[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":642},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,43,0,25,[9,43,72,101,121,153,176,202,225,253,281,304,331,352,372,396,416,439,459,481,510,532,554,580,614],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":4,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053762","morphological-and-functional-biomarkers-of-skeletal-muscle-adaptations-in-sarcopenia-100053762",false,"NCT07692308","Morphological and Functional Biomarkers of Skeletal Muscle Adaptations in Sarcopenia","Morphological and Functional Biomarkers of Skeletal Muscle Adaptations for Early Detection of Sarcopenia and of the Therapeutic Effects of a Home-Based Exercise Intervention: A Randomized-Controlled Trial","EXEDOS","Inclusion Criteria:\n\n* Sedentary individuals aged over 50 years.\n* Individuals with sarcopenia, defined as reduced muscle mass assessed by bioelectrical impedance analysis and reduced muscle strength assessed by handgrip strength, according to EWGSOP2 criteria.\n* Individuals at risk of sarcopenia, defined as reduced muscle mass with preserved muscle strength.\n* Healthy age-, sex-, and physical activity-matched older adults eligible for inclusion in the reference cohort.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Hospitalization within the previous 6 weeks.\n* Substance or alcohol abuse.\n* Use of medications that may impair balance or coordination.\n* Major locomotor impairments.\n* Inability to complete the exercise protocol.\n* Medical, cognitive, or functional conditions that, in the opinion of the investigators, may interfere with safe participation, adherence to the study procedures, or completion of the follow-up assessments.",true,"ALL","50 Years",{"count":22,"type":23},192,"ESTIMATED","INTERVENTIONAL",[26],"NA","Sarcopenia is an age-related condition characterized by progressive loss of skeletal muscle mass, muscle strength, and physical performance. It is associated with frailty, falls, disability, reduced independence, lower quality of life, and increased healthcare burden. Despite its clinical relevance, sarcopenia remains underdiagnosed, partly because current diagnostic approaches may be difficult to implement broadly in clinical practice and may not fully capture early changes in muscle quality and neuromuscular function.\n\nThe EXEDOS study aims to evaluate an integrated diagnostic and therapeutic strategy for the early detection and management of sarcopenia. The study will assess Quantitative Ultrasound with Radio-Frequency analysis (QUS-RF) as a non-invasive, accessible, and radiation-free tool to characterize muscle morphology, microstructure, and quality. QUS-RF-derived parameters will be compared with established assessments, including body composition, muscle strength, physical performance, and imaging-based measures, to determine their feasibility, reliability, diagnostic accuracy, and responsiveness to change.\n\nThe study also includes a 48-week randomized, parallel-group, open-label superiority trial designed to evaluate the effects of a digitally delivered home-based exercise intervention in older adults with sarcopenia or at risk of sarcopenia. Eligible participants will be randomized to either an experimental group receiving a structured home-based exercise program or a control group receiving general physical activity recommendations in line with current guidelines. The exercise program will combine progressive resistance and aerobic training and will be supported by a digital platform allowing remote monitoring, feedback, and supervision. All participants will receive general nutritional advice.\n\nAssessments will be performed at baseline, Week 12, and Week 48. The primary outcome of the randomized trial will be the change in 30-second Chair Stand Test performance, used as an indicator of lower-limb muscle function. Secondary outcomes will include handgrip strength, lower-limb maximal and explosive strength, walking capacity, balance, body composition, QUS-RF-derived muscle parameters, quality of life, mood, physical activity, dietary indicators, blood biomarkers, adherence to the intervention, and safety. A health economic analysis will also be conducted to estimate the potential cost-effectiveness and cost-utility of the proposed diagnostic and therapeutic strategy.\n\nBy combining innovative muscle assessment with a scalable digitally supported exercise intervention, the EXEDOS study aims to improve early sarcopenia detection, personalize exercise prescription, and support the development of sustainable strategies to preserve muscle function and independence in older adults.",[29],"Sarcopenia","RECRUITING","2026-07-09",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2026-06-03",{"date":38,"type":23},"2029-06-03",{"name":40,"class":41},"I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":42},"100644498","predictors-of-major-adverse-limb-events-after-endovascular-iliac-stenting-a-real-world-cohort-study-100644498","NCT07672249","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study","Predictors of Major Adverse Limb Events After Endovascular Iliac Stenting: a Real-world Cohort Study (PREMISE-ILIAC Study)","PREMISE-ILIAC","Inclusion Criteria:\n\nAdult patients aged ≥18 years, of both male and female sex\n\n* Presence of haemodynamically significant stenosis or occlusion of the common iliac artery (CIA) and\u002For external iliac artery (EIA), documented by computed tomography angiography, magnetic resonance angiography, or diagnostic angiography\n* Symptomatic peripheral artery disease, including lifestyle-limiting intermittent claudication (Rutherford category 2-3) or chronic limb- threatening ischaemia (CLTI; Rutherford category 4-6), refractory to optimal medical therapy\n* Treatment with endovascular iliac artery stenting (covered or uncovered; balloon-expandable or self-expanding devices) as the primary revascularisation strategy\n* De novo iliac lesions only\n* Availability of complet\n\nExclusion Criteria:\n\nPrimary open surgical revascularisation of the iliac axis (e.g., aorto- bifemoral bypass or endarterectomy).\n\n* Previous stenting of the target iliac segment (in-stent restenosis cases excluded).\n* Aorto-iliac aneurysmal disease as the primary indication for treatment (including EVAR or fenestrated endografts).\n* Hybrid procedures with concomitant infrainguinal bypass surgery.\n* Incomplete clinical, procedural, or follow-up data preventing assessment of study endpoints.\n* Loss to follow-up without documented clinical outcomes.","18 Years",{"count":53,"type":23},98,"OBSERVATIONAL","Peripheral arterial disease involving the iliac arteries is a common manifestation of systemic atherosclerosis and a major cause of lifestyle-limiting claudication and chronic limb-threatening ischemia. Endovascular iliac artery stenting has become the preferred treatment strategy for most iliac lesions, including complex TransAtlantic Inter-Society Consensus II (TASC II) C and D lesions, owing to high technical success rates and lower perioperative morbidity compared with open surgical reconstruction.\n\nDespite widespread adoption of endovascular treatment, available evidence regarding predictors of major adverse limb events (MALE) after iliac artery stenting remains limited, particularly in unselected real-world populations with substantial comorbidity burden. Patient-related factors, including frailty, may contribute to post-procedural outcomes in addition to lesion-related characteristics.\n\nThis retrospective single-center cohort study will evaluate clinical outcomes following endovascular iliac artery stenting in consecutive adult patients treated at IRCCS Galeazzi-Sant'Ambrogio Hospital, Milan, Italy. The study will assess the occurrence of major adverse limb events (MALE), primary patency, peri-procedural complications, target lesion revascularization, restenosis or occlusion, and all-cause mortality. Clinical, anatomical, and procedural factors associated with adverse limb outcomes, including frailty assessed by the modified five-item Frailty Index (mFI-5), will also be investigated.",[57,58,59,60],"Peripheral Arterial Disease","Aortoiliac Occlusive Disease","Chronic Limb-Threatening Ischemia","Intermittent Claudication",[57,62,63],"Iliac Artery Stenting","Endovascular Revascularization","2026-06-26",{"date":66,"type":34},"2026-06-30",{"date":68,"type":34},"2026-06-16",{"date":70,"type":23},"2026-07-16",{"name":40,"class":41},{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":42},"100640836","greenwater-20-reducing-iodinated-contrast-agents-in-hospital-wastewater-100640836","NCT07620093","GREENWATER 2.0: Reducing Iodinated Contrast Agents in Hospital Wastewater","GREENWATER 2.0: Cutting Edge Solution for Reducing Iodinated Contrast Agents Via Post-Administration Collection Device","GREENWATER 2","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients scheduled for a clinically indicated contrast-enhanced CT scan with iodinated contrast agent.\n* Patients able to provide written informed consent.\n* Patients willing to wait approximately 60 minutes after contrast injection before using the dedicated urine collection device.\n\nExclusion Criteria:\n\n\\- Patients unable to use the dedicated urine collection device for urine collection.",{"count":81,"type":23},416,"The goal of this observational study is to learn if using a dedicated urine collection device after CT scans can help reduce the amount of iodinated contrast agent released into hospital wastewater in adult outpatients undergoing contrast-enhanced CT scans.\n\nThe main questions it aims to answer are:\n\n* Does the dedicated urine collection device improve patient acceptance and compliance with post-contrast urine collection?\n* How much iodinated contrast agent can be recovered from urine collected after CT scans?\n\nParticipants will:\n\n* Have their planned CT scan with iodinated contrast agent as part of their regular medical care.\n* Wait in the radiology department for about 60 minutes after the contrast injection.\n* Use a dedicated urine collection device before leaving the hospital.\n* Answer short questions about their experience with the device.\n\nThis does not change the CT scan, the contrast agent used, or the standard clinical imaging procedure. The only additional procedure is the use of the dedicated urine collection device after the scan.",[84,85],"Environmental Sustainability in Radiology","Iodinated Contrast Agent Recovery",[87,88,89,90,91,92],"Iodinated Contrast Agents","Contrast-Enhanced CT","Hospital Wastewater","Urine Collection","Environmental Sustainability","Radiology Sustainability","2026-06-19",{"date":95,"type":34},"2026-06-24",{"date":97,"type":34},"2026-03-10",{"date":99,"type":23},"2026-12",{"name":40,"class":41},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100631413","the-influence-of-perioperative-strategies-on-the-extent-of-in-orthopaedic-prosthetic-surgery-100631413","NCT07500350","The Influence of Perioperative Strategies on the Extent of in Orthopaedic Prosthetic Surgery","Influence of Perioperative Strategies on the Extent of Total Blood Loss in Orthopaedic Prosthetic Surgery","IPECO","Inclusion criteria:\n\n\\- Adult patients in ASA Class I-II-III undergoing prosthetic surgery, as a first-time implant\n\nExclusion criteria:\n\n* Patients who did not receive tranexamic acid prophylaxis (pre-operative and post- operative doses) and are therefore not comparable with the vast majority of cases.\n* Reintervention, as bleeding depends on a variable that is not constant, namely the initial implant",{"count":110,"type":23},1683,"To assess the extent of blood loss in prosthetic surgery, considering whether possible variables may influence, either positively or negatively, the extent of such loss. The assessment will be carried out by analysing parameters (haemoglobin - haematocrit) in the immediate preoperative period and then on days 1-3 and 7.\n\nNumerous clinical studies have examined blood loss - both intraoperative and, above all, total blood loss - in shoulder, hip and knee replacement surgery.\n\nAnaesthetic and surgical techniques, relevant medications, the use of pneumatic tourniquets and, more simply, intraoperative positioning, as well as blood-sparing and blood recovery methods, have been the subject of extensive literature. Our study aims to retrospectively evaluate a full year of prosthetic surgery, analysing all the factors involved in the search for a definitive answer regarding the best method for this purpose, if feasible \\[1,2,3,4,5\\].\n\nPrior to admission, the patient undergoes a standardised series of tests, which also include a complete blood count, serum iron, transferrin and ferritin levels.\n\nThis series of tests concerning haematocrit and haematopoietic function is then repeated on the 1st, 3rd and 7th post-operative days to assess overall blood loss\n\n. Patients of both sexes who have undergone total knee replacement (unilateral or bilateral), unicompartmental and total knee replacement (unilateral or bilateral), and total shoulder replacement.\n\nThe above patients operated on between January 2025 and December 2025 at the San Siro Clinic.",[113],"Orthopaedic Surgery","NOT_YET_RECRUITING",{"date":95,"type":34},{"date":117,"type":23},"2026-07-08",{"date":119,"type":23},"2028-03",{"name":40,"class":41},{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":42},"100643107","augmented-reality-in-surgery-100643107","NCT07636278","Augmented Reality in Surgery","Artificial Intelligence-Based Identification of the Target Zone on Arthroscopic Images During Knee Anterior Cruciate Ligament Reconstruction: An Observational Study","ARS","Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for primary arthroscopic anterior cruciate ligament reconstruction at IRCCS Galeazzi-Sant'Ambrogio\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Revision anterior cruciate ligament reconstruction\n* Arthroscopic video quality judged inadequate by the investigator (artefacts, insufficient illumination, uninterpretable images)\n* Failure to sign informed consent, or withdrawal of consent",{"count":130,"type":23},100,"The goal of this observational study is to learn whether an artificial-intelligence software can reliably recognise the anatomical landmarks used to guide femoral bone tunnel placement on the arthroscopic monitor image during anterior cruciate ligament (ACL) reconstruction in adults. The main questions it aims to answer are:\n\nCan the software automatically tell when the arthroscopic image is clean enough to allow identification of these landmarks? Can the software accurately outline the key bony and cartilaginous landmarks on the femur that guide correct tunnel positioning?\n\nParticipants will undergo their clinically indicated ACL reconstruction without modifications: short video sequences of the operative field will be recorded from the arthroscopic camera already used in routine practice, and used to train and validate the algorithms. No additional devices, manoeuvres or operative time are required.",[133],"Anterior Cruciate Ligament (ACL) Tear",[135,136,137,138,139,140,141,142,143,144,145],"Anterior Cruciate Ligament Reconstruction","Arthroscopy","Artificial Intelligence","Deep Learning","Computer Vision","Semantic Segmentation","Augmented Reality","Surgery, Computer-Assisted","Image Processing","Femoral Tunnel","Decision Support Systems",{"date":147,"type":34},"2026-06-09",{"date":149,"type":34},"2026-05-26",{"date":151,"type":23},"2027-05-31",{"name":40,"class":41},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":24,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":42},"100634945","the-use-of-two-bone-substitutes-in-adjunct-to-emd-for-the-treatment-of-one--and-two-wall-intrabony-defects-100634945","NCT07546279","The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.","2 Title The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.","OSSIXPERIO","Inclusion Criteria:\n\n* Men and women over or equal to the age of 18 years\n* Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2)\n* Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular \u002F buccal or the lingual support bone wall (PPD lingual or vestibular \u002F buccal \\\u003C= 3.5 mm ) of the affected teeth.\n* Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility\n* Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules\n* Patients who had provided written informed consent to participate in the study prior to any study procedure.\n\nExclusion Criteria:\n\n* FMPS% \\> 15% at the time of recruitment\n* FMBS% \\> 15% at the time of recruitment\n* Treatment with anticoagulant drugs (INR above 2,5)\n* Treatment with intravenous bisphosphonates\n* Treatment with anticonvulsants drugs\n* patients with history of alcohol, narcotics, or drug abuse\n* Patients receiving radiotherapy, chemotherapy, or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years\n* Patients through at any time received radiotherapy to the head and neck region will be excluded anyway\n* Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia\n* Degenerative diseases\n* Osteoradionecrosis\n* Renal failure\n* Organ transplant recipients\n* HIV positive (self-declaration)\n* Malignant diseases\n* Diseases that compromise the immune system\n* Unbalanced diabetes. (HbA1c above 7.2 assessed by self-declaration)\n* Psychotic diseases\n* Hypersensitivity or specific contraindications to one of the components of any of the products used in the study\n* Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery\n* Site where a history of failed periodontal regenerative procedure in the last two years\n* Heavy Smokers (5 cigarettes and more per day)\n* Other uncontrolled systemic diseases\n* disorders or treatments that compromise wound healing\n* chronic high dose steroid therapy\n* bone metabolic diseases",{"count":162,"type":23},40,[26],"The main aim will be to evaluate the difference in PD changes at 12-month follow-up, measured from the gingival margin to the base of the pocket, comparing periodontal regeneration using two different bone substitutes, that is bovine derived xenograft granules (BioOss® Collagen) and one resorbable sponge-like hydroxyapatite collagen matrix (OssixTM Bone), in adjunct with EMD after microsurgical flap elevation.\n\nInclusion criteria I. Men and women over or equal to the age of 18 years II. Patients in general good health in the opinion of the principal investigator as determined by medical history and clinical examination (ASA 1 or ASA-2) III. Clinical evidence of periodontitis, with one interdental area of PPD (periodontal probing depth) ≥6mm and bleeding on probing, associated one or more one-wall or two-wall intrabony periodontal defect with an intrabony component of equal or more than 3 mm, as diagnosed by periapical radiographs and clinical evaluation (excluding third molars and distal of second molars); the defect must not affect the vestibular \u002F buccal or the lingual support bone wall (PPD lingual or vestibular \u002F buccal \\\u003C= 3.5 mm ) of the affected teeth.\n\nIV. Patients who already underwent stage I and stage II of periodontal therapy, as described in the EFP practice guidelines (Sanz et al., 2020), within 6 months prior to assessment for eligibility V. Patients who can understand the requirements of the study and are willing and able to comply with its instructions and schedules VI. Patients who had provided written informed consent to participate in the study prior to any study procedure.\n\nExclusion criteria I. FMPS% \\> 15% at the time of recruitment II. FMBS% \\> 15% at the time of recruitment III. Treatment with anticoagulant drugs (INR above 2,5) IV. Treatment with intravenous bisphosphonates V. Treatment with anticonvulsants drugs VI. patients with history of alcohol, narcotics, or drug abuse VII. Patients receiving radiotherapy, chemotherapy, or any other immunosuppressive treatment or who have been administered radiotherapy in the last 5 years VIII. Patients through at any time received radiotherapy to the head and neck region will be excluded anyway IX. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia X. Degenerative diseases XI. Osteoradionecrosis XII. Renal failure XIII. Organ transplant recipients XIV. HIV positive (self-declaration) XV. Malignant diseases XVI. Diseases that compromise the immune system XVII. Unbalanced diabetes. (HbA1c above 7.2 assessed by self-declaration) XVIII. Psychotic diseases XIX. Hypersensitivity or specific contraindications to one of the components of any of the products used in the study XX. Women who are pregnant (self-declaration); or lactating at the time of recruitment and of surgery XXI. Site where a history of failed periodontal regenerative procedure in the last two years XXII. Heavy Smokers (5 cigarettes and more per day) XXIII. other uncontrolled systemic diseases XXIV. disorders or treatments that compromise wound healing XXV. chronic high dose steroid therapy XXVI. bone metabolic diseases",[166,167],"Periodontitis","Bone Defects","2026-04-16",{"date":170,"type":34},"2026-04-22",{"date":172,"type":34},"2025-05-08",{"date":174,"type":23},"2029-05",{"name":40,"class":41},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":42},"100631704","the-orienting-study-100631704","NCT07504146","The Orienting Study","The Natural History Of Calcium Pyrophosphate Deposition And Gout: An Observational Clinical And Imaging Study - The Orienting Study","ORIENTING","The inclusion criteria for CPPD patients are:\n\n* Patients diagnosed with CPPD disease according to the ACR\u002FEULAR 2023 classification criteria.\n* Patients with evidence of asymptomatic CPPD on US or X-rays (not meeting the classification criteria) according to validated imaging definitions.\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for gout patients are:\n\n* Patients diagnosed with gout according to the ACR\u002FEULAR 2015 classification criteria.\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe inclusion criteria for disease controls are:\n\n* A diagnosis of OA according to ACR classification criteria\n* No evidence of uric acid or calcium pyrophosphate deposits on US\n* Uric acid \\\u003C 6 mg\u002FdL\n* Aged older than 18 years.\n* Able to provide informed consent, according to requirements of local IRB\u002Fethics committee\n\nThe exclusion criteria for gout\u002FCPPD patients are:\n\n* Known history of other inflammatory arthropathies\n* Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.\n\nThe exclusion criteria for disease controls are:\n\n* Known history of other inflammatory arthropathies\n* Unable to provide informed consent, according to requirements of local IRB\u002Fethics committee.",{"count":185,"type":23},450,"This study at IRCCS Galeazzi - Sant'Ambrogio Hospital involves patients with gout, CPPD, and osteoarthritis as a control group. Patients will receive routine care with regular clinical, laboratory, and imaging assessments every six months, alongside urgent visits as needed. The study aims to understand crystal deposits in joints and blood vessels and monitor their progression over time, assessing how these deposits respond to standard treatments and if they are associated with cardiovascular complications. Data will be collected from medical records over a follow-up period of up to 10 years, offering long-term insights into disease impact and treatment effectiveness.",[188,189],"CPPD - Calcium Pyrophosphate Deposition Disease","Gout",[191,189,192,193],"CPPD","Osteoarthritis","Ultrasound","2026-03-25",{"date":196,"type":34},"2026-03-31",{"date":198,"type":34},"2024-10-30",{"date":200,"type":23},"2039-10-30",{"name":40,"class":41},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":24,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":42},"100628065","use-of-cryopressotherapy-in-patiens-undergoing-total-knee-replacement-to-improve-clinical-outcome-100628065","NCT07456787","Use of Cryopressotherapy in Patiens Undergoing Total Knee Replacement to Improve Clinical Outcome","CRYO-KNEE","Inclusion Criteria:\n\n* Candidates for elective total knee arthroplasty surgery (indication determined solely by the Orthopedic Surgeon)\n* Patients aged between 18 and 80 years (inclusive) for both groups\n* Body Mass Index (BMI) between 18 and 35 kg\u002Fm²\n* Willingness and ability to provide informed consent\n* Patients with non-inflammatory degenerative knee joint disease, including osteoarthritis\n\nExclusion Criteria:\n\n* Use of medications that may interfere with muscle metabolism\n* Bone metastases or diseases at the surgical site\n* Presence or suspicion of infection at the knee\n* Inability to provide informed consent\n* Obesity (BMI ≥ 35 kg\u002Fm²)\n* Patients requiring revision surgery of total knee arthroplasty\n* Patients with pacemakers and\u002For mechanical implants or those who may be affected by BIA interference","80 Years",{"count":211,"type":23},78,[26],"The purpose of this study is to evaluate the effectiveness of cryopressotherapy in patients undergoing total knee arthroplasty by assessing clinical improvement using the KOOS at 14 days after surgery.\n\nAnalysis of the knee Range of Motion (ROM) in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.\n\nAnalysis of PROMs such as: Oxford Knee Score (OKS), Joint Forgotten (JF), NRS score, and SF-12.\n\nThese questionnaires will be collected in the preoperative phase, at the predischarge visit, and at the follow-up visit for suture removal performed 14 days after surgery.\n\nTo evaluate whether cryopressotherapy leads to an improvement in predischarge hemoglobin (Hb) levels.\n\nTo assess whether cryopressotherapy reduces the circumference and subcutaneous fluid accumulation of the operated limb.",[215,216],"Total Knee Arthroplasty\\(TKA\\)","Osteoartrosi","2026-03-03",{"date":219,"type":34},"2026-03-06",{"date":221,"type":34},"2025-09-29",{"date":223,"type":23},"2028-02",{"name":40,"class":41},{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":235,"conditions":236,"keywords":241,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":42},"100622652","validation-and-cultural-adaptation-of-the-koos-acl-scale-for-the-italian-population-100622652","NCT07386405","Validation and Cultural Adaptation of the KOOS-ACL Scale for the Italian Population","Italian Version of KOOS-ACL (Knee Injury and Osteoarthritis Outcomes Score - Anterior Cruciate Ligament): Translation, Cross-cultural Adaptation and Validation","VACKP","Inclusion Criteria:\n\n* Patient age 18 years or older\n* Patients who are native Italian speakers\n* Patients undergoing anterior cruciate ligament reconstruction of the knee\n* Patients who have understood and signed the informed consent to participate in the study.\n* Patients who are able to understand the study conditions and participate for the entire duration\n\nExclusion Criteria:\n\n* Patients unable to understand the text in Italian\n* Patients undergoing knee replacement surgery, corrective osteotomies, or osteosynthesis of knee fractures.\n* Patients who are drug addicts, alcoholics, suffer from psychiatric disorders, or have any clinical conditions that could compromise the success of the questionnaire.\n* Patients with orthopedic conditions of other origins",{"count":234,"type":23},120,"Submission of the KOOS ACL questionnaires in Italian for the purpose of validation and cultural adaptation of the KOOS-ACL scale for the Italian population.",[237,238,239,240],"Scale Reliability Validity","ACL Injury","Validation and Cultural Adaptation of a Scale","PROMs",[242,243,244,240],"scale reliability","ACL","KOOS-ACL","2026-01-27",{"date":247,"type":34},"2026-02-04",{"date":249,"type":23},"2026-01-19",{"date":251,"type":23},"2027-07-01",{"name":40,"class":41},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":18,"sex":19,"minAge":261,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":42},"100620014","high-risk-coronary-atherosclerosis-in-subjects-with-family-history-of-myocardial-infarction-100620014","NCT07352111","High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction","High-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction; the FAMILY Study","FAMILY","Inclusion Criteria:\n\n* patients with postive family history of CAD\n\nExclusion Criteria:\n\n* known cardiovascular diseases\n* any symptoms","40 Years","70 Years",{"count":264,"type":23},200,[26],"The evidence of high-risk atherosclerosis at cardiac CT (CCT) may support aggressive primary prevention treatment, reducing the risk of future cardiovascular events. Family history of coronary artery disease (CAD) is a risk factor for cardiovascular events but limited data described the prevalence of coronary atherosclerosis in these patients.\n\nAims of the FAMILY project are to explore the prevalence of high-risk coronary atherosclerosis among patients with family history of CAD, to explore whether CCT in this setting may to reclassify patients' vs standard of care and to explore correlations between genetic background and high risk and potentially unstable coronary atherosclerosis.\n\nA consecutive cohort of asymptomatic of patients with family history of CAD will be prospectively enrolled. A per-protocol CCT with advanced atherosclerosis analysis will be performed. At the time of CCT a blood sample will be collected for bio-humoral and genetic investigation. The prevalence of high risk atherosclerosis will be quantified, the reclassification rate of CCT vs clinical evaluation evaluated and the potential in vivo association between genetic profile and high risk atherosclerosis explored.",[268],"Coronary Artery Diease",[270,271,272,273],"Cardiac CT","family history of CAD","atherosclerosis","primary prevention",{"date":275,"type":34},"2026-01-21",{"date":277,"type":34},"2025-12-03",{"date":279,"type":23},"2027-12-31",{"name":40,"class":41},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":18,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":42},"100618890","comparison-of-maglumi-x3-snibe-with-other-analytical-methods-in-laboratory-medicine-for-25-ohd-quantification-100618890","NCT07337499","Comparison of Maglumi X3 SNIBE With Other Analytical Methods in Laboratory Medicine for 25-(OH)D Quantification","Comparison of the Maglumi X3 SNIBE Method With Other Analytical Methods in Laboratory Medicine","Inclusion Criteria:\n\n* Healthy volunteer subjects:\n\nSubjects who sign the informed consent to participate in the study Age ≥ 18 years Employees, in various roles, of the IRCCS Galeazzi-Sant'Ambrogio Hospital\n\n-Patients:\n\nSubjects who sign the informed consent to participate in the study Age ≥ 18 years Patients referred for major orthopedic surgery: hip and knee replacement (bicompartmental and unicompartmental) Patients referred for cardiothoracic surgery\n\nExclusion Criteria:\n\n* Neoplastic diseases (until remission)\n* Grade I, II, and III obesity\n* Age \\\u003C 18 years\n* Women who are pregnant or breastfeeding, based on self-declaration\n* Individuals unable to understand and make decisions",{"count":264,"type":23},"The aim of this study is to assess the agreement among the results obtained using the Maglumi X3 SNIBE method and other analytical methods for the measurement of 25-(OH) vitamin D. The comparison between analytical methods is essential for evaluating the analytical performance of different measurement techniques. Assessing the level of comparability between measurements of the same analyte obtained using different methods is fundamental for the harmonization and quality of procedures used in laboratory medicine, ensuring a correct clinical interpretation of results.",[291],"Quantification of 25-(OH)D in Physiological Condition",[293,294,295,296],"25-(OH)D","vitamin D","analytical methods","immunoassay","2026-01-02",{"date":299,"type":34},"2026-01-13",{"date":301,"type":34},"2025-09-15",{"date":196,"type":23},{"name":40,"class":41},{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":42},"100616339","prepare-ii---predictive-model-training-and-external-validation-100616339","NCT07304323","Prepare II - Predictive Model Training and External Validation","Transforming Rehabilitation: Personalised Care for a Better Quality of Life (PREPARE, Phase 2)","Inclusion Criteria:\n\n* Patients admitted for THR and TKR at IRCCS Galeazzi Orthopedic Institute in 2018 (any month) and subsequently discharged to inpatient rehabilitation in the same structure.\n* Aged ≥18 years.\n* International Classification of Disease, Ninth Revision, Clinical Modification (ICD-9CM) Diagnoses: 715.15, 16, 25, 26 (primary and secondary osteoarthritis of the hip and knee).\n* ICD-9CM Surgical procedures: 81.51, 81.54 (total joint replacement of the hip and knee).\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years (if any).",{"count":312,"type":23},400,"The general aim of the project is training and testing a predictive model of inpatient rehabilitation stay after hip and knee replacement for osteoarthritis. This specific part focuses on data collection and analysis for the model validation.",[315],"HIP AND KNEE OSTEOARTHRITIS",[317,318,319,320,321,322],"total joint arthroplasty","osteoarthritis","total joint replacement","inpatient rehabilitation","predictive model","rehabilitation outcomes","2025-12-11",{"date":325,"type":34},"2025-12-26",{"date":327,"type":34},"2025-10-08",{"date":329,"type":23},"2026-10-31",{"name":40,"class":41},{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":19,"minAge":338,"maxAge":262,"enrollmentInfo":339,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":42},"100612172","3d-biomimetic-spine-unit-model-through-the-integration-of-bioprinting-and-transcriptomics-cdp-subt-100612172","NCT07250126","3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)","CDP-SUBT","Inclusion Criteria:\n\n* Signature of the Informed Consent for the study\n* Age 30-70 years (included)\n* Pfirrmann grade III-V\n* Need to undergo spinal surgery\n\nExclusion Criteria:\n\n* Presence of HIV, HBC, HCV or TPHA infection","30 Years",{"count":340,"type":23},5,"The general objective of this project is to define the transcriptional profile of primary human cells derived from the nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplate (CEP), and to use this information as a reference to assess the biological relevance of a biomimetic spinal unit model obtained through bioprinting. By developing an in vitro model of human origin that incorporates key components of the spinal unit and applying transcriptional analyses to both native cells and their counterparts recovered from the 3D construct, the study will evaluate how accurately the bioprinted model reproduces the identity and heterogeneity of the native discal environment.",[343],"Degenrative Disc Disease","2025-11-18",{"date":346,"type":34},"2025-11-26",{"date":348,"type":34},"2025-11-04",{"date":350,"type":23},"2027-10",{"name":40,"class":41},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":371,"locationsCount":42},"100605884","clinical-and-radiological-evaluation-of-total-ankle-replacement-protesitt-100605884","NCT07168330","Clinical and Radiological Evaluation of Total Ankle Replacement (ProtesiTT)","Clinical and Radiological Evaluation in Patients With Total Ankle Replacement","ProtesiTT","Inclusion Criteria:\n\n* patients treated with ankle replacement for osteoarthritis\n* The patient is willing and able to complete scheduled follow-up evaluations questionnaires and radiographic examination as described in the Informed Consent\n\nExclusion Criteria:\n\n* patients without radiographic follow-up","90 Years",{"count":130,"type":23},"Numerous studies reported the efficacy of new third-generation of total ankle arthroplasties for the treatment of advanced ankle osteoarthritis and clinical results are comparable to ankle arthrodesis. The improvement in knowledge of ankle joint biomechanics, instrumentation, surgical approach may led to even higher clinical results in comparison to arthrodesis.\n\nMany of the studies reporting the results of ankle replacement are provided by surgeons involved at least in the initial design of the implant. Thus, familiarity with the system can be a potential bias affecting outcomes and orthopedic surgeons may find difficulties in reproducing the results.\n\nIn this study, we will assess the clinical and radiological outcomes in patients who underwent this procedure performed by non-designer surgeons",[364],"Orthopedic Disorder","2025-09-11",{"date":367,"type":34},"2025-09-17",{"date":369,"type":34},"2017-07-01",{"date":279,"type":23},{"name":40,"class":41},{"id":373,"slug":374,"hasResults":12,"nctId":375,"briefTitle":376,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":18,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":381,"conditions":382,"keywords":385,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":42},"100315473","metabolic-profile-of-bone-in-professional-athletes-100315473","NCT03386981","Metabolic Profile of Bone in Professional Athletes","Study of the Metabolic Profile of Bone in Professional Athletes as a Function of the Kind of Physical Activity Performed","SportMarkers","Inclusion Criteria:\n\n* \\>\u002F= 18 yo\n* healthy status\n* caucasians\n\nExclusion Criteria:\n\n* \\\u003C 18 yo\n* pregnancy status\n* ongoing or previous (\\\u003C5 years) neoplasia\n* acute or chronic inflammatory pathologies\n* primary metabolic diseases of bone\n* recent bone fractures (\\\u003C 6 months)\n* chronic drugs\n* recent drugs administration (\\\u003C 2 months) for non steroidal anti-inflammatory drugs (NSAIDs) and steroids\n* anxious-depressive conditions\n* inability to understand the information given by the recruiting physician",{"count":264,"type":23},"Physical activity is a key stimulus for bone metabolism through both direct mechanisms (e.g., as a result of the applied load and\u002For impact) and indirect mechanisms (e.g., the activation of several metabolic pathways and the production of several mediators and effectors that have systemic effects). However, different kinds of physical activity exert different effects on bone and endocrine system.\n\nAim of the study is to investigate the effects of different kinds of physical activity on bone metabolism and on the relationships existing between bone metabolism, energy metabolism, hormone profile, and organ functionality.",[383,384],"Bone Disease, Metabolic","Physical Activity",[386,387,388],"Energy metabolism","Homeostasis","Bone turnover markers","2025-09-04",{"date":365,"type":34},{"date":392,"type":34},"2016-02-04",{"date":394,"type":23},"2027-02-04",{"name":40,"class":41},{"id":397,"slug":398,"hasResults":12,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":18,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":405,"conditions":406,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":42},"100594807","biological-waste-sample-collection-for-progress-in-oral-and-maxillofacial-research-100594807","NCT07024251","BIOlogical Waste Sample Collection for Progress in Oral and MAXillofacial Research","BIO-MAX","Inclusion Criteria:\n\n* males and females\n* ≥18 years old\n* patients undergoing either routine oral clinical examination or elective oral and maxillofacial surgery at IRCCS Ospedale Galeazzi - Sant'Ambrogio\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* inability to sign the Informed Consent\n* positivity to virological tests (HIV, HCV, HBV, TPHA), if serological analysis is required\n* pregnancy and breast feeding with declaration of patient",{"count":404,"type":23},383,"The BIO-MAX (BIOlogical waste sample collection for progress in oral and MAXillofacial research) study, led by IRCCS Ospedale Galeazzi-Sant'Ambrogio, is a five-year observational research project aimed at improving the understanding and treatment of oral and maxillofacial conditions.\n\nResearchers are collecting and analyzing biological samples-such as saliva, blood, and tissues typically discarded during dental and surgical procedures-from adult patients visiting the hospital for oral exams or surgery. A key focus is the study of salivary irisin, a promising biomarker linked to diseases like diabetes and heart disease. By examining how irisin levels vary with age, gender, lifestyle, and oral health, the team hopes to establish baseline values and better understand its diagnostic potential.\n\nIn addition to irisin analysis, the study will explore other waste tissues to uncover disease mechanisms, identify new biomarkers, and test future therapies using patient-derived laboratory models. Overall, BIO-MAX seeks to enhance diagnostics, improve patient care, and pave the way for innovative treatments in oral and maxillofacial medicine.",[407],"Oral and Maxillofacial Conditions","2025-06-12",{"date":410,"type":34},"2025-06-17",{"date":412,"type":34},"2025-05-16",{"date":414,"type":23},"2030-05",{"name":40,"class":41},{"id":417,"slug":418,"hasResults":12,"nctId":419,"briefTitle":420,"officialTitle":421,"acronym":4,"eligibilityCriteria":422,"healthyVolunteers":18,"sex":19,"minAge":423,"maxAge":4,"enrollmentInfo":424,"targetDuration":425,"studyType":54,"phases":4,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":4},"100588349","use-of-virtual-reality-for-the-assessment-of-attentional-and-reaction-abilities-for-fall-risk-evaluation-100588349","NCT06940245","Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation","Motor and Cognitive Abilities in Relation to Fall Risk: Use of Virtual Reality for the Assessment of Attentional and Reaction Capacities","Inclusion Criteria:\n\n* Male or female, of any ethnicity;\n* Age ≥ 60 years;\n* Cognitively intact;\n* Autonomous ambulation;\n* Signed and accepted informed consent to participate in all procedures required for the study.\n\nExclusion Criteria:\n\n* Body Mass Index \\> 40.0;\n* History of epileptic episodes;\n* Bone fractures in the last 6 months;\n* Previous surgical treatments for orthopedic conditions performed in the six months prior to study inclusion;\n* Use of medications that affect motor coordination, balance, and bone and muscle metabolism;\n* Conditions that, despite autonomous ambulation, influence fall risk (e.g., orthopedic, rheumatologic, or neurological conditions);\n* Carriers of pacemakers and mechanical implants.","60 Years",{"count":130,"type":23},"2 Weeks","Aging is a condition characterized by a general decline in physical and cognitive performance, however its effects on various functions are still controversial. These changes lead to an increased risk of injuries, particularly due to falls. According to the World Health Organization (WHO) report, 28-35% of individuals aged over 65 experience a fall each year, and this percentage increases with age. For this reason, preventing falls among the elderly is undeniably one of the most critical public health issues in today's aging society. Nowadays, it is widely demonstrated that the loss of muscle strength and mass, along with decreased balance, significantly increases the risk of falls. However, with aging, numerous other changes occur that contribute to an increased risk of falls, such as a decline in cognitive function, including attention, reaction capabilities and memory, as well as other factors that worsen the quality of life, such as insufficient sleep or nutrition. According to WHO estimates, by 2030, the number of injuries due to falls will double. Therefore, it is of great importance to understand and analyze the factors contributing to falls among older adults in everyday life. For this reason, the principal aim of this study was to evaluate the correlation between the fall index and the Visual Attention, Reaction Time and visual field using the technologies of Virtual Reality (VR). Since aging brigs changes in different aspect, the secondary objectives aim to study the correlation also with i) sleep quantity and quality parameters, ii) risk of malnutrition, and iii) physical condition, muscle conditions and strength in order to have a comprehensive understanding of the factors that most contribute to the risk of falls. In addition to these objectives, the correlation between acute sleep deprivation and the risk of falls will also be analyzed, in order to understand how inadequate sleep quantity can impact injuries in the elderly.",[428,429,430],"Aging","Fall Risk Factors","Sleep","2025-04-15",{"date":433,"type":34},"2025-04-23",{"date":435,"type":23},"2025-04-20",{"date":437,"type":23},"2027-07-30",{"name":40,"class":41},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":42},"100582671","evaluation-of-limb-function-and-perception-in-rehabilitation-after-traumatic-wrist-fracture-surgery-100582671","NCT06866340","Evaluation of Limb Function and Perception in Rehabilitation After Traumatic Wrist Fracture Surgery","Evaluation of the Functionality and Perception of the Injured Limb in the Rehabilitation Process of Orthopedic Patients Undergoing Surgical Treatment for Traumatic Wrist Fracture","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Patients who have undergone surgical treatment with a volar approach for a traumatic distal radius fracture at IRCCS Ospedale Galeazzi - Sant'Ambrogio.\n* Willingness and ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Pre-existing neurological, psychiatric, or cognitive disorders that could affect motor function or body perception.\n* Previous fractures of the same limb.\n* Pregnancy or breastfeeding (self-reported).",{"count":130,"type":23},"The goal of this observational study is to assess the functional and perceptual alterations of the affected limb during rehabilitation in adult orthopedic patients who underwent surgical treatment for distal radius fractures. The main questions it aims to answer are:\n\nWhat is the correlation between functional and perceptual alterations of the affected limb at the beginning and end of rehabilitation? How do these alterations influence rehabilitation duration and effectiveness?\n\nParticipants will:\n\nComplete the patient questionnaires ((QuickDASH and ALPQ). Undergo handgrip strength tests and digital dynamometer tests to assess forearm muscle strength.\n\nHave their range of motion evaluated by a physiotherapist during outpatient visits.\n\nNo additional diagnostic or instrumental examinations are required beyond routine clinical practice. The study will recruit 100 adult patients, last 24 months, and provide insights into the role of body perception in rehabilitation after wrist fractures.",[449,450,451],"Distal Radius Fractures","Rehabilitation","Body Perception",{"date":453,"type":34},"2025-04-18",{"date":455,"type":23},"2025-05-01",{"date":457,"type":23},"2027-02",{"name":40,"class":41},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":467,"targetDuration":469,"studyType":54,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":42},"100585851","splintless-virtual-surgical-plan-with-mandible-first-technique-3d-accuracy-analysis-100585851","NCT06907745","Splintless Virtual Surgical Plan with Mandible-first Technique: 3D Accuracy Analysis","Splintless Virtual Surgical Plan with Mandible-first Technique in Orthognathic Surgery: Tridimensional Accuracy Analysis","MandiFirst","Inclusion Criteria:\n\n* Men and women\n* Age over 18 and under 60\n* Diagnosis of dento-skeletal dysmorphosis involving the middle third and lower part of the face\n* Patients with consent to surgery\n* Patients in good general health according to the evaluation of the PI and on the basis of the anamnesis and clinical examination\n\nExclusion Criteria:\n\n* History of previous maxillomandibular fracture\n* Treatment with anticoagulant drugs\n* Treatment with intravenous bisphosphonates\n* Treatment with anticonvulsants\n* Patient's inability to maintain home hygiene standards in accordance with the study requirements\n* History of drug and\u002For alcohol abuse\n* Chronic corticosteroid therapy\n* Radiotherapy, chemotherapy and\u002For immunosuppressive treatment or radiotherapy in the last 5 years\n* Psychosis\n* Pregnant or breastfeeding\n* Poor compliance\n* Endocrinological disorders in poor pharmacological control\n* Other uncontrolled systemic conditions that preclude performing surgical procedures",{"count":468,"type":23},28,"6 Months","Accuracy assessment through three-dimensional superposition of the post-operative volumetric CT and the digital therapeutic project files.",[472],"Dentofacial Deformities","2025-03-26",{"date":475,"type":34},"2025-04-02",{"date":477,"type":34},"2024-04-24",{"date":479,"type":23},"2025-12-31",{"name":40,"class":41},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":18,"sex":19,"minAge":51,"maxAge":489,"enrollmentInfo":490,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":492,"conditions":493,"keywords":496,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":502,"lastUpdatePostDateStruct":503,"startDateStruct":505,"completionDateStruct":507,"leadSponsor":509,"locationsCount":42},"100573497","gender-impact-on-physical-activity-in-chronic-musculoskeletal-disorders-prevention-100573497","NCT06747052","Gender Impact On Physical Activity In Chronic Musculoskeletal Disorders Prevention","Gender Impact On Physical Activity In Chronic Musculoskeletal Disorders Prevention: A Survey-based Cross-sectional Study in Regione Lombardia","Move4Health","Inclusion Criteria:\n\n* Adults with age range between 18 and 64 years, residents in Region Lombardia and spoken\u002Freader Italian language\n\nExclusion Criteria:\n\n* People with less than 18 years of age or more than 64 years of age. No other exclusion criteria will be applied.","64 Years",{"count":491,"type":23},1310,"The goal of this survey based cross-sectional survey is to understand if there are gender patterns in physical activity participation and how they are associated with gendered organization of work and family activities, identifying socio-environmental variables that hamper the participation of both females and males in an active and healthy lifestyle. This survey also aim to explore if awareness and beliefs regarding musculoskeletal disorders and physical activity as factor for prevention differ according to gender and sex.\n\nThe main question is to investigate gender differences in physical activities participation in terms of adherence or not adherence to WHO recommendations by adjusting for socio-environmental variables.\n\nThe secondary questions are:\n\n* To explore impact of gender on health status and sedentary behavior at same adherence and intensity level of physical activity\n* To explore whether awareness and beliefs on musculoskeletal disorders and physical activity as prevention factor in the general population differ according to gender and sex.",[384,494,495],"Musculoskeletal Disease","Gender Equity",[497,498,499,495,500,501],"Physical activity","Gender","Musculoskeletal","Surveys and Questionnaires","Cross-Sectional Studies","2025-03-04",{"date":504,"type":34},"2025-03-05",{"date":506,"type":34},"2025-02-24",{"date":508,"type":23},"2026-02-15",{"name":40,"class":41},{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":19,"minAge":517,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":524,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":531},"100417120","clinical-and-biomolecular-assessment-for-the-monitoring-of-patients-undergoing-regenerative-medicine-treatments-with-orthobiologics-100417120","NCT04711551","Clinical and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics","Patients-reported Outcome Measures (PROMs), Clinical Objective and Biomolecular Assessment for the Monitoring of Patients Undergoing Regenerative Medicine Treatments with Orthobiologics","Inclusion Criteria:\n\n* patients who received indication for regerative medicine treatment for one of the following pathologies: Knee or hip or ankle osteoarthritis, patellar or Achilles tendon pain, shouder or elbow pain;\n* males and females;\n* age \\>= 6 years.\n\nExclusion Criteria:\n\n* age \\\u003C 6 years\n* patients not compliant with post-treatment monitoring procedures\n* pregnancy","6 Years",{"count":519,"type":23},2000,"the aim is to improve the evaluation of the outcomes of regenerative medicine treatments performed in the regenerative medicine centers involved in the study.\n\npatients who undergo regenerative medicine treatments present acute and chronic pathologies of the musculoskeletal system, of the stomatological system and of the integuments.\n\nObjective pre, peri and post treatment evaluations are collected. A dedicated software collects the PROMs compiled by the patients, the objective clinical data and the biomolecular evaluations.",[522],"Musculoskeletal System Disease","2025-02-13",{"date":525,"type":34},"2025-02-17",{"date":527,"type":34},"2018-05-30",{"date":529,"type":23},"2030-05-30",{"name":40,"class":41},2,{"id":533,"slug":534,"hasResults":12,"nctId":535,"briefTitle":536,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":542,"conditions":543,"keywords":545,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":523,"lastUpdatePostDateStruct":549,"startDateStruct":550,"completionDateStruct":552,"leadSponsor":553,"locationsCount":531},"100301743","banca-di-materiale-biologico-per-lo-studio-di-patologie-che-interessano-lapparato-muscolo-scheletrico-100301743","NCT03208062","Banca di Materiale Biologico Per lo Studio di Patologie Che Interessano l'Apparato Muscolo-scheletrico","Costituzione di Una Banca di Materiale Biologico da Paziente (Biobanca) Per lo Studio di Patologie Che Interessano l'Apparato Muscolo-scheletrico","BioBanca","Inclusion Criteria:\n\n* Patients admitted to our Institute\n* Patients aged ≥18 years\n* Patients with osteoarthritis of hip or knee and rehabilitated in the institute\n* Patients with primary and secondary tumors of the skeleton\n* Patients undergoing prosthetic surgery following infection of the implant\n\nExclusion Criteria:\n\n* Participants aged \\\u003C18 years\n* Participants unable to release the Informed Consent",{"count":541,"type":23},1500,"Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the major causes of disability. Considering the importance of studying these pathologies, it is necessary to develop research lines based on the availability of human biological material from highly clinically relevant patients. The purpose of this project is therefore the establishment of a bank of biological material (biobank) to investigate important aspects related to the pathologies of the musculoskeletal system through subsequent bio-molecular characterization studies.",[544],"Tissue Banking",[546,547,548],"Biobank","Waste material","Orthopaedic",{"date":525,"type":34},{"date":551,"type":34},"2017-05-31",{"date":151,"type":23},{"name":40,"class":41},{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":561,"targetDuration":469,"studyType":54,"phases":4,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":579},"100577164","stratifying-adult-diffuse-lower-grade-gliomas-based-on-their-varied-metabolic-profiles-stradivari-project-100577164","NCT06794736","STRatifying Adult DIffuse Lower-grade Gliomas Based on Their VARIed Metabolic Profiles (STRADIVARI Project)","STRADIVARI","Prospective Metabolic Cohort:\n\nInclusion Criteria:\n\n* Radiological diagnosis of brain tumor compatible with lower grade glioma\n* Full clinical history\n\nExclusion Criteria:\n\n* Current pregnancy or lactation\n* Patients not able to provide informed consent\n\nRetrospective Cohort of FFPE samples:\n\nInclusion Criteria:\n\n* Confirmed diagnosis of lower grade glioma\n* Full clinical and radiological history",{"count":562,"type":23},110,"The goal of this observational study is to better characterise lower-grade gliomas from a molecular and metabolic point of view, so to identify further subgroups of these tumours with different behaviour and, possibly, different treatment susceptibility.\n\nParticipants of prospective metabolic cohort will be subjected to routine treatment, part of the exceeding tutor material will be subjected to advanced molecular-metabolic analyses to desume their metabolic profile to be then correlated with clinical outcome (progression-free survival, overall survival, response to therapy\u002Fprogression) and diagnosis (astrocytoma\u002Foligodendroglioma and grade).\n\nCritical enzymes identified from metabolic analyses on the first cohort will be tested on a protein level on a retrospective cohort of patients previously operated and for whom fully available clinical history and pathological material is available in Institutional archive (no need for further intervention on these patients) to see if they actually correlate with clinical outcome.",[565],"Lower Grade Glioma",[567,568,569,570],"Lower grade glioma","Metabolomics","Tumor heterogeneity","Patient Stratification","2025-01-22",{"date":573,"type":34},"2025-01-27",{"date":575,"type":34},"2024-11-14",{"date":577,"type":23},"2026-08",{"name":40,"class":41},4,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":19,"minAge":588,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":24,"phases":591,"briefSummary":593,"conditions":594,"keywords":597,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":606,"lastUpdatePostDateStruct":607,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":42},"100575131","phase-2-baricitinib-in-cppd---the-baptist-study-100575131","NCT06768294","Baricitinib in CPPD - the BAPTIST Study","Baricitinib in Calcium PyrophosphAte DePosiTion DIseaSe Trial - a Proof of Concept Phase II Clinical Trial","BAPTIST","Inclusion Criteria:\n\n* Signed Informed Consent;\n* Male and female patients aged ≥55 years;\n* Patients that according to the investigator's judgement will benefit from the proposed treatments (favourable benefit\u002Frisk profile)\n* Menopause for women;(no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a high follicle stimulating single measurement is insufficient.);\n* Male patients must avoid having a child during the trial and must use one of the highly effective methods of contraception or sexual abstinence or have a menopause partner (no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a high follicle stimulating single measurement is insufficient). Contraception methods include:\n\n  * Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n  * Sterilization of the female partner (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least six weeks before the partner enrollment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment\n  * Male sterilization (vasectomy) at least 6 months prior to screening\n  * Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical\u002Fvault caps).\n  * The female partner use oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS)\n* Patients fulfilling the 2023 ACR\u002FEULAR classification criteria for CPPD disease;\n* Patients with feasibility of synovial biopsy at the knee or wrist joint;\n* Patients with CPPD clinical presentation that may be:\n\n  * Subset 1: patients with prevalent polyarticular involvement of the small joints and tendons of hands and wrists (rheumatoid-like subset). Patients that present with prevalent inflammatory involvement of the hands and wrists (joints and\u002For tendons), with or without acute attacks of arthritis of the large joints, will be included in this group. Inclusion criteria will be joint effusion and\u002For synovitis of the II and\u002For III metacarpal phalangeal (MCP) joint of at least one hand, tenosynovitis of at least 1 tendon of one hand or wrist, hyperostosis of the II and\u002For III MCP head;\n  * Subset 2: patients with prevalent involvement of the large joints (oligoarthritis). Patients with recurrent\u002Fpersistent effusion in one or more large joints (independently of the presence and grade of OA), not responsive to a single injection of steroid and white cell count in joint synovial fluid that is more than 2000 cells\u002Fmm3 and\u002For patients with acute monoarticular arthritis, with more than 3 attacks in one joint in the last 12 months, will be included in this group.\n\nExclusion Criteria:\n\n* Patients positive at anticitrullinated positive antibodies (ACPA), any titre;\n\n  * Patients affected by seronegative arthritis or other conditions that may be responsible of arthritis (i.e. gout, rheumatic polymyalgia, etc);\n  * Patients that refuse synovial biopsy or present contraindications, according to investigator's judgement, including (but not limited to) increased risk for bleeding (platelet count \\<100000 or use of anticoagulants), allergy to local anesthetics, suspicion of septic arthritis;\n  * Patients with history of malignancy or lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \\< 5 years;\n  * Patients with cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinomas who have had active disease within 3 years of screening for this study;\n  * Patients with active, untreated, acute or chronic infection (such as untreated tuberculosis), or immunocompromised to an extent that such that participation in the study would pose an unacceptable risk to the subject. Patients with treated infections such as latent tuberculosis after completion of the appropriate therapy are not excluded;\n  * Patients with clinically serious infection or that have received intravenous antibiotics for an infection, within 4 weeks of randomization;\n  * Patients with active viral infection that, based on the investigator\\'s clinical assessment, makes the patient an unsuitable candidate for the study;\n  * Patients with serology suggestive for active or chronic hepatitis B or hepatitis C infection; anti-HCV, anti-HBs, anti-HBc antibodies and HBcAg, HBsAg will be tested. Patients that will result positive for anti-HCV and\u002For HBcAg and\u002For HBsAg and\u002For anti-HBc antibodies will be excluded from the study. Patients who are positive for both anti-HBc and antiHBs, but negative for HBcAg and HBsAb could be enrolled.\n  * Patients with symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster;\n  * Patients with a history of disseminated opportunistic infections (e.g., listeriosis and histoplasmosis);\n  * Patients with a history of venous thromboembolism (VTE), or are considered at high risk for VTE as deemed by the investigator\n  * Patients who are currently on immunosuppressive therapies or have not discontinued them for at least 4 weeks;\n  * Patients with clinically significant (per investigator\\'s judgement) drug or alcohol abuse within the last 6 months preceding the baseline visit;\n  * Patients with any major surgery within 8 weeks prior to baseline or requiring major surgery during the study, which in the opinion of the investigator would pose an unacceptable risk to the patient;\n  * Patients with recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting and uncontrolled hypertension (confirmed systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mm Hg); patients with less recent major cardiovascular events (\\> 6 months) will be thoroughly assessed for cardiovascular risk taking under consideration all possible risk factors and the disease phenotype and activity and will be included only in case of favourable benefit\u002Frisk ratio according to the principal investigators judgement.\n  * Patients with presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the patient if participating in the study or of interfering with the interpretation of the data;\n  * Patients with clinical laboratory test results at screening that are outside the normal reference range of the population and are considered clinically significant, or have any of the following specific abnormalities: neutrophil count \\<1500 cells\u002FµL, lymphocyte count \\<500 cells\u002FµL, platelet count \\<100,000 cells\u002FµL, aspartate transaminase (AST) or alanine aminotransferase (ALT) \\> 2 times the upper limit of normal, haemoglobin \\<10 g\u002FdL for male and female subjects, eGFR \\< 30 mL\u002Fmin;\n  * Patients with any other condition that precludes him\u002Fher from following and completing the protocol, in the opinion of the investigator;\n  * Patients currently enrolled in or discontinued from a clinical trial involving an investigational product or non-approved use of a drug or device within the last 4 weeks or a period of at least 5 half-lives of the last administration of the drug, whichever is longer, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.\n  * Hypersensitivity to the active substance or to any of the excipients","55 Years",{"count":590,"type":23},32,[592],"PHASE2","The aim of this clinical trial is to determine if baricitinib is effective in treating calcium pyrophosphate deposition disease (CPPD) in adults. The primary objective is to assess its impact on joint inflammation. The key questions the study seeks to answer are:\n\n* Can baricitinib reduce inflammation in affected joints?\n* Will baricitinib lead to changes in ultrasound findings, such as calcium crystal deposition and synovitis?\n\nResearchers will compare baricitinib to other treatments, including methylprednisolone, colchicine, hydroxychloroquine, and methotrexate with folic acid, for managing CPPD.",[595,596],"Calcium Pyrophosphate Deposition Disease","Chondrocalcinosis",[598,599,600,601,602,603,604,605],"calcium pyrophosphate deposition disease","chondrocalcinosis","pseudogout","ultrasound","baricitinib","olumiant","synovial biopsy","arthritis","2025-01-06",{"date":608,"type":34},"2025-01-10",{"date":610,"type":23},"2025-01",{"date":612,"type":23},"2027-01",{"name":40,"class":41},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":620,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":19,"minAge":51,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":624,"conditions":625,"keywords":627,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":42},"100573496","cannabis-extract-in-fibromyalgia-syndrome---the-sunrise-study-100573496","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",{"count":623,"type":23},38,"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.",[626],"Fibromyalgia (FM)",[628,629,630,631,632,633],"fibromyalgia","cannabis","pain","fatigue","quality of life","sleep disturbances","2024-12-18",{"date":636,"type":34},"2024-12-24",{"date":638,"type":34},"2024-12-05",{"date":640,"type":23},"2025-12",{"name":40,"class":41},""]