Eligible participants include males and females aged 16-30 who were diagnosed with cancer before age 25, have completed their treatment at least five years prior, are currently disease-free, and have sufficient digital literacy and language proficiency to engage with the app. Exclusion criteria include severe cognitive impairments or ongoing treatment for recurrent or secondary malignancies.\n\nThe study follows a structured data collection timeline. At T0, eligible survivors are identified and invited to participate through mail or telephone. Informed consent and contact details are collected from those who agree to participate. At T1, after obtaining consent, each participant is assigned a unique study ID and attends a clinical visit (either in-person or virtual). During this visit, baseline demographic and treatment data are recorded in a secure electronic Case Report Form (eCRF). Participants are then trained to use the MyCare eQuoL app, complete the baseline questionnaires, and receive a personalized Care Plan and, where available, a digital Passport. At T2, six months post-intervention, participants receive automated reminders to complete follow-up assessments, including validated questionnaires evaluating changes in activation, quality of life, and satisfaction with the tool.\n\nThe primary outcome of the study is the change in patient activation, measured by the Patient Activation Measure (PAM) at baseline and after six months. Secondary outcomes include changes in health-related quality of life (EORTC-AYA), patient-reported experience measures (PREMs), and a cost-effectiveness evaluation. To detect a clinically meaningful 4-point difference in PAM scores, with an assumed standard deviation of 20 and Type I and II error rates of 5% and 20%, respectively, the study requires 199 participants. Accounting for a 20% dropout rate, a total of 239 participants will be recruited.\n\nPrimary outcome analysis will be conducted using multivariable logistic regression, while secondary outcomes will be analysed descriptively. Economic evaluation will include cost analysis, cost-utility analysis, and multi-criteria decision analysis.\n\nThe study will be conducted in compliance with the principles of Good Clinical Practice (ICH\u002FGCP) and the Declaration of Helsinki. The project will be registered at ClinicalTrials.gov. The research team will ensure adherence to all applicable ethical, legal, and safety regulations at both national and EU levels.",[87],"Childhood Cancer Survivors",[89,90,91,92],"digital tool","psychosocial support","cancer","childhood cancer survivors","NOT_YET_RECRUITING","2026-04-20",{"date":96,"type":36},"2026-04-23",{"date":98,"type":21},"2026-05",{"date":100,"type":21},"2027-06",{"name":42,"class":43},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":17,"minAge":110,"maxAge":53,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100629729","adris-driving-simulator-for-adolescents-with-attention-deficit-and-hyperactivity-disorder-100629729","NCT07478458","ADRIS Driving Simulator for Adolescents With Attention Deficit and Hyperactivity Disorder","ADRIS-ADHD","Inclusion Criteria for ADHD subjects:\n\n* Age range 13-18 years (up to the age of nineteen)\n* Diagnosis of ADHD (hyperactive, inattentive and combined subtype)\n* Consent to participate in the study by the participant or, in the case of a minor, by their parent(s)\u002Fguardian(s).\n\nInclusion Criteria for Control Group subjects:\n\n* Age- and sex-matched neurotypical adolescents\n* No diagnosis of ADHD or other neurodevelopmental disorders\n* Informed consent obtained from the participant if of legal age or from the legal guardian and assent from the minor\n\nExclusion Criteria:\n\n* Visual deficits not corrected\u002Fcorrectable with the normal use of lenses.\n* Motor deficits clinically detected and\u002For previously diagnosed and that could compromise the use of the simulator (e.g. neurological diseases, psychiatric diseases, etc.).\n* Categorical diagnoses according to DSM-5 criteria such as Psychosis, Mood Disorders, Autism Spectrum Disorders, Intellectual Disabilities, Borderline Intellectual Functioning, Anxiety Disorders.\n* Patients with other conditions that could affect driving ability.\n* Denial \u002F withddrawal of consent to the protocol",true,"13 Years",{"count":112,"type":21},120,[24],"This study aims to evaluate a new driving simulator, called ADRIS 2.1, developed for adolescents aged 13-18 years with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a common neurodevelopmental disorder that can affect attention, self-control, and decision-making. These challenges may impact daily activities, including driving.\n\nThe ADRIS simulator allows participants to \"drive\" in a virtual environment while their performance is monitored. The system measures driving errors (such as not stopping at red lights), head and body movements, and heart rate, helping researchers understand how ADHD may affect driving-related behavior.\n\nParticipants in the study will include both adolescents with ADHD and typically developing adolescents. All participants will complete standardized cognitive and behavioral assessments and take part in at least one driving simulation session. Adolescents with ADHD will return for follow-up visits and a subgroup will participate in a 6-week training program using the simulator.\n\nThe main goal of the study is to measure differences in driving performance and attention between adolescents with and without ADHD. The study will also explore whether the simulator can detect improvements over time and in response to clinical treatment or simulator-based training.\n\nThe results may help inform future clinical evaluations and support tools for adolescents with ADHD, with the potential to improve safety and quality of life.",[116],"ADHD - Attention Deficit Disorder With Hyperactivity",[118,119],"ADHD","Driving simulator","2026-03-13",{"date":122,"type":36},"2026-03-17",{"date":124,"type":36},"2025-11-10",{"date":126,"type":21},"2028-01",{"name":42,"class":43},2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":137,"minAge":53,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":44},"100621977","phase-4-intrathecal-morphine-versus-transabdominal-plane-block-tap-block-for-analgesic-management-in-elective-caesarean-section-100621977","NCT07377630","Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section","Intrathecal MoRphine Versus Transabdominal Plane Block (TAP) Block for AnalGesic Management in Elective Caesarean Section Performed Under Neuraxial Anesthesia. A Monocentric Pilot Randomized Controlled Trial","MIRAGE","Inclusion Criteria:\n\n* Planned for elective Cesarean Section (CS)\n* Scheduled for spinal anesthesia\n* Gestational age \\> 34 weeks\n* Age 18 years or above\n* Ability to read and understand the information sheet and to sign and date the consent form\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification \\>2\n* Body Mass Index (BMI) ≥ 40 kg\u002Fm2\n* Weight \\\u003C 50 kg\n* Height \\\u003C 150 cm or ≥ 180 cm\n* Complicated Pregnancy (abnormal placentation, preeclampsia or others)\n* Women with opioid use disorder\n* Contraindication to spinal anesthesia (clotting disorder, local infection, spinal malformation, elevated intracranial pressure)\n* Contraindication to Transabdominal Plane Block (TAP) block (skin infection, abdominal wall muscle defects)\n* Allergy\u002Fcontraindication to any medication used in the study\n* Previous median abdominal incision\n* Emergency or unplanned CS","FEMALE",{"count":139,"type":21},100,[141],"PHASE4","The goal of this randomized controlled clinical trial is to determine if low-dose intrathecal morphine is superior to a Transversus Abdominis Plane (TAP) block with ropivacaine and clonidine for postoperative analgesia in women aged 18 years or older undergoing elective cesarean section under neuraxial anesthesia.\n\nThe main questions it aims to answer are:\n\n* Is intrathecal morphine more effective than TAP block in reducing postoperative somatic pain at rest?\n* Does intrathecal morphine differ from TAP block in terms of adverse events, pain during mobilization, visceral pain, rescue analgesic use, maternal satisfaction, and newborn wellbeing?\n\nResearchers will compare the intrathecal morphine (ITM) group to the TAP block (TB) group to see if ITM provides superior analgesia and improved secondary outcomes.\n\nParticipants will:\n\n* Undergo spinal anesthesia with hyperbaric bupivacaine and sufentanil\n* add 30 μg intrathecal morphine (only ITM group)\n* receive bilateral ultrasound-guided TAP block with 20 ml ropivacaine 0.25% and 75 μg clonidine per side (only TB group)\n* receive standardized postoperative analgesia with paracetamol, ibuprofen, and tramadol as needed\n* be monitored postoperatively for pain (somatic and visceral, at rest and with movement), adverse events, mobilization, maternal satisfaction, and newborn outcomes at regular intervals for 24 hours\n\nThis is a single-center, pilot, single-blind trial involving 100 participants (50 per group).",[144,145,146],"Pregnancy","Cesarean Section","Neuroaxial Analgesia Procedures",[148,149,150,151],"cesarean section","neuraxial anesthesia","TAP block","morphine","2026-01-22",{"date":154,"type":36},"2026-01-30",{"date":156,"type":21},"2026-03-01",{"date":158,"type":21},"2027-03-02",{"name":42,"class":43},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":172,"briefSummary":174,"conditions":175,"keywords":178,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":44},"100341660","phase-3-step-up-and-step-down-therapeutic-strategies-in-childhood-arthritis-100341660","NCT03728478","STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS","Comparison of STep-up and Step-down Therapeutic Strategies in Childhood ARthritiS","STARS","Inclusion Criteria\n\nEach patient must meet all the following criteria in order to be enrolled in the trial:\n\nI. Newly-diagnosed and synthetic or biologic DMARD-naïve children (only treatment with 1 NSAID is allowed and no corticosteroid joint injections prior to randomization ) with a JIA classified according to the following ILAR categories:\n\ni. Oligoarthritis ii. Rheumatoid factor negative polyarthritis\n\nII. Active arthritis\n\nIII. Onset of JIA symptoms no more than 6 months before randomization\n\nIV. Age 2 to 17 years at enrolment.\n\nV. Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must agree to use highly effective contraceptive measures, throughout study participation, and must have no intention of conceiving during the course of the study. Post-pubertal males must have no plans to father a child during the study and agree to use highly effective contraceptive measures if sexually active.\n\nVI. Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and\u002For patients, as appropriate\n\nVII. Duly executed, written, informed consent\u002Fassent obtained from the parents\u002Fpatient.\n\nExclusion criteria\n\nI. Classification in one of the following JIA categories: systemic arthritis, RF-positive polyarthritis, psoriatic arthritis, enthesitis-related arthritis, undifferentiated arthritis\n\nII. Patients who need systemic treatment for uveitis\n\nIII. Tuberculosis related issues: patients are excluded from the study if they have:\n\n1. Active TB or a history of incompletely treated TB\n2. PPD or QuantiFERON-TB positive patients (with no active disease) unless it is documented by a specialist that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the study investigator and \u002F or an infectious disease specialist.\n3. Suspected extrapulmonary TB infection\n4. Patients at high risk of contracting TB, such as close contact with individual with active or latent TB\n\nIV. Previous treatment with any synthetic or biologic DMARD\n\nV. Any live attenuated vaccine within 4 weeks prior to the baseline visit, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines and throughout the study. Killed or inactive vaccine may be permitted based on the investigator's judgment\n\nVI. Prior or current history of malignancy or any other significant concomitant illness(es) as per the treating physician evaluation\n\nVII. Any of the following laboratory abnormalities based on the most recent laboratory results:\n\n1. White blood cell (WBC) count \\\u003C3.50 x 103\u002Fmm3 (SI units: \\\u003C3.50 x 109\u002FL) and neutrophils \\\u003C 1x109\u002FL;\n2. Hemoglobin \\\u003C 8.5 g\u002FdL (SI units: \\\u003C85 g\u002FL);\n3. Platelet Count \\\u003C 125,0000\u002Fmm3 or ≥1,000,000\u002Fmm3 (SI units: \\\u003C125 x 109\u002FL or ≥1,000 x 109\u002FL\n4. Aspartate aminotransaminase (AST) or alanine aminotransaminase (ALT) ≥ 2.0 x upper limit of normal (ULN).","2 Years","17 Years",{"count":171,"type":21},260,[173],"PHASE3","This study aims to compare the effectiveness of a conventional therapeutic regimen, based on treatment escalation (step-up strategy) and driven by the treat-to-target approach, with that of an early aggressive intervention based on the initial start of a combination of conventional and biological DMARDs (step-down strategy).",[176,177],"Oligoarthritis, Juvenile","Polyarthritis, Juvenile, Rheumatoid Factor Negative",[179,180,181],"juvenile idiopathic arthritis","treatment","treat to target","2024-10-09",{"date":184,"type":36},"2024-10-15",{"date":186,"type":36},"2019-05-29",{"date":188,"type":21},"2025-02-28",{"name":42,"class":43},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":53,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":44},"100563651","phase-4-toward-personalized-medicine-to-guide-drug-withdrawal-in-children-with-juvenile-idiopathic-arthritis-in-clinical-remission-100563651","NCT06618937","Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission","Toward Personalized Medicine to Guide Drug Withdrawal in Children with Juvenile Idiopathic Arthritis in Clinical Remission: a Randomized Clinical Trial Comparing Early Versus Late Drug Withdrawal Combining Imaging and Multi-Omics","Re-JIA","Inclusion Criteria:\n\n* \\- Children with a diagnosis of JIA according to the ILAR classification criteria\n* JIA patients who satisfy criteria for inactive disease for a minimum of 6 continuous months while still taking medication.\n* Patients who have been treated with cs\u002Fb\u002Fbs\u002Fts DMARDs according to the label indication\n* Ability to comply with the entire study procedures, ability to communicate meaningfully with the investigational staff, competence to give written informed consent; to be applied to the parents and\u002For patients, as appropriate\n* Duly executed, written, informed consent obtained from the patient's parents\u002Flegal guardian\n* Female of child-bearing potential must have a negative pregnancy test at the beginning of the trial. If sexually active, they must have no intention of conceiving while on treatment with antirheumatic drugs.\n\nExclusion Criteria:\n\n* \\- Patients with systemic JIA according to ILAR criteria\n* Patients with undifferentiated arthritis according to ILAR criteria\n* Patients with severe disease-related ocular damage and who need systemic treatment for uveitis\n* Patients who received glucocorticoid treatment 3 months prior to baseline visit\n* Patients who had previously unsuccessfully attempted tapering cs\u002Fb\u002Fbs\u002FtsDMARDs\n* Patients with severe damage as per caring physician measured\n* Prior or current history of other significant concomitant illness(es) that, according to the Investigator's judgment, would adversely affect the patient's participation in the study\n* Any other medical condition or laboratory examination which in the opinion of the caring physician should exclude the patient from participation to the study",{"count":199,"type":21},166,[141],"Biologic therapies made clinical remission an achievable goal for most juvenile idiopathic arthritis (JIA) patients. Nevertheless, antirheumatic drugs have side effects and are costly. Currently, no guidelines exist for withdrawing drugs in JIA patients with clinical inactive disease (CID). Relapses following the withdrawal of antirheumatic drugs are common. To establish an optimal timeline for treatment discontinuation is a major unmet need in pediatric rheumatology.\n\nIt is hypothesized that biomarkers-guided early withdrawal of antirheumatic drugs in patients achieving clinical, imaging and biological remission is safe and more effective compared to the standard practice of maintenance of stable treatment over 12 months.",[203],"Juvenile Idiopathic Arthritis (JIA)",[205,206,207,208],"JIA","imaging","omics","withdrawal","2024-09-27",{"date":211,"type":36},"2024-10-01",{"date":213,"type":21},"2025-01-01",{"date":215,"type":21},"2029-01-01",{"name":42,"class":43},""]