[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Icahn School of Medicine at Mount Sinai\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":658},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,171,0,25,[9,51,74,97,121,143,169,199,221,248,272,300,328,356,376,399,423,444,465,483,508,531,562,588,605],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100650503","increasing-breast-and-colorectal-cancer-screening-in-the-community-100650503",false,"NCT07748377","Increasing Breast and Colorectal Cancer Screening in the Community","A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening","Inclusion Criteria:\n\n* Age 45-75 years old\n* Self-identify as Chinese and born outside of the U.S.\n* Speaks Mandarin, Cantonese, or English\n* Not up to date on BC screening (i.e., have not had a mammogram within the past two years)\n* Not up to date on CRC screening (i.e., have not had any of the following tests)\n\n  * Colonoscopy within the past 10 years\n  * Fecal immunochemical tests\u002Ffecal occult blood tests within the past year or multi-target stool DNA test within the past three years\n  * Flexible sigmoidoscopy within the past 5 years\n  * CT colonography within the past 5 years\n\nExclusion Criteria:\n\n* Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended\n* Personal history of BC or CRC\n* Prior history of a total colectomy or mastectomy\n* Lacks capacity to provide informed consent",true,"FEMALE","45 Years","75 Years",{"count":22,"type":23},80,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.",[29,30],"Colorectal Neoplasms","Breast Neoplasms",[32,33,34,35,36,37],"Community Engaged Research","Early Detection of Cancer","Colorectal Cancer Screening","Breast Cancer Screening","Patient Navigation","Community Health Workers","NOT_YET_RECRUITING","2026-08-12",{"date":41,"type":42},"2026-08-14","ACTUAL",{"date":44,"type":23},"2026-09",{"date":46,"type":23},"2029-03",{"name":48,"class":49},"Icahn School of Medicine at Mount Sinai","OTHER",7,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":24,"phases":62,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":73},"100644022","tract-closure-in-pcnl-100644022","NCT07668817","Tract Closure in PCNL","Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques","Inclusion criteria:\n\n* At least one stone ≥ 1.2cm\n* Scheduled to undergo planned PCNL\n* Age ≥ 18 years\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Pre-existing nephrostomy tube\n* Multi access cases\n* Stone in calyceal diverticulum\u002Fhydrocalyx\n* Preoperatively planned overnight admission for any reason\n* Infundibular stenosis\n* Coagulation disorders\n* Other significant anatomic abnormalities","ALL","18 Years",{"count":61,"type":23},92,[26],"This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.",[65],"Nephrolithiasis","RECRUITING",{"date":41,"type":42},{"date":69,"type":23},"2026-08",{"date":71,"type":23},"2028-06",{"name":48,"class":49},1,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":73},"100610298","phase-4-caox-stone-prevention-100610298","NCT07225764","CaOx Stone Prevention","Empiric vs Selective Medical Therapy for Calcium Oxalate Stone Prevention: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adult age of 18 years\n* Diagnosed with kidney stones and scheduled for PCNL.\n* Calcium Oxalate Stone Former\n* Pre-operative CT-scan within 90 days of surgery and stone density with \\> 1000 Hounsfield units\n* Non-pregnant or breastfeeding\n* Able and willing to provide informed consent.\n* Pre-operative eGFR greater than 70 mL\u002Fmin\u002F1.73 m² -Negative pre-operative urine culture\n\nExclusion Criteria:\n\n* Documented history of gastric or intestinal bypass, liver disease, history of gastrointestinal malabsorptive disease (Crohn's disease, ulcerative colitis, and short-gut syndrome)\n* Hyperparathyroidism -Renal tubular acidosis\n* Active kidney stone prevention treatment (use of thiazides, alkaline therapy, or low oxalate diet) at the time of surgery\n* History of hypokalemia or baseline hypotension\n* Allergy to medications used in trial or sulfa-containing medications\n* Patient prescribed thiazide, loop diuretics, carbonic anhydrase inhibitors, xanthine oxidase inhibitors, active Vitamin D, bisphosphonates, denosumab, glucocorticoids, or potassium supplementation",{"count":22,"type":23},[83],"PHASE4","This single-center randomized controlled trial at Mount Sinai West will enroll 80 patients undergoing percutaneous nephrolithotomy for calcium oxalate stones. Participants will be randomized to receive either empiric therapy or selective therapy guided by 24-hour urine evaluation. The primary outcome is change in calcium oxalate supersaturation at 4 weeks, aiming to determine whether empiric therapy can provide outcomes comparable to selective therapy while simplifying access to prevention.",[86],"Kidney Stones",[88,89,90],"kidney stones","calcium oxalate","nephrolithiasis",{"date":41,"type":42},{"date":93,"type":42},"2025-10-23",{"date":95,"type":23},"2027-12-31",{"name":48,"class":49},{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":17,"sex":18,"minAge":59,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":24,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100582090","validating-cgm-for-gdm-100582090","NCT06858787","Validating CGM for GDM","The Validity of a Continuous Glucose Monitor in Diagnosing Gestational Diabetes: A Pilot Study","VALID","Inclusion Criteria:\n\n* Ages 18-50\n* Singleton pregnancy between 24-32 weeks gestational age\n* Prenatal care and delivery at Mount Sinai Hospital\n\nExclusion Criteria:\n\n* Multiple fetal gestation\n* Preexisting diabetes\n* Concurrent use of steroids\n* Anomalous fetus\n* Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)\n* Unable to tolerate oral glucose test","50 Years",{"count":107,"type":23},150,[26],"This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.",[111],"Gestational Diabetes Mellitus (GDM)","2026-08-11",{"date":114,"type":42},"2026-08-13",{"date":116,"type":42},"2025-10-02",{"date":118,"type":23},"2028-04",{"name":48,"class":49},3,{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":24,"phases":130,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":73},"100519240","phase-1-sacituzumab-govitecan-in-combination-with-cisplatin-in-platinum-sensitive-recurrent-ovarian-and-endometrial-cancer-100519240","NCT06040970","Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer","A Single-Center, Open-Label, Single-Arm, Phase I Study With Dose Expansion Cohort of Sacituzumab Govitecan in Combination With Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer","Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria to be registered to the study. Study treatment may not begin until a subject is registered.\n\nInclusion Criteria:\n\n* Pathologic (histology or cytology) confirmed diagnosis of epithelial ovarian cancer or endometrial cancer\n* Radiographic evidence of recurrent epithelial ovarian cancer (ovarian, fallopian tube, or primary peritoneal cancer) or endometrial cancer that is \"platinum-sensitive,\" defined as progression of disease beyond 6 months from the last dose of platinum-based chemotherapy\n* Female, age ≥ 18 years\n* World Health Organization (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks\n* Patient has measurable disease (at least one lesion that can be accurately assessed repeatedly by CT) as evidenced on pre-treatment baseline CT of Chest\u002FAbdomen\u002FPelvis or PET\u002FCT, or evaluable disease\n* Adequate hematologic counts, as defined below, without transfusion or growth factor support within 2 weeks of study drug initiation:\n\n  * Hemoglobin ≥ 8.5 g\u002FdL\n  * Absolute neutrophil count ≥ 1500\u002Fmm3\n  * Platelets ≥ 100,000\u002FμL\n* Adequate organ function as defined below:\n\n  * Total bilirubin ≤ 1.5 ULN\n  * AST(SGOT)\u002FALT(SPGT) ≤ 2.5x ULN or ≤ 5 x ULN if known liver metastases\n  * Serum albumin \\> 3 g\u002FdL\n  * Creatinine clearance ≥ 50 mL\u002Fmin per the Cockcroft-Gault equation\n* Women of childbearing potential must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\n  o A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nTreatment with any of the following:\n\n* Any investigational agents or study drugs from a previous clinical study within 28 days or 5 half-lives (whichever is longer) of the first dose of study treatment\n* Any other chemotherapy, immunotherapy or anticancer agents within 14 days of the first dose of study treatment\n* Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment\n* Radiotherapy with a wide field of radiation within 4 weeks or radiotherapy with a limited field of radiation for palliation within 2 weeks of the first dose of study treatment\n* With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment\n* As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or uncontrolled infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n* Known or severe (Grade 3 or higher) hypersensitivity to SG and\u002For cisplatin, their metabolites, or formulation excipients\n* Peripheral neuropathy grade 2 or greater\n* Refractory nausea and vomiting, chronic gastrointestinal diseases\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Women of childbearing potential unwilling to use effective contraception during study until conclusion of 6-month post-treatment evaluation period\n* Known history of unstable angina, MI, or CHF present within 6 months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy\n* Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months of enrollment.\n* Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.\n* Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n* Prior therapy with sacituzumab govitecan, irinotecan, Trop-2-directed antibody drug conjugate, or any topoisomerase I-containing antibody-drug conjugates at any time for early stage disease\n* Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n* Requirement for ongoing therapy with any prohibited medications\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease for ≥ 4 weeks prior to randomization and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking 10 mg\u002Fday or less of prednisone or its equivalent. All participants with carcinomatous meningitis are excluded regardless of clinical stability.\n* Have an active second malignancy. Participants with a history of malignancy that have been completely treated, with no evidence of active cancer for 3 years prior to randomization, or participants with surgically cured tumors with low risk of recurrence (e.g., nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n* Use of any live vaccine against infectious diseases within 30 days of the first dose of study drugs.\n* Have an active serious infection requiring systemic antimicrobial therapy",{"count":129,"type":23},54,[131,132],"PHASE1","PHASE2","This is an open-label, Phase 1 study with a dose expansion cohort of Sacituzumab Govitecan in Combination with Cisplatin in Platinum Sensitive Recurrent Ovarian and Endometrial Cancer. The goal of the study is to determine the optimal dose of sacituzumab govitecan for use in combination with cisplatin for treatment of epithelial ovarian and endometrial cancers.",[135,136],"Ovarian Cancer","Malignant Neoplasm of Uterus",{"date":114,"type":42},{"date":139,"type":42},"2024-10-28",{"date":141,"type":23},"2032-07-01",{"name":48,"class":49},{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":58,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":4,"studyType":24,"phases":153,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":73},"100456407","the-effects-of-entrainment-on-respiratory-stability-and-cerebral-oxygenation-in-preterm-infants-100456407","NCT05223192","The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants","Inclusion Criteria:\n\n* Newborns born at 24-37 weeks' gestation at Mount Sinai hospital\n* Newborn is considered appropriate for clinically indicated music therapy\n\nExclusion Criteria:\n\n* Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)\n* Infant of uncertain viability (gestation \\\u003C23 weeks, birth weight \\\u003C500 grams)\n* Known or suspected genetic disorder (e.g., Trisomy 21)\n* Identified hearing disorder","24 Weeks","37 Weeks",{"count":152,"type":23},120,[26],"Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention\u002Fsilence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.",[156],"Prematurity",[158,159,160,161,162],"music therapy","ocean disc","prematurity","vital signs","cerebral oxygenation",{"date":114,"type":42},{"date":165,"type":42},"2022-04-01",{"date":167,"type":23},"2026-12-31",{"name":48,"class":49},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":73},"100649188","isocaloric-navy-bean-substitution-in-adults-with-masld-100649188","NCT07730853","Isocaloric Navy-Bean Substitution in Adults With MASLD","Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)","BEAN-MASLD","Inclusion Criteria:\n\n* Adults 18-75 years of age with capacity to provide informed consent\n* Clinical diagnosis of MASLD, confirmed by imaging (MRI-PDFF or VCTE) or prior liver biopsy.\n* Intermediate-stage fibrosis (F2-F3) confirmed by one of the following (most recent qualifying result): VCTE (FibroScan) 8.0-14 kPa, MRE 3.0-4.6 kPa (2D EPI @ 60 Hz), or liver biopsy read as F2-F3\n* Body mass index 25-45 kg\u002Fm²\n* Stable medications for ≥12 weeks for diabetes, hypertension, dyslipidemia, or weight management\n* Alcohol intake below MASLD thresholds (≤15 drinks\u002Fweek for men, ≤10 drinks\u002Fweek for women)\n* Willing and able to consume study navy beans and complete dietary recalls (ASA-24\u002FDSQ)\n* Able to undergo MRI and MRE (no contraindications) and attend study visits\n* Agrees to biospecimen collection (blood, stool, saliva) and patient-reported outcomes\n\nExclusion Criteria:\n\n* Other chronic liver disease (hepatitis B, hepatitis C, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis)\n* Decompensated liver disease (ascites, variceal bleeding, encephalopathy) or Child-Pugh B\u002FC cirrhosis, or clinical portal hypertension\u002Fdecompensation\n* Heavy alcohol use above MASLD thresholds, or alcohol use disorder within 12 months\n* Legume\u002Fbean allergy or intolerance\n* Initiation or dose change of antidiabetic, lipid-lowering, antihypertensive, or weight-loss medications within the past 12 weeks, or anticipated changes during the trial\n* Recent initiation of agents known to affect hepatic fat or fibrosis (e.g., GLP-1 receptor agonist, SGLT2 inhibitor, pioglitazone, resmetirom) within 12 weeks\n* Use of hepatotoxic drugs likely to confound liver enzymes in the prior 12 weeks (per investigator judgment)\n* New supplements targeting weight loss, liver health, or the microbiome within 8-12 weeks (e.g., berberine, high-dose omega-3, pre\u002Fprobiotics)\n* Antibiotics, probiotics, or colonoscopy preparation within 8 weeks\n* Planned bariatric surgery or other major weight-loss intervention during the study\n* Recent weight change \\>5% within 8-12 weeks prior to baseline\n* Severe gastrointestinal disease (inflammatory bowel disease, celiac disease, short bowel syndrome) that may impair tolerance\n* Uncontrolled diabetes (HbA1c \\>10%), severe renal dysfunction (eGFR \\\u003C45), or unstable cardiovascular, thyroid, or psychiatric illness\n* Pregnant or breastfeeding\n* Contraindications to MRI (e.g., non-compatible implants, severe claustrophobia)\n* Participation in another interventional study within the last 30 days",{"count":178,"type":23},40,[26],"This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.",[182,183,184],"Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Liver Fibrosis","Metabolic Dysfunction-Associated Steatohepatitis (MASH)",[186,187,188,189,190,191],"Navy beans","Dietary intervention","Isocaloric substitution","Gut microbiome","Gut-liver axis","Liver stiffness","2026-08-10",{"date":39,"type":42},{"date":195,"type":23},"2026-09-01",{"date":197,"type":23},"2029-08-31",{"name":48,"class":49},{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":24,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100555477","behavioral-therapy-for-crohns-disease-100555477","NCT06512597","Behavioral Therapy for Crohn's Disease","Combination Therapy of Resilience Intervention With Biologics in Crohn's Disease (CATHARSIS Trial)","Inclusion Criteria:\n\n* Adults (18-65 years old) of any sex, gender, and racial\u002Fethnic background with an endoscopically and histologically confirmed CD diagnosis will be eligible.\n* Participants must have active CD symptoms as defined by a Crohn's Disease Activity Index (CDAI) of at least 220 and\n* Active endoscopic inflammation defined as a Simple Endoscopic Score for CD (SES-CD) \\> 6 (or ≥4 for isolated ileal disease) on most recent colonoscopy OR active disease on imaging study OR elevated calprotectin\u002FCRP levels\n* Must be planning to start an anti-TNF (adalimumab, certolizumab, or infliximab) or anti-IL-23 (risankizumab, guselkumab, mirikizumab) within the prior 2 weeks or in the next 6 weeks.\n* Participants will need to live in one of Dr Keefer's 30+ PSYPACT licensed states.\n\nExclusion Criteria:\n\n* Endoscopically inactive Crohn's disease at baseline.\n* Unable to consent to participation.\n* Pregnant or planning to become pregnant in next 12 months.\n* Severe psychiatric symptoms.\n* Surgical history for CD.","65 Years",{"count":208,"type":23},170,[26],"People living with Crohn's disease (CD) experience psychological and emotional symptoms, in addition to known chronic and disabling physical symptoms, which prevent them from living their life to the fullest (flourishing). Depression and anxiety are experienced by 30% of people living with CD and 60% of inflammatory bowel disease (IBD) patients continue to report chronic pain, stress, sleeplessness, and fatigue, even when they are \"objectively\" in remission. Psychological stress has been endorsed by 70% of patients with IBD as a key trigger for disease activity which is not surprising given the significance of the gut-brain-microbiome axis, the close communication between the enteric and autonomic nervous systems, and the role of the hypothalamic-pituitary axis and its neuroendocrine and immune functions in the expression of GI symptoms. Interestingly, up to 85% of patients with CD also endorse the positive impact of effective coping skills on disease course. The PI's prior work has suggested that early provision of effective coping strategies, offered at the time of diagnosis or more precisely, immediately prior to biologic medication initiation, could potentially result in faster healing and improved well-being, likely through the combination of 1) physiological mitigation of the stress response and optimization of the gut-brain-microbiome axis; and 2) promotion of effective coping and disease self-management behaviors that promote psychological flourishing despite disease. Unfortunately, to date, early effective psychosocial care has been limited by concerns over reimbursement for psychological services, access to qualified IBD mental health professionals, and the lack of a standardized methodology focused on the brain-gut stress response and how to assess, monitor, communicate and maintain tight control over both physical and emotional well-being. CATHARSIS is a rigorous, placebo-controlled, randomized controlled trial of coping strategies plus medication for 170 people living with Crohn's for less than 5 years who are about to start a new biologic medication due to active disease. Outcomes include improvements in emotional well-being as well as clinical and endoscopic remission over a 12-month period. The overall goal of the study is to demonstrate that it is essential to combine biologic therapy and psychosocial care to ensure optimal and long-term positive outcomes in CD.",[212],"Crohn's Disease","2026-08-09",{"date":39,"type":42},{"date":216,"type":42},"2024-11-01",{"date":218,"type":23},"2028-07-30",{"name":48,"class":49},2,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":231,"conditions":232,"keywords":234,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":120},"100644138","delayed-toxicities-post-car-t-100644138","NCT07665307","Delayed Toxicities Post-CAR-T","An Umbrella Observational Study to Determine Novel Actionable Biomarkers, Mechanisms, and Mitigation of Rare Chimeric Antigen Receptor T Cell (CAR-T) Toxicities in Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Inclusion Criteria:\n\n* Subject is ≥18 years of age at the time of signing the informed consent form (ICF).\n* Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n* Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n* All subjects must have documented diagnosis of MM and be eligible for commercial CAR-T therapy with cilta-cel. Patients planned for standard of care cilta-cel whose cell product is considered out of specification after manufacture will still be eligible to proceed with the current study protocol if proceeding with cilta-cel infusion\n* All patients must have ECOG Performance Status ≤ 2.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis (no active multiple myeloma), Waldenström's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n* Subjects with active plasma cell leukemia (defined as either 5% of peripheral blood white blood cell count comprised of plasma\u002FCD138+ cells or an absolute plasma cell count of 2 x 109\u002FL)\n* Subjects with active Central Nervous System (CNS) involvement with multiple myeloma\n* Cardiac conditions including:\n\n  * New York Heart Associated class 3 or 4 congestive heart failure\n  * Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia\n  * History of severe non-ischemic cardiomyopathy\n* Stroke or seizure within 6 months of enrollment\n* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form\n* Any serious concurrent medical conditions that may make the patient non-evaluable or put the patient's safety at risk, per the discretion of the treating physician or PI\n* Patients with a positive PCR test for hepatitis B virus or hepatitis C virus indicating active infection. Patients with positive serologic testing indicating exposure will need confirmatory testing by PCR.\n* Patients who are seropositive for HIV\n* Prior or concurrent malignancy, except for the following:\n\n  * Adequately treated basal cell or squamous cell skin cancer or in-situ carcinoma.\n  * Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.\n  * Localized prostate cancer (N0M0):\n\n    * with a Gleason score of ≤6, treated within the last 24 months or untreated and under surveillance,\n    * with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence; or\n    * any history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence per the discretion of the treating physician or PI\n  * Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n  * Breast cancer: adequately treated lobular carcinoma in situ, or ductal carcinoma in situ, or history of localized breast cancer and receiving anti-hormonal agents and considered to have a very low risk of recurrence.\n  * Any other cancer from which the subject has been disease free for \\> 3 years prior to study entry, or considered cured with minimal risk of disease recurrence.\n* Prior treatment with CAR-T\n* Prior allogeneic stem cell transplant\n* Major cardiac surgery within 8 weeks prior to cilta-cel; all other major surgery within 4 weeks prior to cilta-cel.\n* Patients who are pregnant or breastfeeding\n* Subjects with following physical and laboratory test findings:\n\n  * Absolute neutrophil count \\\u003C 1 x 109\u002FL without growth factor support within 1 week, or absolute neutrophil count \\\u003C 0.5 x 109\u002FL for patients with documented Duffy-null blood typing\n  * Platelets \\\u003C 50 x 109\u002FL without transfusion support within 1 week\n  * Creatinine clearance \\\u003C 30 ml\u002Fmin according to the Cockroft-Gault formula:\n\n    * Female CrCl = \\[(140 - age in years) x weight in kg x 0.85\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]\n    * Male CrCl = \\[(140 - age in years) x weight in kg x 1.00\\] \u002F \\[72 x serum creatinine in mg\u002Fdl\\]\n  * Total bilirubin ≥ 2 x ULN (≥ 3 x ULN if documented Gilbert's syndrome)\n  * AST or ALT ≥ 3x ULN\n  * Corrected serum calcium \\> 13.5 mg\u002FdL\n* Are also excluded:\n\n  * Prisoners or subjects who are involuntarily incarcerated\n  * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness",{"count":229,"type":23},30,"OBSERVATIONAL","This is an observational umbrella protocol evaluating toxicities after CAR-T therapy with ciltacabtagene autoleucel (cilta-cel) for RRMM, with a goal to identify key inflammatory features contributing to toxicities, define non-invasive biomarkers to guide clinical monitoring, and evaluate treatment strategies to reduce morbidity for patients. Toxicities of interest will include neurotoxicity, hematologic, and gastrointestinal events. Patients planned to receive cilta-cel as part of their standard of care multiple myeloma therapy will be enrolled. All patients will have baseline evaluation at the time of leukapheresis and cilta-cel infusion, as well as longitudinal blood, bone marrow, cerebrospinal fluid (CSF), and gastrointestinal (GI) samples collected for translational assessment. Patients who experience toxicities of interest as evaluated by their clinical team will undergo additional evaluation and sample collection, as guided by the involved organ system (e.g. CSF for neurologic toxicity, endoscopic evaluation with colonic biopsies for colitis), with monitoring for resolution of symptoms on therapy. Additional patients from Mount Sinai or other centers \\[University of California San Francisco (UCSF), Memorial Sloan Kettering Cancer Center (MSKCC)\\] who have previously been or will be treated with cilta-cel and are participating in institutional biobanks will similarly be included for ongoing sample collected per local protocols, and samples from patients experiencing toxicities of interest will be sent to Mount Sinai for analysis to supplement the prospective cohort.",[233],"Multiple Myeloma",[235,236,237,238,239,240],"multiple myeloma","myeloma","car-t toxicity","neurotoxicity","car-t","cilta-cel","2026-08-06",{"date":192,"type":42},{"date":244,"type":42},"2026-07-10",{"date":246,"type":23},"2029-06-18",{"name":48,"class":49},{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":24,"phases":257,"briefSummary":258,"conditions":259,"keywords":262,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":73},"100632184","cgm-after-discharge-from-hospital-100632184","NCT07510386","CGM After Discharge From Hospital","Continuous Glucose Monitoring for Post-discharge Diabetes Management","Inclusion Criteria:\n\n* Adult 18 years or older.\n* Inpatient treatment for type 2 or steroid induced diabetes during hospitalization, with plan for insulin use after discharge.\n\nExclusion Criteria:\n\n* Type 1 diabetes\n* Plan for discharge to rehabilitation\u002Fskilled nursing\u002Fhospice facility\n* Contra-indication to sensor placement\n* Pregnancy",{"count":256,"type":23},64,[26],"This is an investigator initiated prospective, randomized controlled trial which aims to compare two groups of patients with either type 2 or steroid-induced diabetes who are discharged with insulin. The intervention group will use the Libre 3 Plus continuous glucose monitoring (CGM) system at discharge, while the control group will use blinded CGM and fingerstick monitoring. Both the intervention and control groups will wear the sensor for 28 days post discharge and participate in telehealth diabetes management visits. The target enrollment for the study is 65 participants and participants are expected to be in the study for up to 35 days.",[260,261],"Type 2 Diabetes","Steroid-induced Diabetes",[263,264],"discharge","CGM","2026-08-05",{"date":192,"type":42},{"date":268,"type":23},"2026-09-30",{"date":270,"type":23},"2026-11",{"name":48,"class":49},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":279,"minAge":19,"maxAge":280,"enrollmentInfo":281,"targetDuration":4,"studyType":24,"phases":283,"briefSummary":284,"conditions":285,"keywords":288,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":299,"locationsCount":73},"100607871","high-intensity-focused-ultrasound-hifu-ablation-for-treatment-of-prostate-tissue-in-bladder-outlet-obstruction-100607871","NCT07194187","High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction","HIFU for BOO","Inclusion Criteria:\n\n* Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH.\n* Prostate size \\> 30cc and \\\u003C 80cc as measured by transrectal ultrasound (TRUS) or MRI within 1 year prior to treatment.\n* A documented history of refusal to take medical therapy, inadequate or failed response to medical therapy, or contraindications to medical therapy.\n* Initial baseline International Prostate Symptom Score (IPSS) greater than or equal to 12 which denotes moderate to severe symptoms.\n* Baseline peak urinary flow rate (Qmax) of less than 15 mL\u002Fs1\n* Baseline serum creatinine \\\u003C 2 mg\u002FdL within 30 days prior to surgery\n* Mental capacity, willingness, and ability to sign a study specific informed consent form\n\nExclusion Criteria :\n\n* BMI \\> 42\n* Patients with an obstructing prostatic median lobe as measured by baseline preliminary imaging and\u002For confirmed on cystoscopy examination.\n* Patients with latex allergies which would permit latex catheterization perioperatively as silicone catheterization is not recommended during HIFU treatment.\n* Patients with extensive calcification in the treatment area of the prostate as measured by preoperative imaging with TRUS or MRI and as evaluated by hospital radiology or the principal investigator. Extensive calcification is defined as where the calcification in posterior peripheral zone, which may interfere with experimental treatment procedure, and it is determined by hospital radiologist and further assessed by the PI.\n* Patient unable to stop anticoagulants, antiplatelet agents, or NSAIDS (including aspirin \\> 100mg) prior to treatment which is standard of care.\n* Patients using immunosuppressants including corticosteroids (except inhalants) who are unable to withhold medications prior to treatment which is standard of care.\n* Known and documented coagulopathy or platelet disorder\n* Contraindication to both general and spinal anesthesia which are standard of care.\n* Severe illness that would prevent complete study participation.\n* History of active or prior treatments for current\u002Fsuspected PCa.\n* Diagnosis of polyneuropathy\n* Bladder calculi or bladder diverticulum (pouch size \\> 20% of full bladder size)\n* Active infection, including urinary tract infection or prostatitis.\n* Evidence of hydronephrosis on imaging.\n* Pre-op urinary catheter uses daily.\n* Previous urinary tract surgeries such as, but not limited to prior surgery for LUTS, urinary diversion, artificial urinary sphincter, or penile prosthesis.\n* Diagnosis of clinically significant urethral stricture, meatal stenosis, severe phimosis, or bladder neck contracture\n* Known damage to the external urinary sphincter.\n* Open heart surgery or cardiac arrest \\\u003C 180 days prior to the date of informed consent\n* Known illicit substance abuse.\n* Use of anticholinergics (specifically for bladder problems). Use of general anticholinergics is allowed if they do not have documented adverse urinary side effects.\n* Dementia or psychiatric conditions which prevent them from completing the required follow up.\n* Prior pelvic radiotherapy\n* Participation in another ongoing investigational study that could affect responses.\n* Unwillingness to accept a transfusion should it be required.\n* No members of vulnerable populations will be included in our study.\n* History or current diagnosis of chronic prostatitis.\n* Diagnosis or prior treatment for chronic pelvic pain syndrome.","MALE","80 Years",{"count":282,"type":23},17,[26],"Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH).\n\nThe primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline.\n\nThe secondary objectives of this study are as follow:\n\n* To assess any adverse events related to the procedure or device.\n* To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone\n* To assess the patient's post operative pain level at different post op time points.\n* To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline.\n* To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op.\n* To assess changes in patients' sexual function at different post op time points.\n\nThe hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.",[286,287],"Bladder Outlet Obstruction","BPH",[289,290,291,292,293,294],"High-intensity focused ultrasound","Interventional","Single Arm","benign prostatic hyperplasia treatment","International Prostate Symptom Score","Device Safety",{"date":192,"type":42},{"date":195,"type":23},{"date":298,"type":23},"2029-06-30",{"name":48,"class":49},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":58,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":327,"locationsCount":120},"100585193","phase-2-atomoxetine-in-melanocortin-obesity-syndrome-100585193","NCT06899178","Atomoxetine in Melanocortin Obesity Syndrome","A Phase 2, Double Blind, Randomized, Placebo-controlled Crossover Trial to Evaluate the Efficacy and Safety of Atomoxetine in Adults With Melanocortin Obesity Syndrome","MCOS","Inclusion criteria:\n\n* Age 6 years and above\n* Documented MC4R variant classified as pathogenic, likely pathogenic, or variant of uncertain significance per ACMG criteria. If testing was done in a research lab, it will be confirmed by a CLIA-approved lab prior to randomization.\n* Obesity defined as BMI ≥30 kg\u002Fm2 in adults or ≥95th percentile for age and sex in children\n\nExclusion criteria:\n\n* Use of atomoxetine, viloxazine (another selective norepinephrine-reuptake inhibitor), methylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, phentermine, or any other stimulant medication in the past 30 days. If on other ADHD medications, such as guanfacine and clonidine, must be on a stable dose for \\>3 months.\n* Weight loss \\>5% in the past 3 months.\n* Initiation of new weight loss program, including diet or medications. If on weight loss medications, must be on a stable dose for \\>3 months.\n* Inability to swallow capsules.\n* History of hypersensitivity to atomoxetine.\n* Narrow angle glaucoma.\n* History of pheochromocytoma.\n* Uncontrolled Stage 2 hypertension (≥95th percentile + 12 mmHg or \\>140\u002F90, whichever is lower) at screening. If on antihypertensive medication, must be on stable dose for \\>3 months.\n* Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \\>3x upper limit of normal)\n* Uncontrolled asthma requiring albuterol more than once weekly over the past 3 months\n* History of a cardiac arrhythmia (not including bradycardia)\n* Current use of monoamine oxidase inhibitors\n* Pregnancy or intention to become pregnant during the next year\n* History of Major Depressive Disorder in the past 2 years, lifetime history of suicide attempt, history of any suicidal behavior in the past month, history of other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder)\n* PHQ-9 score is ≥15 or suicidal ideation of type 4 or 5 (C-SSR) in the past month\n* Unable to comply with study procedures in the opinion of the investigator","6 Years",{"count":310,"type":23},20,[132],"This is a phase 2 randomized placebo-controlled crossover trial to determine the safety and efficacy of atomoxetine for treating obesity caused by loss-of-function variants in the melanocortin-4 receptor (MC4R), the most common cause of genetic obesity disorders. Atomoxetine was selected for this pilot trial because it has been shown to increase brain-derived neurotrophic factor (BDNF) within the central nervous system and in peripheral circulation. Targeting BDNF is a specific strategy for treating MC4R abnormalities because BDNF functions as a downstream mediator of MC4R signaling.",[314,306],"Melanocortin Obesity Syndrome",[316,317,318,319,320,321],"Obesity","BDNF","MC4R","Atomoxetine","Energy balance","Weight loss","2026-08-04",{"date":324,"type":42},"2026-08-07",{"date":195,"type":23},{"date":71,"type":23},{"name":48,"class":49},{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":58,"minAge":335,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":24,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":353,"leadSponsor":355,"locationsCount":73},"100650299","safety-and-feasibility-of-dbs-for-bipolar-depression-100650299","NCT07745374","Safety and Feasibility of DBS for Bipolar Depression","Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches","Inclusion Criteria:\n\n* Age 22-70 years\n* Ability to provide written informed consent\n* Primary diagnosis of Bipolar I Disorder confirmed by SCID-5\n* Current major depressive episode (MDE) of at least 12 months duration\n* Stable control of mania for a minimum of 1 year\n* Agreement to remain on current anti-mania medication regimen\n* Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline\n* Young Mania Rating Scale (YMRS) score \\\u003C12 at screening and baseline\n* Treatment-resistant depression: failure to respond to at least 4 adequate trials of antidepressant treatment in the current episode. Antidepressant treatments include: Medications (Must include 2 antidepressant medications from different pharmacological classes), Psychotherapy, ECT, repetitive transcranial magnetic stimulation (rTMS), IV ketamine or intra-nasal esketamine.\n* All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit.\n* Able to provide informed consent\n* English-speaking\n* Deemed suitable surgical candidate by neurosurgical evaluation\n* Under care of treating psychiatrist willing to collaborate with study team\n* Able to reside in New York Metropolitan area during first 6 months or willing\u002Fable to travel monthly to study site\n* Provision of at least two emergency contacts age ≥22 residing within reasonable proximity\n\nExclusion Criteria\n\n* Current manic or hypomanic episode (YMRS ≥12)\n* Rapid cycling pattern (≥4 mood episodes in the past 12 months)\n* Active suicidal ideation with intent or plan\n* Suicide attempt within six months prior to baseline\n* Current psychotic symptoms\n* Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder\n* History (current and\u002For lifetime) of one or more schizophrenia-spectrum or other psychotic disorders including: schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and major depressive disorder with psychosis (unipolar or bipolar), and\u002For psychotic depression (unipolar or bipolar) (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder)\n* Substance use disorder (moderate or severe) within 6 months\n* Presence of any type of dementia \u002F Major Neurocognitive Disorder \u002F significant cognitive impairment interfering with study participation\n* Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant\n* Subject has a diagnosis of Substance Use Disorder as defined by the DSM-V without sustained remission (12 months or longer)\n* History of borderline or severe personality disorder, as determined by clinical judgment, which would significantly interfere with a subject's participation in the study\n* Active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder\n* Cognitive or psychiatric deficit (e.g., amnesia, delirium) that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments\n* Current or lifetime history of psychotic features in any major depressive episode (MDE)\n* Treatment with another investigational device or investigational drugs\n* Contraindications to MRI (metallic implants, claustrophobia unmanageable with anxiolytics)\n* Contraindications to general anesthesia or neurosurgery\n* Significant structural brain abnormalities precluding safe electrode placement\n* Active infection or immunocompromised state\n* Active unstable medial condition (diabetes, heart disease, hypertension, cancer, endocrine)\n* BMI \\>35; and\u002For CRP \\>3\n* Coagulopathy or anticoagulation that cannot be safely interrupted\n* Pregnancy or planning pregnancy during study period\n* Women of childbearing potential unwilling to use effective contraception\n* Prisoners or institutionalized individuals\n* Decisionally impaired individuals (unless previously consented when capacitated)\n* Special status patients (employees, VIPs, celebrities, public figures) unless consented before special status known","22 Years","70 Years",{"count":338,"type":23},5,[26],"This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.",[342,343],"Bipolar I Disorder","Bipolar Depression",[345,346,347,348,349],"deep brain stimulation","safety","subcallosal cingulate","local field potentials","Bipolar 1 depression","2026-08-03",{"date":322,"type":42},{"date":69,"type":23},{"date":354,"type":23},"2028-10",{"name":48,"class":49},{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":24,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":373,"leadSponsor":375,"locationsCount":73},"100650360","knee-positioning-after-total-knee-replacement-100650360","NCT07747116","Knee Positioning After Total Knee Replacement","The Effects of Postoperative Positioning in Knee Flexion Versus Usual Care After Total Knee Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Males and females; Age \\>18 years\n* Scheduled for elective primary unilateral total knee arthroplasty\n* The planned arthroplasty is secondary to physician-confirmed diagnosis of knee osteoarthritis\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Patients with a history of chronic opioid use or chronic pain disorders\n* Patients with a history of bleeding disorders\u002Fcoagulopathy\n* Patients receiving a total knee replacement secondary to trauma, avascular necrosis, tumor, or Charcot arthropathy\n* Patients scheduled to undergo multiple procedures simultaneously\n* Patients with cognitive impairment or inability to consent independently",{"count":107,"type":23},[26],"Many total knee replacements are performed each year, but there is no clear recommendation regarding knee positioning following this surgery. While the surgical knee is usually positioned in a straight position immediately after surgery, there may be benefits of positioning it in a partially bent position. A trial will compare the outcomes of two groups of patients: a) those whose knees are positioned in a partially bent position for a few hours after surgery and b) those who receive usual care where the knee is most likely positioned in a straight position. The investigators are looking to see whether knee motion and pain differ for patients in the two groups.",[367],"Knee Arthroplasty",[369],"Knee Flexion","2026-07-30",{"date":265,"type":42},{"date":44,"type":23},{"date":374,"type":23},"2029-02",{"name":48,"class":49},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":24,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":398,"locationsCount":73},"100503268","rectus-sheath-block-in-cardiac-surgery-100503268","NCT05833048","Rectus Sheath Block in Cardiac Surgery","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n  1. Adults 18-85 years old\n  2. Scheduled to undergo cardiac procedures involving chest tubes\n  3. Male or female\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. ASA class V\n  2. Urgent or emergent surgery\n  3. Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)\n  4. History of substance abuse or chronic opioid use\n  5. Patient refusal or inability to consent","85 Years",{"count":384,"type":23},75,[26],"This is a prospective, randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of a type of peripheral nerve block, Rectus Sheath Block.\n\n1. Does the rectus sheath block decrease opioid consumption postoperatively after cardiac surgery?\n2. Does the rectus sheath block decrease VAS pain scores postoperatively after cardiac surgery? Study participants will be assigned to receive either rectus sheath block or no block.",[388,389],"Cardiac Disease","Postoperative Pain",[391,392],"cardiac surgery","regional anesthesia",{"date":394,"type":42},"2026-07-31",{"date":396,"type":42},"2024-07-29",{"date":167,"type":23},{"name":48,"class":49},{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":18,"minAge":59,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":24,"phases":407,"briefSummary":408,"conditions":409,"keywords":412,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":73},"100642361","phase-4-remimazolam-versus-dexmedetomidine-for-sedation-during-neuraxial-100642361","NCT07651956","Remimazolam Versus Dexmedetomidine for Sedation During Neuraxial","Remimazolam Versus Dexmedetomidine for Procedural Sedation During Neuraxial Anesthesia Placement For Scheduled Cesarean Delivery","Inclusion Criteria:\n\n* Pregnant patient scheduled for cesarean delivery\n* ≥ 18 years old\n* ≥ 37 weeks gestational age\n\nExclusion Criteria:\n\n* Pregnant patients \\\u003C 18 years old\n* Pregnant patients \\\u003C 37 weeks gestational age\n* Has known hypersensitivity to benzodiazepines or dexmedetomidine\n* Has history of chronic benzodiazepine use or misuse",{"count":107,"type":23},[83],"Patients presenting for a scheduled cesarean delivery who require a neuraxial anesthetic will be randomized to receive intravenous remimazolam or dexmedetomidine for procedural sedation during the placement of their spinal or epidural anesthesia.",[410,411],"Pregnant People","Anxiety",[413,414,415],"Anxiolysis","Remimazolam","Dexmedetomidine","2026-07-25",{"date":418,"type":42},"2026-07-28",{"date":44,"type":23},{"date":421,"type":23},"2028-05",{"name":48,"class":49},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":430,"targetDuration":432,"studyType":230,"phases":4,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":220},"100649382","natural-history-of-madd-100649382","NCT07734090","Natural History of MADD","Natural History of Multiple Acyl-CoA Dehydrogenase Deficiency (MADD)","Inclusion Criteria:\n\n* Have a biochemical and\u002For molecular diagnosis of Multiple Acyl-CoA Dehydrogenase Deficiency (MADD), as confirmed by a study investigator\n* Provision of signed and dated informed consent form (and assent when applicable) from subject or subject's legal representative\n\nExclusion Criteria:\n\n\\- Presence of a major unrelated condition",{"count":431,"type":23},50,"5 Years","The objective of this study is to conduct a longitudinal, observational investigation to determine the natural history of Multiple Acyl-CoA Dehydrogenase Deficiency (MADD), delineate the spectrum of its clinical features and their progression, identify biomarkers, and develop and validate patient reported outcomes.",[435],"Multiple Acyl-CoA Dehydrogenase Deficiency","2026-07-24",{"date":438,"type":42},"2026-07-29",{"date":440,"type":23},"2026-07",{"date":442,"type":23},"2031-07",{"name":48,"class":49},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":452,"enrollmentInfo":453,"targetDuration":455,"studyType":230,"phases":4,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":73},"100608152","the-challenger-registry-100608152","NCT07197840","The CHALLENGER Registry","Chronic Subdural Hematoma Treated With Numen SILK Coiling of Middle Meningeal Artery","CHALLENGER","* Age 18-98 years inclusively\n* Per CT of the head, (one of the following):\n\n  * Unilateral convexity cSDH measuring at least 10 mm in thickness OR\n  * Bilateral cSDH if only one side is considered for treatment and the contralateral side is asymptomatic and \\\u003C 5 mm in thickness.\n* cSDH at least 2\u002F3 isodense or hypodense, verified on axial CT slice used to measure the thickness of the qualifying cSDH\n* Qualifying baseline head CT performed within the 14 days prior to treatment\n* Patient or legally authorized representative agrees to be participated in the study and provides written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization\n\nExclusion Criteria:\n\n* Secondary cause apart from trauma for the qualifying SDH, such as an underlying vascular abnormality or tumor\n* Bilateral cSDH with unknown origin of symptoms\n* Participants who underwent prior embolization of either MMA\n* Tentorial or interhemispheric SDH\n* mRS \\>4\n* On tranexamic acid\n* Intractable coagulation dysfunction or abnormal platelet count and function (pre-operative International Normalized Ratio \\[INR\\] \\> 1.5 and\u002For platelet count \\\u003C 80109\u002FL)\n* Anatomical variations that may affect the safety of MMA embolization (e.g., prominent middle MMA ophthalmic artery anastomosis)\n* Known contraindications to angiography\n* Known intolerance to occlusion procedures\n* Known vascular anatomy (small artery size) or blood flow (high vascular resistance peripheral to the feeding arteries) that precludes catheter placement or coil embolization\n* Known presence of collateral vessel pathways potentially endangering normal territories or cranial nerves during embolization.\n* Known large diameter arteriovenous shunt, i.e., where the blood does not pass through an arterial\u002Fcapillary\u002Fvenous transition but directly from an artery to a vein or presence of patent extra-to-intracranial anastomoses (where study embolization devices could pass directly into the internal carotid artery, vertebral artery, or intracranial vasculature) that cannot be addressed with coil embolization.\n* Patient has a known active systemic infection or sepsis\n* Patient is pregnant, planning to become pregnant, or lactating\n* Life expectancy of less than 6 months due to comorbid terminal conditions\n* Concurrent participation in another research protocol for investigation of an experimental therapy\n* Known or suspected to not be able to comply with the study protocol","98 Years",{"count":454,"type":23},100,"180 Days","The study is a multi-center prospective, single-arm, post-market study evaluating the efficacy and radiologic and functional outcomes associated use of the Numen SILK coils for Middle Meningeal Artery (MMA) embolization following Chronic Subdural Hematoma (cSDH) compared to surgical evacuation or medical management alone.\n\nChronic subdural hematoma is a collection of blood between the dural mater and the brain. It typically develops over time in older adults or people on anticoagulant medication. Blood slowly accumulates over time and often becomes encapsulated by a fibrous membrane over weeks or months, which can lead to the gradual development of symptoms. Middle Meningeal Artery embolization (MMAE) through coiling provides a minimally invasive option for cSDH treatment and prevention of reaccumulation and recurrence.",[458],"Chronic Subdural Hematoma",{"date":418,"type":42},{"date":461,"type":42},"2025-11-20",{"date":463,"type":23},"2028-03-01",{"name":48,"class":49},{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":472,"targetDuration":4,"studyType":24,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":73},"100597515","phase-4-atezolizumab-and-bevacizumab-in-combination-with-y90-radioembolization-in-hcc-for-liver-transplant-100597515","NCT07059494","Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization in HCC for Liver Transplant","A Feasibility Clinical Trial of Atezolizumab and Bevacizumab in Combination With Y^90 Radioembolization for Patients With Hepatocellular Carcinoma (HCC) for Liver Transplantation","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Age ≥18 years at time of signing Informed Consent Form\n* Ability to comply with the study protocol\n* Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) that is histologically or cytologically confirmed\n* Availability of a representative tumor specimen that is suitable for determination of PD-L1 status via central testing. A formalin-fixed paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 slides (15 slides preferred) slides containing unstained, freshly cut, serial sections should be submitted along with an associated pathology report prior to study enrollment. If archival tumor tissue is unavailable or is determined to be unsuitable for required testing, tumor tissue must be obtained from a biopsy performed at screening. Availability of a representative tumor specimen for exploratory biomarker research. Newly diagnosed, biopsy-proven hepatocellular carcinoma (HCC) either outside of the Milan Criteria (MC), or within the MC, with high risk disease as defined by alpha-fetoprotein (AFP) ≥400 ng\u002FmL, and also fulfilling the criteria below.\n\n  1. Within MC with AFP ≥ 400 ng\u002Fml\n\n     1. single lesion (≤5cm) or 3 lesions (≤3cm)\n     2. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging\n     3. Child-Pugh Score of A\u002FB7 (without ascites)\n  2. UNOS-DS Protocol\n\n     1. HCC exceeding UNOS T2 criteria but meeting one of the following:\n\n        * Single lesion ≤ 8 cm\n        * 2 or 3 lesions each ≤ 5 cm with the sum of the maximal tumor diameters ≤8 cm\n        * or 5 lesions each ≤ 3 cm with the sum of the maximal tumor diameters ≤ 8 cm\n     2. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging\n     3. Child-Pugh Score of A\u002FB7 (without ascites)\n  3. Beyond UNOS-DS Liver Only Protocol a. HCC exceeding UNOS-DS criteria by any of the following:\n\n     * HCC tumor number\n     * HCC tumor size\n     * Total HCC tumor diameter b. Absence of vascular invasion or extra-hepatic disease based on cross-sectional imaging c. Child-Pugh Score of A\u002FB7 (without ascites)\n* Measurable disease, or non-measurable but evaluable disease, per RECIST v1.1 criteria\n* Must meet institutional standards for proteinuria (Urinalysis (pH, specific gravity, glucose, protein, ketones, and blood); dipstick permitted\n* Eligible for treatment with Y\\^90 and atezolizumab plus bevacizumab\n* ECOG performance status of 0-1\n* Life expectancy \\> 6 months\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:\n\n  * ANC 1.5 ≥ 10\\^9\u002FL (1500\u002FµL) without granulocyte colony-stimulating factor support, with the following exception:\n  * Participants with benign ethnic neutropenia (BEN): ANC \\\u003C 1.3 x 10\\^9\u002FL (1300\u002FμL) BEN (also known as constitutional neutropenia) is an inherited cause of mild or moderate neutropenia that is not associated with any increased risk for infections or other clinical manifestations. BEN is referred to as ethnic neutropenia because of its increased prevalence in people of African descent and other specific ethnic groups.\n\n    * Lymphocyte count ≥ 0.5 x 10\\^9\u002FL (500\u002FµL)\n    * Platelet count ≥ 100 x 10\\^9\u002FL (100,000\u002FµL) without transfusion\n    * Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL)\n  * Participants may be transfused to meet this criterion.\n\n    * AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 upper limit of normal (ULN)\n    * Serum bilirubin ≤ 1.5 x ULN with the following exception:\n  * Participants with known Gilbert disease: serum bilirubin ≤ 3 x ULN\n\n    * Serum creatinine ≤ 1.5 x ULN\n    * Serum albumin ≥ 25 g\u002FL (2.5 g\u002FdL)\n    * For participants not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN\n    * For participants receiving therapeutic anticoagulation: stable anticoagulant regimen\n* Absent or controlled HIV, HCV, and HBV o Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count ≥ 200\u002FμL, and have an undetectable viral load\n* Negative serum pregnancy test within 14 days prior to the initiation of study treatment for participants of childbearing potential.\n* Since adequate studies have not been performed in animals to determine whether Y\\^90 affects fertility in males or females has teratogenic potential or has other adverse effects on the fetus, this product should not be administered to pregnant or nursing women unless it is considered that the benefits to be gained outweigh the potential hazards. Ideally the use of this radioactive device in women of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.\n* Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods\n\nExclusion Criteria:\n\n* AFP ≥ 1000 ng\u002Fml\n* Pathologically mixed tumors, vascular invasion or extra-hepatic disease based on cross-sectional imaging\n* History of leptomeningeal disease\n* Uncontrolled tumor-related pain\n\n  o Participants requiring pain medication must be on a stable regimen at study entry.\n* Severe pulmonary disease, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) o Participants with indwelling catheters (e.g., PleurX®) are allowed\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency, including, but not limited to, uncontrolled HIV, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (protocol lists a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\\u003C 10 percent of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * There has been no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan\n\n  o History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 12 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Major surgical procedure, other than for diagnosis or standard HCC care, within 4-6 weeks prior to initiation of study treatment, or during the study\n* Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to initiation of study treatment\n\n  o Placement of a vascular access device should be at least 2 days prior to initiation of study treatment\n* History of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year overall survival (OS) rate \\> 90 percent), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, bladder cancer, carcinoma in situ, or Stage I uterine cancer\n* Severe active infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, active infection requiring IV antibiotics at the time of initiation of study treatment, or any active infection that could impact participant safety\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n\n  o Participants receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior allogeneic stem cell, solid organ, or multi-organ transplantation\n* Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n  * Participants who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study.\n  * Participants who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Known allergy or hypersensitivity to any component of the study therapy\n* Prior locoregional or systemic therapy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.\n* Inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n* History of hypertensive crisis or hypertensive encephalopathy\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months prior to randomization\n* History of Grade ≥ 4 venous thromboembolism\n* History or evidence upon physical or neurological examination of central nervous system involvement\n* History of Grade ≥ 2 hemoptysis (defined as ≥ 2.5 mL of bright red blood per episode) within 1 month prior to screening\n* History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding (i.e., in the absence of therapeutic anticoagulation)\n* History of abdominal fistula, GI perforation, intra-abdominal abscess, or active GI bleeding within 6 months prior to randomization\n* Serious, non-healing wound, active ulcer, or untreated bone fracture\n* Current or recent (\\\u003C 10 days prior to initiation of study treatment) use of aspirin (\\> 325 mg\u002Fday), or clopidogrel (\\> 75 mg\u002Fday) Note: The use of full-dose oral or parenteral anticoagulants for therapeutic purpose is permitted as long as the INR and\u002For aPTT is within therapeutic limits (according to institution standards) within 7 days prior to initiation of study treatment and the participant has been on a stable dose of anticoagulants for ≥ 2 weeks prior to initiation of study treatment. Prophylactic use of anticoagulants is allowed. However, the use of direct oral anticoagulant therapies such as dabigatran (Pradaxa®) and rivaroxaban (Xarelto®) is not recommended due to bleeding risk.",{"count":178,"type":23},[83],"A single institution, single arm, two-cohort feasibility trial to evaluate the combination of locoregional Y\\^90 therapy with systemic atezolizumab and bevacizumab, in participants presenting with hepatocellular carcinoma (HCC) 1) within Milan Criteria (MC) with AFP ≥ 400 ng\u002Fml as a means of bridge therapy prior to transplant, 2) beyond the Milan Criteria (MC) (within USCF DS criteria and all comers), as a means of downstaging prior to liver transplantation.",[476],"Hepatocellular Carcinoma",{"date":418,"type":42},{"date":479,"type":42},"2026-03-26",{"date":481,"type":23},"2028-08-01",{"name":48,"class":49},{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":4,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":24,"phases":491,"briefSummary":492,"conditions":493,"keywords":497,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":505,"leadSponsor":507,"locationsCount":73},"100546738","virtual-reality-vr-self-hypnosis-software-100546738","NCT06398847","Virtual Reality (VR) Self-Hypnosis Software","An Open-label Study of Self-hypnosis Software for Virtual Reality for the Treatment of HIV-associated Chronic Pain - a Development and Usability Study","Patient Eligibility\n\nInclusion Criteria:\n\n* Adults age ≥18\n* Confirmed diagnosis of HIV, currently on a stable antiretroviral regimen ≥ 90 days.\n* Documentation of chronic pain associated with HIV for≥90 days\n* Stable pain management regimen ≥90 days, or no pain treatments ≥90 days\n* Average pain intensity of 3 or greater on the NRS of the mean daily scores reported between Visit 1 and Visit 2\n* Access to the internet via smartphone, computer, or tablet 7. Fluent in English\n* Capable of giving informed consent and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n* A co-occurring medical or psychiatric condition which would make participation in the study or complicate measurement of changes associated with the intervention.\n* Concurrent participation in another investigational protocol for pain treatment\n* A psychiatric disorder, medical condition, or other life circumstance, which in the opinion of the PI, would contraindicate attendance at sessions, or make it unlikely that the participant could successfully complete the study procedures.\n* Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines, or other neurological conditions contraindicating the use of virtual reality devices.\n* A medical condition predisposing prospective participant to nausea or dizziness 6. Lack of stereoscopic vision or severe hearing impairment\n* Injury to eyes, face, or neck that impedes using the VR device\n* If participant has access to personal VR gear for gaming or other purposes at home, participant fails to agree not to use these personal VR gear during the course of the protocol.\n* Currently pregnant or planning to become pregnant during the study period",{"count":178,"type":23},[26],"This single-site study of self-hypnosis software using an off-the-shelf virtual reality (VR) device (OculusGo™) to determine the software's safety, usability, and preliminary efficacy in pain relief for HIV-associated chronic pain patients. This is funded under the i Prism Funding through Mount Sinai Innovations.",[494,495,496],"Musculoskeletal Pain","Neuropathic Pain","Neuralgia",[498,499,500,501],"HIV chronic pain","Self-hypnosis","virtual reality software","non-drug treatment for chronic pain",{"date":503,"type":42},"2026-07-27",{"date":479,"type":42},{"date":506,"type":23},"2027-06-30",{"name":48,"class":49},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":514,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":516,"targetDuration":455,"studyType":230,"phases":4,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":73},"100615347","chronic-subdural-hematoma-embolization-with-detachable-coils-100615347","NCT07291427","Chronic Subdural Hematoma Embolization With Detachable Coils","Safety and Efficacy of Chronic Subdural Hematoma Embolization With Detachable Coils","SEED","Inclusion criteria:\n\n* Age ≥ 18\n* Patients experiencing unilateral or bilateral non-acute subdural hematoma confirmed by CT imaging. Acute on Chronic or mixed density hematoma allowed.\n* A clinical decision has been made to use coiling and\u002For embolics as treatment, with or without surgical debridement, independently as per standard of care and prior to enrollment in the study.\n* Signed informed consent obtained by patient or Legal Authorized Representative (LAR)\n\nExclusion criteria:\n\n* Primary acute SDH\n* Prior MMAE in target territory\n* Premorbid mRS \\> 3\n* Common carotid stenosis \\>70% or prior carotid stent placement\n* Significant medical contraindication to angiography (kidney failure\u002Fdisease)\n* Anatomical variations that would make MMA embolization difficult or unsafe\n* Currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints\n* Pregnancy\n* Life expectancy ≤ 1 year",{"count":107,"type":23},"This is a prospective, multi-center, post market registry study designed to evaluate the safety and efficacy of treatment with Balt coils in patients with chronic subdural hematoma (cSDH).",[519],"Chronic Subdural Hemorrhage (cSDH)",[521,522,523],"Subdural hemorrhage","Coils","Middle meningeal artery","2026-07-23",{"date":436,"type":42},{"date":527,"type":42},"2026-06-02",{"date":529,"type":23},"2028-09-01",{"name":48,"class":49},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":24,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":555,"startDateStruct":557,"completionDateStruct":559,"leadSponsor":561,"locationsCount":220},"100471454","phase-2-the-sinai-robotic-surgery-trial-in-hpv-related-oropharyngeal-squamous-cell-carcinoma-sirs-20-trial-100471454","NCT05419089","The Sinai Robotic Surgery Trial in HPV-related Oropharyngeal Squamous Cell Carcinoma (SIRS 2.0 Trial)","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed and identified resectable primary OPSCC with positive p16 immunohistochemistry, defined as strong and diffuse nuclear and cytoplasmic staining in \\> 70% of tumor cells. Immunohistochemistry must be performed or reviewed at the central laboratory. P16 status may be determined prior to consent and must be confirmed by surgical specimen if a biopsy is unavailable. HR-HPV status and postoperative cfHPVDNA testing must be performed and resulted prior to treatment assignment. Tissue from the primary site must be available for biomarker studies after surgery.\n* Patients enrolled in the trial must have pre-surgery baseline cfHPVDNA using the NavDX assay (Naveris, Cambridge, MA). Detectable baseline cfHPVDNA copy number is defined as ≥ 10 fragments\u002FmL and is required for inclusion in the trial.\n* Undetectable cfHPVDNA after surgery. All patients should have a repeat cfHPVDNA test within 1 to 5 weeks post-operatively and prior to treatment assignment. Undetectable cfHPVDNA is defined as \\\u003C 5 fragments\u002FmL.\n* AJCC 7th edition early and intermediate stage (T1N0-2B, T2N0-2B) (non-matted) disease without evidence of distant metastases or gross extranodal extension.\n* Age ≥ 18 years at screening\n* No previous surgery, radiation therapy, or chemotherapy for head and neck cancer (other than excision\u002Fincisional biopsy of the primary site, excisional\u002Fincisional nodal biopsy, or tonsillectomy) is allowed at time of study entry.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No active tobacco use (≥1cigarette or cigarette-equivalent per day within the last 5 years) and no cumulative smoking history of \\>20 pack years. 1 cigar = 4 cigarette-equivalent exposure\n* Ability to understand and the willingness to sign a written informed consent document.\n* Participants must have adequate bone marrow, hepatic and renal functions as defined below:\n\n  * Platelet count ≥ 90 x 109\u002Fl.\n  * Hemoglobin ≥ 10 g\u002Fdl (may achieve by transfusion).\n  * Renal function: eGFR ≥ 50 ml\u002Fmin\n\nExclusion Criteria\n\n* Age \\\u003C 18 years at screening\n* Pregnant or breast-feeding women.\n* Previous or current malignancies at other sites, except for adequately treated in situ carcinoma of the cervix, basal or squamous cell carcinoma of the skin, thyroid cancer, prostate cancer treated with surgery\u002Fradiotherapy, ductal carcinoma in situ of the breast treated with surgery\u002Fradiotherapy, or other cancer curatively treated and with no current evidence of disease for at least 3 years.\n* Other serious illnesses or medical conditions including but not limited to:\n\n  * Unstable cardiac disease despite treatment or myocardial infarction within 6 months prior to study entry.\n  * History of significant neurologic or psychiatric disorders including severe dementia or poorly controlled seizures\n  * Active clinically significant uncontrolled infection\n  * Active peptic ulcer disease defined as unhealed or clinically active\n  * Active drug addiction including alcohol, cocaine or intravenous drug use defined as occurring within the 6 months preceding diagnosis\n  * Severe chronic obstructive pulmonary disease, defined as being associated with a hospitalization for pneumonia within 12 months of diagnosis.\n  * Prior organ transplant\n  * Interstitial lung disease\n  * Concurrent treatment with any other anti-cancer therapy\n  * Participation in an investigational therapeutic drug trial within 30 days of study entry. Participation in additional investigational radiation studies will exclude participation in SIRS. Participation in non-therapeutic, non-oncologic investigational studies (i.e. pain control studies, nutritional studies, etc.) will be allowed amongst SIRS participants, provided there is no alteration of treatment planning, oncologic therapy, or surveillance, and additional studies comply with SIRS safety criteria and stopping rules as outlined in the SIRS protocol.\n  * Active hepatitis C by history\n* Advanced nodal stage (AJCC 7th edition N2C, N3) or surgically unresectable disease or disease that cannot be fully resected, unequivocal radiographic extranodal extension, unequivocal radiographic or clinical supraclavicular or matted metastatic disease, \\> 3 unequivocally radiographic pathologic cervical nodes.\n* Non-HR-HPV subtype on initial biopsy or final pathology.\n* 5 or more positive nodes, irrespective of size, on final pathology.\n* p16 or HPV negative OPSCC as determined by IHC and PCR or ISH, respectively.\n* Undetectable or \\\u003C 10 fragments\u002FmL baseline cfHPVDNA prior to surgery.\n* Autoimmune disease treated with chemotherapy agents or anti TNF agents within the last 2 years.\n* Detectable repeat cfHPVDNA 1-5 weeks postoperatively via the NavDX assay, defined as \\> 5 fragments\u002FmL.",{"count":538,"type":23},83,[132],"The purpose of this study is to determine whether treatment of HPV-related oropharyngeal squamous cell carcinoma in patients with undetectable postoperative HPV circulating tumor DNA (cfHPVDNA) with transoral robotic surgery (TORS) alone can result in cancer control and survival comparable to those previously reported with standard therapy. The protocol includes patients with only with low or intermediate pathologic risk factors following surgery with detectable pre-surgery cfHPVDNA and undetectable post-surgery cfHPVDNA.\n\nThe hope is that with this approach, the long-term complications from chemotherapy and radiation can be reduced.",[542],"HPV-positive Oropharyngeal Squamous Cell Carcinoma",[544,545,546,547,548,549,550,551,552,553],"Oropharyngeal squamous cell carcinoma","OPSCC","Human papillomavirus","Transoral robotic surgery","TORS","HPV","p16","ctDNA","circulating tumor DNA","cfHPVDNA","2026-07-21",{"date":556,"type":42},"2026-07-22",{"date":558,"type":42},"2022-07-12",{"date":560,"type":23},"2029-06",{"name":48,"class":49},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":12,"sex":58,"minAge":569,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":24,"phases":572,"briefSummary":573,"conditions":574,"keywords":576,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":586,"locationsCount":587},"100326741","effect-of-music-therapy-on-infants-with-neonatal-abstinence-syndrome-100326741","NCT03533985","Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome","The Effect of Music Therapy on Neonates Diagnosed With Neonatal Abstinence Syndrome: A Pilot Study","Inclusion Criteria:\n\nInfants who meet the following inclusion criteria will be eligible to participate in the study irrespective of race, religion, ethnicity, or gender:\n\n* Admitted to the NICU immediately postpartum\n* Gestational age 28 weeks or older\n* No identified hearing disorder\n* Do not have a diagnosed developmental disability (i.e. Down Syndrome)\n* Do not have Fetal Alcohol Syndrome\n* Medically cleared to participate in the study by nurse or neonatologist\n* Parent or legal guardian able\u002Fwilling to give consent \\& complete the PBQ (Postpartum Bonding Questionnaire)\n\nExclusion Criteria:\n\n* Admitted to the NICU at any time other than immediately postpartum\n* Gestational age \\\u003C28 weeks old\n* Has an identified hearing disorder\n* Has diagnosed developmental disability (i.e. Down syndrome)\n* Has Fetal Alcohol Syndrome\n* Is not medically cleared to participate in the study by the nurse or neonatologist\n* Parent or legal guardian unable\u002Funwilling to give consent","28 Weeks",{"count":571,"type":23},200,[26],"This study examines the effects of 6 different music therapy interventions on outcomes for neonates diagnosed with Neonatal Abstinence Syndrome.",[575],"NAS",[577,578,579,580,581],"Neonatal Abstinence Syndrome","Music therapy","Attachment","Music medicine","Multi-modal stimulation",{"date":556,"type":42},{"date":584,"type":42},"2017-11-01",{"date":167,"type":23},{"name":48,"class":49},6,{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":12,"sex":58,"minAge":59,"maxAge":4,"enrollmentInfo":594,"targetDuration":4,"studyType":24,"phases":595,"briefSummary":596,"conditions":597,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":554,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":73},"100234343","the-impact-of-group-singing-on-patients-with-stroke-and-their-personal-caregivers-100234343","NCT02328573","The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers","Inclusion Criteria:\n\n* Stroke victim, regardless of level of stroke\n\nExclusion Criteria:\n\n* None",{"count":22,"type":23},[26],"The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care",[598],"Stroke and Aphasia",{"date":556,"type":42},{"date":601,"type":42},"2014-04-04",{"date":603,"type":23},"2026-11-13",{"name":48,"class":49},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":58,"minAge":4,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":230,"phases":4,"briefSummary":613,"conditions":614,"keywords":616,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":650,"lastUpdatePostDateStruct":651,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":657},"100377781","clinical-and-basic-investigations-into-congenital-disorders-of-glycosylation-100377781","NCT04199000","Clinical and Basic Investigations Into Congenital Disorders of Glycosylation","Inclusion Criteria:\n\n* Individuals with a genetically, enzymatically, or molecularly confirmed diagnosis of CDG or NGLY1 deficiency\n\nExclusion Criteria:\n\n* None",{"count":612,"type":23},500,"The purpose of this research is to study the natural history of congenital disorders of glycosylation and its causes and treatments.",[615],"Congenital Disorders of Glycosylation",[617,618,615,619,620,621,622,623,624,625,626,627,628,629,630,631,632,633,634,635,636,637,638,639,640,641,642,643,644,645,646,647,648,649],"CDG","CDDG","Congenital Disorders of Deglycosylation","ALG1","ALG3","ALG6","ALG12","ALG13","COG6","DPAGT1","DPM1","EDEM3","MAN1B1","MPDU1","MPI","NGLY1","PGAP3","PGM1","PIGA","PIGG","PIGN","PIGS","PIGT","PMM2","SLC35A2","SLC35C1","SLC39A8","SRD5A3","SSR4","FUT8","GALNT2","MAN2B2","VMA21","2026-07-19",{"date":554,"type":42},{"date":653,"type":42},"2019-10-08",{"date":655,"type":23},"2030-07-31",{"name":48,"class":49},12,""]