[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Azienda Ospedaliero-Universitaria Careggi\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":452},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,67,96,129,156,179,207,233,257,278,313,340,362,389,419],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100645390","derivation-and-validation-of-the-fungal-pneumonia-assessment-and-likelihood-predictor-score-100645390",false,"NCT07681583","Derivation and Validation of the Fungal Pneumonia Assessment and Likelihood Predictor Score","FUNGAL-P","Inclusion Criteria:\n\n* Age ≥18 years and ≤90 years.\n* Presentation to the Emergency Department or hospital with pneumonia.\n* Pneumonia defined according to IDSA\u002FATS criteria as the presence of at least two clinical signs or symptoms of lower respiratory tract infection (temperature \\\u003C36.0°C or \\>38.0°C, respiratory rate \\>20 breaths\u002Fmin, oxygen saturation \\\u003C90% on room air, arterial PaO₂ \\\u003C60 mmHg, cough, sputum production, white blood cell count \\\u003C4,000\u002FμL or \\>10,000\u002FμL, or bandemia \\>10%) together with radiographic evidence of a new pulmonary infiltrate or cavitary lesion.\n* Bronchoalveolar lavage (BAL), bronchial aspirate (BAS), or endotracheal aspirate (ETA) performed within 48 hours of hospital presentation.\n* Modified Rankin Scale score \\\u003C5.\n* Availability of microbiological investigations for identification of fungal, bacterial, or viral pathogens.\n* Provision of informed consent, when required by applicable regulations and ethics committee approval.\n\nExclusion Criteria:\n\n* Refusal or withdrawal of informed consent.\n* Age \\\u003C18 years or \\>90 years.\n* Pregnancy.\n* Expected life expectancy \\\u003C3 months.\n* Hospital-acquired pneumonia with onset \\>48 hours after hospital admission.\n* Modified Rankin Scale score ≥5.\n* Absence of microbiological diagnostic evaluation.\n* No identified bacterial, fungal, or viral pathogen after microbiological investigations.","ALL","18 Years","90 Years",{"count":20,"type":21},400,"ESTIMATED","30 Days","OBSERVATIONAL","The FUNGAL-P study is a single-center observational study designed to derive and validate a clinical prediction score for the early identification of fungal pneumonia in adult patients presenting with pneumonia.\n\nThe study includes a retrospective derivation cohort and a prospective validation cohort of patients undergoing microbiological evaluation of lower respiratory tract samples. Clinical, laboratory, radiological, microbiological, and treatment-related variables associated with fungal pneumonia will be analyzed to identify independent predictors of fungal infection. These predictors will be combined to develop the FUNGAL-P score.\n\nThe derived score will subsequently be evaluated in a prospective validation cohort to assess its diagnostic performance, calibration, and clinical utility. The ultimate goal is to facilitate earlier recognition of fungal pneumonia and support timely diagnostic testing and antifungal treatment in patients presenting to the Emergency Department or hospital with pneumonia.",[26,27,28,29,30,31,32,33,34,35],"Pneumonia","Fungal Pneumonia","Aspergillosis Pneumonia","Pulmonary Aspergillosis","Pulmonary Aspergillosis Invasive","Pneumocystis","Pneumocystis Pneumonia","Fungal Disease","Fungal Infection","Fungal Infection Lungs",[27,37,29,38,32,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53],"Aspergillus","Pneumocystis jirovecii","Coinfection","Community-Acquired Pneumonia","CAP","Risk Prediction","Clinical Prediction Rule","Clinical Risk Score","FUNGAL-P Score","SCORE","Bronchoalveolar Lavage","Emergency Department","Internal medicine","Infectious disease","Diagnostic Accuracy","Risk Factors","Respiratory Infection","RECRUITING","2026-06-26",{"date":57,"type":58},"2026-07-02","ACTUAL",{"date":60,"type":58},"2025-11-13",{"date":62,"type":21},"2031-11-13",{"name":64,"class":65},"Azienda Ospedaliero-Universitaria Careggi","OTHER",1,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":66},"100615703","endobronchial-valve-in-tubercular-and-ntm-pulmonary-cavities-100615703","NCT07296055","Endobronchial Valve in Tubercular and NTM Pulmonary Cavities.","Evaluating the Utility of Endobronchial Valves in the Management of Tubercular and NTM (Non Tubercolar Micobacteriosis) Pulmonary Cavities","TBET","Inclusion Criteria:\n\n1. Age between 18 and 80 years AND\n2. Patient with cavities deemed unsuitable for surgery (when an extensive pulmonary parenchymal damage due to TB, is present, making patients inappropriate for open thoracic surgery) AND\n3. To have signed the informed consent\n\n   AND one of the following conditions:\n4. Pulmonary MDR\u002FXDR -TB or NTM (difficult to treat or resistant to treatment) confirmed by smear samples and antibiogram or with persistence of positivity for Mycobacterium of the smear after standard pharmacotherapy and severe destruction of the lungs with 1 or more persistent cavities.\n5. Pulmonary TB or NTM with cavities and associated systemic diseases such as pancreatic diabetes, stomach and duodenum ulcer, liver and kidney diseases, HIV or another such disease that compromises pharmacological treatment.\n6. Recurrent haemoptysis attributable to TB or NTM\n\nExclusion Criteria:\n\n1. Contraindication to performance of bronchoscopy\n2. Severe cardiac comorbidities\n3. Severe psychiatric disorders\n4. Functional or anatomical pneumonectomy\n5. Asthma\n6. Pregnancy\n7. Patients for whom bronchoscopic procedures are contraindicated\n8. Patients with known allergies to Nitinol (nickel-titanium) or its constituent metals (nickel or titanium)\n9. Patients with known allergies to silicone\n10. Patients who have not quit smoking\n11. Patients with large bullae encompassing greater than 30% of either lung\n12. Patients with active pulmonary infection","80 Years",{"count":77,"type":21},30,"INTERVENTIONAL",[80],"NA","Tuberculosis (TB) is a complex disease in which the lungs are the primary site of infection. Infection is acquired through inhalation of droplet nuclei laden with Mycobacterium bacilli (M. tuberculosis) that settle in the alveoli as the primary focus. TB is characterized by a gradual expansion of infection and cavitation that causes progressive tissue destruction. Furthermore, the increase in drug-resistant forms of TB, including multidrug resistance (MDR) and pre-extensively drug-resistant TB (XDR), is becoming increasingly concerning. Treatment of pharmacosensitive diseases involves a duration of no less than 6 months, while that of MDR-TB and XDR-TB are even longer; generally well above 24 months. Nontuberculous mycobacteria (NTMs), or atypical mycobacteria, are organisms that cause various diseases such as skin and soft tissue infections, lymphadenitis, lung infections, disseminated infections, and a wide range of more rarely encountered infections that do not differ from tuberculosis in anatomy and radiologically even though they usually do not develop the primary complex. Given that the treatment success rate is unsatisfactory, there is an urgent need for new drugs and additional interventions to improve outcomes, both in patients with MDR\u002FXDR-TB and in patients with difficult-to-treat NTM.\n\nOne-way endobronchial valves (EBVs) have been used as an effective lung volume reduction strategy in emphysema without significant adverse events. The mechanism consists in inducing atelectasis, that is, creating a poorly ventilated environment with reduced oxygen tension. This reduced oxygen tension is unfavorable for the survival and proliferation of mycobacteria. Therefore, using these devices to treat cavities caused by multidrug-resistant mycobacteria or in patients not eligible for surgical therapy should reduce or completely heal the cavity, creating an inhospitable environment for the bacteria, slowing or eliminating their growth.\n\nCondition\u002Fdisease: Pulmonary MDR\u002FXDR-TB or NTM (difficult to treat or resistant to treatment) Number of patients to be enrolled: 30 It is a single-center, randomized, controlled, open-label, two-arm study.",[83,84],"Multidrug Resistance Tubercolosis","Non Tubercolar Micobacteriosis",[86,84,83],"Endobronchial valves","NOT_YET_RECRUITING","2025-12-18",{"date":90,"type":58},"2025-12-22",{"date":92,"type":21},"2026-01-12",{"date":94,"type":21},"2028-12-12",{"name":64,"class":65},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":104,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":78,"phases":107,"briefSummary":108,"conditions":109,"keywords":112,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":66},"100598810","microbiota-inflammation-brain-axis-in-heart-failure-new-functional-food-for-the-prevention-of-undernutrition-in-older-100598810","NCT07076329","Microbiota-Inflammation-Brain Axis in Heart Failure: New Functional Food for the Prevention of undeRnutrition in Older","Microbiota-Inflammation-Brain Axis in Heart Failure: New Food, biomarkerS and Artificial Intelligence Approach for the Prevention of undeRnutrition in Older","AMBROSIA","Inclusion Criteria:\n\n* Age \\>70 years;\n* Caucasian ethnicity;\n* Diagnosis of atrial fibrillation (AF) and\u002For heart failure (HF);\n* Normal nutritional status or at risk of malnutrition;\n* Adherence to Mediterranean diet\n\nExclusion Criteria:\n\n* Obesity (BMI \\>30 Kg\u002Fm2);\n* Underweight (BMI \\\u003C18.5 Kg\u002Fm2);\n* Use of antibiotics, corticosteroids and immune-suppressors in the last 6 months;\n* Immunodeficiency;\n* Trip to exotic areas in the last 12 months;\n* Recent (\\\u003C3 months) major surgical procedure;\n* Uncontrolled diabetes mellitus;\n* Active cancer;\n* Chronic significant hepatic diseases;\n* Chronic renal failure (KDIGO stages 4-5);\n* Dementia and severe mental diseases;\n* Other conditions interfering with autonomous drugs assumption;\n* Chronic use of NSAIDs;\n* Relevant history of allergy or infectious diseases","70 Years",{"count":106,"type":21},60,[80],"The goal of this clinical trial is to learn if the AMBROSIA Bar helps prevent undernutrition and muscle loss in older adults with heart failure or atrial fibrillation.\n\nThe main questions it aims to answer are:\n\nDoes the AMBROSIA Bar help improve muscle mass and physical performance in older adults with heart conditions? What effects does the AMBROSIA Bar have on body composition, quality of life, inflammation, nutrition status, and gut microbiota?\n\nResearchers will compare people who assume the AMBROSIA Bar in addition to nutritional counseling to those who only receive nutritional counseling.\n\nParticipants will:\n\n* Receive nutritional counseling and consume one AMBROSIA Bar per day for 6 months (intervention group) or receive nutritional counseling only (control group).\n* Receive clinical assessment at the moment of enrolment, after 3 months, and after 6 months\n* Give samples (blood, saliva, urine, and stool) and complete questionnaires to check their nutrition, cognitive, and physical health",[110,111],"Atrial Fibrillation (AF)","Heart Failure",[113,114,115,116,117,118,119,120],"gut microbiota","elderly","probiotics","functional food","frailty","inflammation","heart failure","atrial fibrillation","2025-07-29",{"date":123,"type":58},"2025-07-31",{"date":125,"type":58},"2022-02-07",{"date":127,"type":21},"2025-09-30",{"name":64,"class":65},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":78,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":66},"100593395","phase-2-hormonal-receptor-hr-positive-her2-negative-breast-cancer-patients-treated-with-preoperative-elacestrant-and-pulsar-radiotherapy-100593395","NCT07005882","Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Radiotherapy","Hormonal Receptor (HR)-Positive HER2 Negative Breast Cancer Patients Treated With Preoperative ELacestrant and PULSAR Adaptive Radiotherapy: a Phase II Study (HELP Trial)","HELP","Inclusion Criteria:\n\n1. Histologically proven HR-positive, HER2-negative BC\n2. Clinical disease stage II-III\n3. Post-menopausal female patients or male patients\n4. Eligible for neoadjuvant treatment and subsequent surgery\n5. No contraindication to MRI\n6. Patient able to understand and follow instructions during the trial\n7. Patient able and willing to give written informed consent, signed and dated\n8. Patient aged at least 50 years old\n9. Patient with tumor accessible for biopsy and surgery\n10. Patient with adequate bone marrow function at Screening, confirmed at Baseline, including:\n\n    1. ANC ≥ 1.5 × 109\u002FL; patients with documented benign cyclical neutropenia are eligible if white blood cell count is ≥ 1.5 × 109\u002FL, with ANC ≥ 1.0 × 109\u002FL, leukocytes ≥ 4.0 × 109\u002FL, and lymphocytes ≥ 0.6 × 109\u002FL;\n    2. platelets ≥ 100 × 109\u002FL;\n    3. hemoglobin ≥ 9 g\u002FdL (may have been transfused);\n11. International Normalized Ratio (INR) \\\u003C 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR \\\u003C 3\n12. Patient with adequate hepatic function at Screening, confirmed at Baseline, defined by:\n\n    a. total bilirubin level ≤1.5×ULN; patients with documented Gilbert disease are allowed if total bilirubin ≤3×ULN; aspartate aminotransferase (AST) level ≤2.5×ULN, and alanine aminotransferase (ALT) level ≤2.5×ULN,\n13. Patient with adequate renal function at Screening, confirmed at Baseline, defined by eGFR ≥ 30 mL\u002Fmin using 2021 CKD-EPI creatinine equation\n14. Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n15. Life expectancy of at least 12 months according to the Investigator's judgement\n\nExclusion Criteria:\n\n* 1\\. Patients with stage IV disease 2. Patients with a history of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator's judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of RT and\u002For Elacestrant or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications.\n\n  3\\. Patients with any significant co-morbidity which, according to the Investigator's judgement, makes patient compliance to trial conditions unlikely.\n\n  4\\. Patients with previous malignant disease (other than the tumor disease for this trial) within the last five (5) years (except adequately treated non-melanoma skin cancers and carcinoma in situ of skin, bladder, cervix, colon\u002Frectum, breast, or prostate) unless a complete remission without further recurrence was achieved at least two (2) years prior to Screening, and the patient is deemed to have been cured with no additional therapy required or anticipated to be required.\n\n  5\\. Patients with a history of uncontrolled intercurrent illness. 6. Patients with a known prior hypersensitivity or contraindications to Elacestrant or any component in its formulations.\n\n  7\\. Patients with severe acute or chronic medical conditions, including:\n  1. Immune colitis\n  2. Inflammatory bowel disease\n  3. History of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline\n  4. Immune pneumonitis\n  5. Pulmonary fibrosis\n  6. Psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior\n  7. Laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial.\n\n     8\\. Patients with a history of small intestine resection surgery or other major gastrointestinal surgery.\n\n     9\\. Patients with an active infection requiring systemic therapy with antibiotics (at both Screening and Baseline).\n\n     10\\. Patients with a known history of human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome or multi-drug-resistant gram-negative bacteria.\n\n     11\\. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive).\n\n     12\\. Patients with increased anesthesiological risk (e.g. known or predicted difficult airway) if general anesthetic is required.\n\n     13\\. Premenopausal patients (defined as any woman who is not surgically sterile with a hysterectomy and\u002For bilateral oophorectomy or \\>12 months of amenorrhea and at least 50 years of age) 14. Patients aged less than 50 years old. 15. Patients with a known history of drug\u002Fsubstance abuse. 16. Patients participating in any other clinical trial within 30 days before Screening.\n\n     17\\. Patients receiving any other treatment that, in the opinion of the Investigator, might interfere with the trial.\n\n     18\\. Concomitant use of strong or moderate CYP3A4 inhibitors should be avoided and an alternative concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered.\n\n     19\\. Concomitant use of strong or moderate CYP3A4 inducers should be avoided and an alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered.\n\n     20\\. Patients with a current drug or substance abuse. 21. Patients receiving chronic concurrent therapy within two (2) weeks before the trial treatment or expected therapy during the trial treatment period with:\n\n  \u003C!-- -->\n\n  1. Corticosteroids (except systemic corticosteroids up to 10 mg prednisolone or equivalent daily dose).\n  2. Immunosuppressive agents.\n  3. Antibiotics.\n  4. Any other anticancer therapy or concurrent anticancer treatment. 22. Patients who are unable to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial.\n\n     23\\. Patients who are unlikely to comply with the Protocol requirements, instructions and trial-related restrictions, e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial.\n\n     24\\. Patients with legal incapacity or limited legal capacity. 25. Patients with any condition which results in an undue risk for the patient during the trial participation according to the Investigator.","50 Years",{"count":139,"type":21},21,[141],"PHASE2","This is a proof-of-concept phase II trial to assess the safety (as primary endpoint) and clinical efficacy of neoadjuvant therapy with Elacestrant and PULSAR.\n\nThe study will enroll 21 postmenopausal patients with early HR+ HER2- node positive BC, clinically staged II-III. Patients will receive Elacestrant 345 mg orally once daily for 24 weeks and PULSAR on the MRI-based breast gross tumor volume (GTVt), consisting of 10 Gy \"pulse\" every 4 weeks for a maximum of 5 or less in case of radiologic complete response.\n\nSurgery will be planned 24 weeks after Elacestrant initiation and at least 2 weeks from the last pulse and will be performed as per recommended clinical practice. Patients will then receive adjuvant systemic therapy as per standard of care and postoperative RT to the locoregional lymph nodes in case of nodal residual disease, if indicated.",[144,145,146,147],"Breast Cancer Patients","Breast Cancer Early Stage Breast Cancer (Stage 1-3)","HR+\u002FHER2- Breast Cancer","Radiation Therapy","2025-06-03",{"date":150,"type":58},"2025-06-05",{"date":152,"type":21},"2025-09-01",{"date":154,"type":21},"2028-03-01",{"name":64,"class":65},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":66},"100592591","discontinuation-of-tobacco-dependence-in-smoking-patients-with-squamous-cell-carcinoma-of-the-head-neck-district-multicenter-prospective-observational-study-100592591","NCT06995417","Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study","STOP-HNC","Inclusion criteria.\n\n* Patients with SCCHN tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses.\n* Patients older than 18 years of age with SCCHN of these sites who are candidates for surgical\u002Fradiotherapy (RT)\u002Fradiochemotherapy (RTCT) treatment with curative intent (primary treatment).\n* Patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer\n\nExclusion criteria\n\n* Patients with SCCHN cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process.\n* Patients using only e-cigarettes at the time of initiation of the treatment process.\n* Patients with non-SCCHN cancer in recurrent metastatic stage and not eligible for curative purpose therapy.",{"count":164,"type":21},200,"The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation (\"sustained quitters,\" see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.",[167],"Cancer of Head and Neck",[169,170],"Cancer Head&Neck","Smoker","2025-05-26",{"date":173,"type":58},"2025-05-29",{"date":175,"type":21},"2025-06",{"date":177,"type":21},"2030-05",{"name":64,"class":65},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":189,"studyType":23,"phases":4,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":4},"100591298","ultrasound-and-somatosensory-median-nerve-evaluation-in-crps-i-100591298","NCT06978608","Ultrasound and Somatosensory Median Nerve Evaluation in CRPS I","Ultrasound and Somatosensory Evaluation of the Median Nerve at the Carpal Canal in Patients With CRPS Type I and Clinical Correlation: Definition of Morphologic Patterns","MEDICUS","Inclusion Criteria:\n\n1. patients diagnosed with CRPS assessed at the AOUC's Hand Surgery and Reconstructive Microsurgery SOD\n2. Patients aged 18 years and over\n3. Signature of informed consent for participation in the study and processing of related data\n\nExclusion Criteria:\n\n1. patients suffering from CRPS type II and therefore with known peripheral nerve injury\n2. Patients under 18 years of age",{"count":188,"type":21},50,"1 Month","Complex regional pain syndrome (CRPS) is a disorder falling within the sphere of neuropathic pain, characterised by a plethora of symptoms. Regional pain out of proportion to the triggering event is the main presentation, accompanied by allodynia, dysesthesia, thermal asymmetry, trophic changes, oedema and stiffness. Recently, preliminary observational studies have found that the management of patients with CRPS, refractory to pharmacological treatment, by carpal tunnel release may be resolving; This suggests that an irritative carpal tunnel syndrome may be masked as CRPS due to non-specific symptoms and negative electrodiagnostic studies (electromyography-EMG). Classical carpal tunnel syndrome (CTS) is a well-defined clinical condition that can be ascertained by EMG. In contrast, irritative carpal tunnel syndrome has symptoms attributable to CRPS with negative EMG that arises after trauma that required surgery or immobilisation. It is unclear how to define the presence of irritative carpal tunnel syndrome in patients diagnosed as CRPS, and thus how to make a correct diagnosis. Nor is the management of these patients defined. The aim of the research is to analyse all patients with typical symptoms for CRPS to investigate the morphological appearance of the median nerve at the level of the carpal tunnel by means of dynamic ultrasound in comparison with the healthy limb. In addition, in order to quantify the function of the median nerve, investigators will analyse patients by means of a sensory conduction velocity study (SNVC), as common EMG examinations are negative in these patients, while it is possible that the quantification of the sensory part of the nerve may be impaired. In addition, the autonomic component will be investigated by studying the Skin Sudomotor Response (SSR).The hypothesis is that some patients, after an injury that required surgery or immobilisation, develop fibrous soft tissue scarring that creates a kind of space-occupying lesion that compresses the median nerve at the level of the carpal tunnel and reduces its sliding under the transverse ligament of the carpus, a structure that is not elastic and therefore unable to adapt to the volumetric increases within it. The other hypothesis is that the fibrosis and post-traumatic oedema, which is structured, directly involves the median nerve sheath, resulting in irritation. Classical CTS develops due to mechanical trauma, high pressure and ischaemic damage affecting the median nerve and develops as a clinical condition of pure nerve suffering, with symptoms referable to a sensory and motor deficit. In CRPS, on the other hand, allodynia, hyperalgesia, sudomotor and vasomotor abnormalities and trophic changes are all symptoms that may be related, but are not specific, to nerve suffering.",[192],"CRPS (Complex Regional Pain Syndrome) Type I",[194,195,196,197,198,199],"CRPS","MEDIAN NERVE","CARPAL TUNNEL","SENSORY","ULTRASOUND","SOMATOSENSORY","2025-05-16",{"date":202,"type":58},"2025-05-18",{"date":152,"type":21},{"date":205,"type":21},"2026-02-26",{"name":64,"class":65},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":214,"targetDuration":4,"studyType":78,"phases":216,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":66},"100563774","restoring-hand-function-in-patients-with-tetraplegia-by-intraneural-stimulation-of-peripheral-nerves-100563774","NCT06620536","Restoring Hand Function in Patients with Tetraplegia by Intraneural Stimulation of Peripheral Nerves","REGRASP","Inclusion Criteria:\n\n1. Men or women aged between 18 and 70.\n2. Spinal cord injury at the C5-6 level, with complete motor paralysis (ASIA A or ASIA B).\n3. Chronic injury (\\> 6 months), with stable clinical condition.\n\nExclusion Criteria:\n\n1. Systemic infections.\n2. Central and\u002For peripheral nervous system comorbidity.\n3. Reduced joint flexibility.\n4. Severe spasticity of the upper limb (mAS 3).\n5. Severe denervation of forearm and hand muscles (as demonstrated by electromyography and electroneurography analysis and intraoperative neural stimulation).\n6. Muscles not electrically excitable.\n7. Presence of hyperalgesia or allodynia.\n8. Wearers of life support devices that could be adversely affected by electromagnetic interference, such as pacemakers, implanted cardioverter defibrillators, etc.\n9. Cognitive impairment.\n10. Active or history of psychiatric illnesses including major depression, bipolar disorder and personality disorders (borderline or antisocial personality disorder).\n11. Pregnancy.\n12. History of alcohol or substance abuse.\n13. Acquired brain injury with residual deficits.\n14. Participation in other clinical trials.\n15. Known allergies\u002Fhypersensitivity to TIME-4H electrode materials.\n16. Life expectancy of less than one year.\n17. Contraindications to general anaesthesia (patient refusal, severe aortic stenosis, significant pulmonary disease, etc.).",{"count":215,"type":21},2,[80],"The aim of the clinical investigation is to evaluate the feasibility, in terms of efficacy and safety, of a prosthetic system, the Regrasp 1 system, based on intraneural stimulation via TIME- 4H electrodes, as an aid device for restoring hand function in tetraplegic patients.",[219],"Tetraplegics",[221,222,223,224],"electrodes","intraneural stimulation","hand","tetraplegia","2024-09-27",{"date":227,"type":58},"2024-10-01",{"date":229,"type":21},"2024-10",{"date":231,"type":21},"2026-12",{"name":64,"class":65},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":240,"maxAge":241,"enrollmentInfo":242,"targetDuration":4,"studyType":78,"phases":244,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":4},"100547029","comparison-of-customized-and-standard-facemasks-for-early-treatment-of-class-iii-malocclusion-100547029","NCT06402656","Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion","Comparison of Customized and Standard Facemasks for Early Treatment of Class III Malocclusion: Randomized Crossover Study","Inclusion Criteria:\n\n* Age between 5 and 12 years;\n* Class III malocclusion, for which early orthopedic treatment with rapid maxillary expander and facemask is indicated.\n* signing of informed consent\n\nExclusion Criteria:\n\n* Cleft lip and\u002For palate.\n* Craniofacial syndromes.","5 Years","12 Years",{"count":243,"type":21},24,[80],"The aim of the study is to compare a customized facemask for the treatment of Class III malocclusion in the prepubertal growing patient (patients between the ages of 5 and 12 years) versus a standard commercial facemask. Specifically, preference, pain, difficulty in sleeping, time of use, and possible complications for the two types of facemasks will be analyzed.\n\nThis is a single-center, national, controlled, superiority, randomized, crossover, open-label study.\n\nEach patient will be treated with both the customized facemask and the standard commercial facemask. Each patient will wear one type of facemask for 2 months and the other type of facemask for the next 2 months. After 2 weeks and at the end of therapy with each of the facemask types, the patient, with the possible help of the parents, will have to answer a questionnaire about pain and difficulty sleeping and report any complications. In addition, after completing both phases (fourth month), the patient should indicate a preference for one of the two types of mask with which to complete therapy for an additional 6 months.",[247,248],"Malocclusion, Angle Class III","Extraoral Traction Appliances","2024-07-30",{"date":251,"type":58},"2024-07-31",{"date":253,"type":21},"2024-09-01",{"date":255,"type":21},"2026-01-01",{"name":64,"class":65},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":16,"minAge":264,"maxAge":265,"enrollmentInfo":266,"targetDuration":4,"studyType":78,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":275,"leadSponsor":277,"locationsCount":4},"100556783","comparison-between-cadcam-and-conventional-mandibular-fixed-retainers-100556783","NCT06529601","Comparison Between CAD\u002FCAM and Conventional Mandibular Fixed Retainers.","Comparison Between CAD\u002FCAM and Conventional Mandibular Fixed Retainers: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients who have completed fixed orthodontic therapy between the ages of 13 and 20 years;\n* Patients whose parents will sign the informed consent\n\nExclusion Criteria:\n\n* Presence of dental anomalies in number (excess or deficiency) in the lower anterior teeth\n* Patients with metal allergies.","13 Years","20 Years",{"count":267,"type":21},54,[80],"The devices compared in this study are 'retainers', i.e. fixed orthodontic retainers applied to the lingual surface of the central and lateral incisors and lower canines bilaterally. Their function is to maintain dental alignment once fixed orthodontic therapy has ended. In particular, the CAD\u002FCAM device Keeppy patented by the company Leone SpA (Via Ponte a Quaracchi 50, Sesto Fiorentino, Florence) will be compared with the standard retainer made from a steel braided wire (Ortho FlexTech, Reliance Orthodontic Products Inc., 1540 West Thorndale Ave, Itasca, Illinois, USA).\n\nThis is a single-center, national, controlled, superiority, randomized, crossover, open-label study.\n\nThe aim of this study is to evaluate whether the CAD\u002FCAM retainer results in fewer failures (fractures or detachments) over a period of 6 months and 2 years compared to the standard retainer. In addition, the aim of the study is to evaluate whether the Keeppy device results in the maintenance of better periodontal health as judged by the use of plaque and bleeding indices on the surfaces of the lower six anterior teeth compared to the standard retainer. Other objectives consist of the patient's assessment of pain, difficulty in speaking and esthetic satisfaction and the stability of the lower anterior tooth sector.",[271],"Orthodontic Retainers","2024-07-29",{"date":251,"type":58},{"date":253,"type":21},{"date":276,"type":21},"2027-09-01",{"name":64,"class":65},{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":288,"studyType":23,"phases":4,"briefSummary":289,"conditions":290,"keywords":293,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":66},"100555017","hcapped-i-hcap-pcr-in-emergency-department-100555017","NCT06506617","HCAPPED I: HCAP-Pcr in Emergency Department","HCAPPED I: HCAP - Pcr in Emergency Department. Early Multiplex PCR on Respiratory Samples From Patients With Pneumonia. A No-profit Observation Prospective Study","HCAPPED-I","Inclusion Criteria:\n\nAll patients over the age of 18 who undergo bronchoalveolar lavage (BAL) in the Emergency Department (DEA), with a Rankin score of less than 5, and who are admitted to the Emergency Department with a diagnosis of healthcare-associated pneumonia (HCAP) of bacterial, viral, or fungal origin. The diagnosis must be confirmed by clinical and radiological criteria according to the IDSA guidelines, which include: New pulmonary infiltrate on chest X-ray, Evidence that the infiltrate is of infectious origin, At least two of the following three clinical signs: Fever higher than 38 °C, Leukocytosis or leukopenia, Purulent secretions.\n\nAdditionally, patients must meet at least one of the following criteria:\n\n* Need for high-flow oxygen therapy (VM35 or FiO2 \\>35%, Reservoir, HFNC, NIV, CPAP)\n* Intubation (IOT)\n* SOFA score ≥2 or PSI score \\>85 (age 75 + IR)\n* Horowitz index (PaO2\u002FFiO2) \\< 200\n\nExclusion Criteria:\n\n* Lack of consent\n* Age under 18 or over 90\n* Pregnancy\n* Life expectancy less than 3 months\n* Hospital admission \\>48 hours (hospital-acquired pneumonia - HAP)\n* Rankin score ≥ 5\n* Community-acquired pneumonia (CAP)",{"count":287,"type":21},93,"90 Days","Prospective Observational Study (on Diagnostic Procedure) - Single-Center, Non-Profit.\n\nA pilot study will be conducted on a prospective cohort of patients with HCAP (Healthcare-Associated Pneumonia). This study will be conducted on a single arm of patients. No control group or randomization is planned.\n\nThe use of syndromic molecular panels in pneumonias with risk factors for MDR (multidrug-resistant) pathogens, such as in patients with HCAP, has become common practice. However, the use of this tool is reserved for patients with severe forms of HCAP (PIRO\\>2, at least moderate ARDS, and respiratory failure requiring high-flow oxygen during sepsis) (30), and it is not yet standardized by international guidelines. The decision to use this tool or not is currently at the clinician\\'s discretion and is usually reserved for the severe forms mentioned above. The study aims to determine if the early use of this tool has a real benefit on the management of antibiotic therapy for these patients in terms of therapeutic changes compared to corporate and international guidelines.\n\nDuration of patient enrollment: 1 year. Duration of the study: 1.5 years.",[26,47,291,292],"Antimicrobial Treatment","Sputum",[294,295,296,297,298,299,300,301,302,303,304],"Bronchoalveolar lavage","Endotracheal Aspirate","Antimicrobial treatment","pneumonia","hcap","pcr multiplex","moleculas syndromic panel","bal","bas","eta","sputum","2024-07-16",{"date":307,"type":58},"2024-07-17",{"date":309,"type":58},"2024-06-07",{"date":311,"type":21},"2026-01-07",{"name":64,"class":65},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":66},"100555399","fbs-asap-fibrobronchoscopy-in-aspiration-pneumonia-in-the-emergency-department-100555399","NCT06511583","FBS-ASaP: Fibrobronchoscopy in ASpiration Pneumonia in the Emergency Department","FBS-ASaP","Inclusion Criteria:\n\nAll adult patients who access the Emergency Department with a diagnosis of aspiration pneumonia and for whom the referring physician determines the need for aspiration of secretions or ingesta. Patients must have at least one of the following criteria\n\n* Radiological evidence of pneumonia (Chest X-ray\u002FCT scan\u002FChest ultrasound)\n* Clinical diagnosis of aspiration pneumonia\n* Presence of secretions in the upper airways\n* Respiratory distress in a dysphagic patient\n* Need for oxygen therapy or need to increase FiO2 in patients already on home oxygen therapy\n\nExclusion Criteria:\n\n* Lack of consent\n* Age \\< 18 years\n* Pregnancy\n* Hemorrhagic diathesis\n* Malignant cardiac arrhythmias (VT, AV block excluding first-degree AV block)\n* Severe airway obstruction",{"count":321,"type":21},100,"Non-Profit Prospective Observational Pilot Study\n\nThe study will have an overall duration of 3 years, with patient enrollment starting after ethical committee approval.\n\nIn this study, all patients with a diagnosis of aspiration pneumonia who require aspiration of secretions or ingesta in the Emergency Department will be considered. A registry will be created with the patients\\' data, noting the type of procedure performed: laryngotracheal aspiration with a probe or with fibrobronchoscopy.\n\nThis observational registry pilot study aims to evaluate the utility and adverse events related to the use of aspiration via videobronchoscopy performed in the Emergency Department and to compare the clinical outcomes of patients undergoing bronchoscopy with those treated only with blind laryngotracheal aspiration using a probe.",[324,325],"Aspiration Pneumonia","Bronchoscopy",[327,325,328,329,330,297,331],"Aspiration pneumonia","toilette","interventional pulmunology","respiratory failure","bacterial pneumonia","2024-07-15",{"date":334,"type":58},"2024-07-22",{"date":336,"type":58},"2024-02-05",{"date":338,"type":21},"2027-03-05",{"name":64,"class":65},{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":344,"acronym":4,"eligibilityCriteria":345,"healthyVolunteers":11,"sex":16,"minAge":346,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":66},"100553838","modelling-of-correlation-between-emergency-department-admissions-and-location-specific-air-quality-and-weather-in-the-florence-urban-area-100553838","NCT06491290","Modelling of Correlation Between Emergency Department Admissions and Location-specific Air Quality and Weather in the Florence Urban Area","Inclusion Criteria:\n\n* Consecutive emergency department visits within the study period\n\nExclusion Criteria:\n\n* Patients resident outside the metropolitan area investigated\n* Patients admitted to the emergency department for traumatic injuries","14 Years",{"count":348,"type":21},480000,"The goal of this observational study is to evaluate the impact of primary air pollutants and weather parameters on emergency department (ED) visits in the metropolitan area of Florence.",[351,352,353],"Emergency Service, Hospital","Air Pollution","Weather","2024-07-08",{"date":356,"type":58},"2024-07-09",{"date":358,"type":58},"2024-01-01",{"date":360,"type":21},"2027-12-31",{"name":64,"class":65},{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":78,"phases":371,"briefSummary":372,"conditions":373,"keywords":375,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":66},"100497731","sarcoma-preoperative-radiation-with-simultaneous-integrated-boost-sprint-100497731","NCT05761054","Sarcoma Preoperative Radiation With Simultaneous INTegrated Boost (SPRINT)","SPRINT","Inclusion Criteria:\n\n* Patients aged ≥ 18 years\n* Confirmed histological diagnosis of soft tissue sarcoma\n* Candidate for conservative surgery\n* Performance status ≤ 1 according to WHO (or ≥ 70 according to KPS) before starting the treatment in the office.\n\nExclusion Criteria:\n\n* Previous radiotherapy at the same site\n* Candidate for Surgical Amputation\n* Patients with comorbidities for collagen diseases\n* Psychiatric disorders that may preclude obtaining the informed consent",{"count":370,"type":21},33,[80],"Intervention prospective monocentric one arm study on the use of neoadjuvant radiotherapy with simultaneous integrated boost (Simultaneous Integrated Boost, SIB) in patients with STS with indication for preoperative radiotherapy. The treatment will be administered in 25 daily fractions (Monday-Friday) at the disease site to include the region of suspected micrometastatic spread (Clinical Target Volume 1, CTV1) at a dose of 50 Gy (2Gy\n\n\u002F fraction) with SIB intensification on volume reduced corresponding to the interface sites between the tumor and the vascular \u002F nerve axes (Clinical Target Volume 2, CTV2) at a dose of 60 Gy (2.4 Gy \u002F fraction). The association with neoadjuvant chemotherapy based on anthracyclines is allowed.",[374],"Soft Tissue Sarcoma",[376,377,378,379,380],"soft tissue sarcoma (STS)","Intensity Modulated Radiotherapy (IMRT)","boost","radiotherapy","locally advanced soft tissue sarcoma","2023-02-27",{"date":383,"type":58},"2023-03-09",{"date":385,"type":58},"2022-07-19",{"date":387,"type":21},"2027-07-01",{"name":64,"class":65},{"id":390,"slug":391,"hasResults":11,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":418},"100467200","international-registry-of-conservative-or-radical-treatment-of-localized-kidney-tumors-100467200","NCT05363657","International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors","International REgistry of COnservative or Radical Treatment of Localized Kidney Tumors (i-RECORd)","i-RECORd","Inclusion Criteria:\n\n* Radiological diagnosis of renal tumor susceptible to active treatment or AS\u002FWW.\n* Age ≥18 years\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patient refuse to participate in clinical research.\n* Urothelial renal carcinoma.",{"count":398,"type":21},10000,"Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (\\\u003C7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors.\n\nIn the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics.\n\nTo meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project.\n\nThe expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years).",[401],"Kidney Cancer",[403,404,405,406,407,408,409],"Kidney cancer","Partial Nephrectomy","Radical Nephrectomy","Ablation Techniques","Active Surveillance","Recurrence Free Survival","Watchful Waiting","2022-05-02",{"date":412,"type":58},"2022-05-06",{"date":414,"type":58},"2022-01-10",{"date":416,"type":21},"2028-12-31",{"name":64,"class":65},37,{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":427,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":430,"conditions":431,"keywords":436,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":66},"100441022","psma-guided-approach-for-biochemical-relapse-after-prostatectomy-psiche-100441022","NCT05022914","PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE","Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE","PSICHE","Inclusion Criteria:\n\n* Signed informed consent\n* Age \\>18\n* Patient suitable for 68Ga-PSMA PET\u002FCT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +\u002F- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA \\> 0.2 and \\\u003C1\n\nExclusion Criteria:\n\n* ADT administration within 6 months from study enrollment\n* Persistent elevation of PSA after RP measured within 16 weeks from surgery (\\> 0.1 ng\u002Fml)","MALE",{"count":429,"type":21},180,"This observational study was designed to evaluate progression free survival after PSMA-PET\u002FCT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.",[432,433,434,435],"Prostate Cancer","Biochemical Relapse Fo Malignant Neoplasm of Prostate","Prostate Adenocarcinoma","Prostate Cancer Recurrent",[437,438,439,440,441,442,443],"PSMA","68Ga-PSMA PET\u002FCT","PET\u002FCT","Biochemical Relapse","micro-RNA","SBRT","Radiotherapy","2021-08-24",{"date":446,"type":58},"2021-08-26",{"date":448,"type":58},"2021-01-19",{"date":450,"type":21},"2027-01-19",{"name":64,"class":65},""]