[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ultrasound-elastography\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ultrasound-elastography":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100492429","phase-1-coffee-and-metabolites-modulating-the-gut-microbiome-in-colorectal-cancer-100492429",false,"NCT05692024","COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER","Inclusion Criteria:\n\nParticipants must meet the following criteria on screening examination to be eligible to participate in the study:\n\n* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.\n* Age 18 years or older.\n* This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.\n* The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Subjects must be able and willing to follow study procedures and instructions.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nParticipants who exhibit any of the following conditions at screening will not be eligible for admission into the study.\n\n* Participants who are receiving any other investigational agents.\n* Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.\n* Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.\n* Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).\n* History of diagnosed conditions that may be worsen by coffee, including arrhythmias, insomnia, tremors, tics, generalized anxiety disorder, bipolar disease, panic attacks, Tourette's, epilepsy or overactive bladder.\n* History of adverse reactions to coffee or intolerance of coffee consumption.\n* Inability or unwillingness to swallow capsules.\n* History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.\n* Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.\n* Pregnant or breastfeeding. The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nShould a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with coffee. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.\n\n* Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.\n* Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.",[28,29,30,31,32,33,34],"Colorectal Cancer","Coffee","Gastrointestinal Microbiome","Stenosis","Fibrosis, Liver","Ultrasound Elastography","Proton Magnetic Resonance Spectroscopy",[36,37,38,29,39],"Liver fat","Gut microbiome","Colorectal cancer","Tumor biopsy","RECRUITING","2026-04-29",{"date":43,"type":44},"2026-05-05","ACTUAL",{"date":46,"type":44},"2024-03-21",{"date":48,"type":21},"2028-08-31",{"name":50,"class":51},"Massachusetts General Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":52},"100630837","multiparametric-ultrasound-for-the-noninvasive-diagnosis-of-porto-sinusoidal-vascular-liver-disorder-100630837","NCT07492862","Multiparametric Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder","Explorative Study for the Application of Dynamic Contrast-enhanced Ultrasound for the Noninvasive Diagnosis of Porto-sinusoidal Vascular Liver Disorder","CEUS-PSVD","Inclusion criteria - PSVD group\n\n* Histologically confirmed diagnosis of porto-sinusoidal vascular disease (PSVD);\n* Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);\n* Age ≥ 18 years;\n* Ability to understand the study information and provide written informed consent;\n\nInclusion criteria - Cirrhosis group\n\n* Diagnosis of liver cirrhosis confirmed by liver histology or, alternatively, by compatible findings on imaging, laboratory tests, and physical examination together with a positive history for at least one known cause of chronic liver disease;\n* Presence of clinically significant portal hypertension, evidenced by at least one specific sign of portal hypertension (e.g., imaging evidence of collateral circulation or porto-systemic shunts, endoscopic evidence of esophageal or gastric varices, or history of gastrointestinal variceal bleeding);\n* Age ≥ 18 years;\n* Ability to understand the study information and provide written informed consent.\n\nExclusion criteria - PSVD group (cases)\n\n* Presence of other causes of portal hypertension, including but not limited to: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, or chronic cholestatic liver diseases;\n* Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;\n* Prior hepatic or splenic surgery;\n* Presence of primary or secondary malignant liver tumors;\n* Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device;\n* Congenital anomalies of the liver or biliary tract;\n* History of heart failure;\n* Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome;\n* Inadequate sonographic visualization of the right hepatic lobe;\n* Pregnancy.\n\nExclusion criteria - Cirrhosis group\n\n* Decompensated cirrhosis or Child-Pugh class C;\n* Cryptogenic cirrhosis;\n* Presence of other causes of portal hypertension (same list as for PSVD exclusions: history of bone marrow transplantation, Budd-Chiari syndrome or hepatic venous outflow obstruction, hepatic schistosomiasis, Abernethy malformation, hereditary hemorrhagic telangiectasia, sarcoidosis, congenital hepatic fibrosis, chronic cholestatic diseases);\n* Presence of portal, spleno-mesenteric, or hepatic vein thrombosis;\n* Prior hepatic or splenic surgery;\n* Presence of primary or secondary malignant liver tumors;\n* Presence of a transjugular intrahepatic portosystemic shunt (TIPS) device;\n* Congenital anomalies of the liver or biliary tract;\n* History of heart failure;\n* Contraindications to administration of SonoVue (sulfur hexafluoride microbubbles), including: prior allergic reaction to the active substance or any excipients, known right-to-left shunts, severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg), uncontrolled systemic hypertension, or adult respiratory distress syndrome;\n* Inadequate sonographic visualization of the right hepatic lobe;\n* Pregnancy.",{"count":62,"type":21},100,[64],"NA","Porto-sinusoidal vascular disease (PSVD) is a rare clinical entity characterized by significant portal hypertension in the absence of cirrhosis on liver histology, which may or may not show specific alterations of the portal vein, sinusoids, or hepatic lobular architecture. Currently, diagnosis of this condition necessarily requires a liver biopsy and, despite some differences detected on imaging studies-and particularly on liver and spleen elastography-PSVD remains indistinguishable from cirrhosis using non-invasive tests.\n\nContrast-enhanced ultrasound (CEUS) is an easy-to-perform, repeatable, and cost-effective examination that enables real-time assessment of parenchymal or focal liver lesion perfusion. Moreover, the application of dynamic contrast-enhanced ultrasound (DCE-US-i.e., contrast-enhanced ultrasound followed by quantitative perfusion analysis using dedicated software, such as the VueBox Software that will be used in this study) allows integration of CEUS qualitative assessment with quantitative evaluation of tissue perfusion through analysis of time-intensity curves generated during contrast transit. From this analysis, several perfusion-related parameters can be derived (for example, peak enhancement, time to peak, or area under the curve), which have already proven useful in improving differential diagnosis of focal liver lesions and in predicting treatment response and systemic therapy outcomes.\n\nTo date, the use of DCE-US for the diagnosis of PSVD has not yet been described; however, based on the underlying histological alterations associated with this disease, it is reasonable to hypothesize that parameters obtained with this technique in the liver parenchyma of patients with PSVD may differ from those measured in patients with liver cirrhosis. The aim of the present project is to apply DCE-US in patients with PSVD and in patients with cirrhosis to evaluate potential significant differences in perfusion parameters, and to assess the feasibility of a non-invasive differential diagnosis between the two conditions using this technique in combination with elastography and bidimensional ultrasound data to develop a multiparametric diagnostic score.",[67,68,69,70,33,71],"Porto-sinusoidal Vascular Liver Disorder","Liver Cirrhosis","Portal Hypertension, Noncirrhotic","Portal Hypertension Related to Cirrhosis","Contrast-enhanced Ultrasound",[73,74,75,76,77,78],"porto-sinusoidal vascular liver disorder","liver cirrhosis","liver ultrasound","ultrasound elastography","dynamic contrast-enhanced ultrasound","chronic liver disease","NOT_YET_RECRUITING","2026-03-20",{"date":82,"type":44},"2026-03-25",{"date":84,"type":21},"2026-03",{"date":86,"type":21},"2028-12",{"name":88,"class":51},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]