[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of California, Irvine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":626},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,84,0,25,[9,47,75,108,128,153,175,195,221,240,274,299,322,352,374,404,427,445,466,486,508,534,558,580,601],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100054012","phase-2-metformin-in-pseudomyxoma-peritonei-secondary-to-appendiceal-mucinous-neoplasms-100054012",false,"NCT07693452","Metformin in Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms","Use of Metformin in Patients With Pseudomyxoma Peritonei Secondary to Appendiceal Mucinous Neoplasms","Key Inclusion Criteria (complete details available in protocol):\n\n* Patients with clinical diagnosis of pseudomyxoma peritonei (PMP) secondary to presumed appendiceal mucinous neoplasms (AMNs) with recurrent\u002Frefractory disease s\u002Fp cytoreductive surgery(CRS)\u002Fhyperthermic intraperitoneal chemotherapy (HIPEC), unresectable disease, or without planned CRS\u002FHIPEC\n* Age ≥18 years\n* ECOG performance status ≤2\n\nKey Exclusion Criteria (complete details available in protocol):\n\n* Patients with a clinical diagnosis of PMP secondary to presumed AMNs with resectable disease who are planned to undergo CRS\u002FHIPEC\n* Patients currently taking metformin for another medical indication\n* Patients with a prior adverse event to administration of metformin","ALL","18 Years",{"count":20,"type":21},15,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a pilot, open-label clinical trial determining the feasibility of metformin therapy in subjects with pseudomyxoma peritonei (PMP) secondary to appendiceal mucinous neoplasms (AMNs).",[27,28],"Appendiceal Mucinous Neoplasm","Pseudomyxoma Peritonei",[27,28,30,31,32,33],"Pseudomyxoma Peritoneal","PMP","AMNs","Metformin","RECRUITING","2026-07-09",{"date":37,"type":38},"2026-07-13","ACTUAL",{"date":40,"type":38},"2026-06-18",{"date":42,"type":21},"2029-07",{"name":44,"class":45},"University of California, Irvine","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100398793","phase-2-cabozantinib-combined-with-ipilimumabnivolumab-and-tace-in-patients-with-hepatocellular-carcinoma-100398793","NCT04472767","Cabozantinib Combined With Ipilimumab\u002FNivolumab and TACE in Patients With Hepatocellular Carcinoma","Phase 2 Study of Cabozantinib Combined With Ipilimumab\u002FNivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment","Inclusion Criteria:\n\n* Histologic or radiographic diagnosis of hepatocellular carcinoma\n* At least one lesion amenable to TACE treatment\n* Child-Pugh A-B7 (B7 based on Albumin allowed)\n* Not a candidate for resection or transplantation\n* Age ≥ 18 years.\n* Performance status: ECOG performance status ≤2\n* Must have at least one measurable lesion (either untreated or progressed after previous locoregional treatment)\n* Adequate organ and marrow function as defined below:\n\n  1. Leukocytes ≥ 2,000\u002FmcL\n  2. absolute neutrophil count ≥ 1000\u002FmcL\n  3. platelets ≥ 60,000\u002Fmcl\n  4. total bilirubin within normal institutional limits\n  5. AST(SGOT)\u002FALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present\n  6. creatinine \\\u003C1.5ULN\n  7. hemoglobin ≥ 8 g\u002FdL\n  8. Serum albumin ≥ 2.8 g\u002FdL\n  9. Urine protein\u002Fcreatinine ration (UPCR) ≤ 1 mg\u002Fmg\n* The effects of cabozantinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 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\nBased on its mechanism of action, ipilimumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with ipilimumab and for 3 months following the last dose of ipilimumab.\n\nBased on its mechanism of action, nivolumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with nivolumab and for 5 months following the last dose of nivolumab.\n\n1\\. 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\n1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n2. 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\n   * Life expectancy of greater than 3 months\n   * Ability to swallow tablets\n   * Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Any type of previous systemic anti-cancer treatment\n* All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline\n* Any locoregional treatment for HCC within 3 months\n* Vp4 or Vp3 portal vein thrombus\n* Extrahepatic disease\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, cabozantinib or other agents used in study.\n* Concomitant anticoagulation with coumarin agents (eg, warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., rivaroxaban), or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following:\n\n  1. Prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose low molecular weight heparins (LMWH).\n  2. Therapeutic doses of LMWH in subjects with a screening platelet count \\> 100,000\u002FμL, without known brain metastases, and who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* The subject has prothrombin time (PT)\u002FINR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.\n* Uncontrolled intercurrent illness including, but not limited to, the following conditions:\n\n  1. ongoing or active infection\n  2. symptomatic congestive heart failure\n  3. uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment\n  4. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose\n  5. unstable angina pectoris\n  6. cardiac arrhythmia\n  7. evidence of tumor invading GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n  8. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.\n\n     Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose.\n  9. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose.\n  10. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n  11. Lesions invading any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.\n  12. Other clinically significant disorders that would preclude safe study participation:\n\n      1. Serious non-healing wound\u002Fulcer\u002Fbone fracture\n      2. Uncompensated\u002Fsymptomatic hypothyroidism\n      3. Moderate to severe hepatic impairment (Child-Pugh B or C)\n  13. psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Prior treatment with cabozantinib\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.\n\nCorrected QT (QTc) = QT \u002F ∛RR\n\nQT: duration of QT interval RR: duration of RR interval\n\nNote: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.\n* Inability to comply with study and follow-up procedures as judged by the Investigator\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* Has fibrolamellar HCC\n* Has received prior cytotoxic, biologic or other systemic anticancer therapy including investigational agents within 4 weeks prior to randomization.\n* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Has received a live vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Has severe hypersensitivity (Grade ≥ 3) to nivolumab or cabozantinib and\u002For any of their excipients.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n* Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":55,"type":21},35,[24],"This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab\u002Fnivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.",[59,60],"Hepatocellular Carcinoma","HCC",[59,60,62,63,64,65,66],"Cabozantinib","Ipilimumab","Nivolumab","TACE","transarterial chemoembolization","2026-06-29",{"date":69,"type":38},"2026-07-01",{"date":71,"type":38},"2020-08-07",{"date":73,"type":21},"2027-09-01",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100609081","secondary-cervical-cancer-prevention-of-vulnerable-women-with-hpv-and-hiv-co-infection-in-india-100609081","NCT07209917","Secondary Cervical Cancer Prevention of Vulnerable Women With HPV and HIV Co-infection in India","Secondary Cervical Cancer Prevention of Vulnerable Women With Human Papillomavirus (HPV) and Human Immunodeficiency Virus (HIV) Co-infection in India","SAKHI","Inclusion Criteria:\n\n1. WLH, 25 - 50 years of age; based on HIV-based guidelines;\n2. Receiving ART for \\> 12 months to ensure medication stabilization, and ensure any impact on the cervical cancer outcomes will not be attributed solely to recent ART initiation, as validated by an ART card given to all ART patients;\n3. Screened as HPV positive by RT-PCR (Reverse Transcription Polymerase Chain Reaction) for oncogenic genes; and assessed to be VIA negative;\n4. Have not participated in Phase I Formative Study.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women due to hormonal and dietary guideline differences;\n2. Women older than age 50. These women will be immediately referred to a gynecology specialist.","FEMALE","25 Years","50 Years",{"count":87,"type":21},348,[89],"NA","Cervical cancer (CC) remains one of the most common malignancies among women in India, with nearly 100,000 women diagnosed annually and over 60,000 preventable deaths annually. With high-risk human papillomavirus (HR-HPV) as the causative agent for CC, one risk factor that places women at high risk for CC is human immunodeficiency virus (HIV), as impaired immune response against Human papillomavirus (HPV) may result in persistent HR-HPV infection, a critical risk factor for progression of HPV-related cervical oncogenesis. Progression of precancerous lesions among women living with HIV (WLH) is also associated with: 1) lack of HPV screening; 2) high levels of depressive symptoms and stigma; and 3) malnutrition, which negatively impacts the activation and proliferation of immune cells. Yet programs that offer WLH with comprehensive services focused on HPV screening and psychological and nutritional support are almost non-existent, and the gap is critical. Nutrition plays an integral role in relationship to HPV\u002FHIV co-infection, as demonstrated by an increased risk of HR-HPV associated with poor nutrition; nutritional deficiencies are likewise linked to cervical intra-epithelial neoplasia. The immunological effect of malnutrition may also be exacerbated among WLH due to elevated energy demands of chronic immune activation; worsened with HPV\u002FHIV co-infection. Further, depressive symptoms (aka depression for brevity) partially mediate the effect of food insecurity on HIV viral suppression. In our completed ASHA-Nutrition R01 study of antiretroviral (ART) adherence, the investigators trained lay community health workers, named Accredited Social Health Activist (ASHA), to improve the health of 600 rural WLH by providing emotional support, skill-building, nutrition education, and\u002For protein-enriched food supplements. In that study, our intervention, co-delivered by our trained ASHA, and guided by nurses, led to increased CD4+ T cell recovery and improved anthropometric and psychosocial outcomes. The investigators found that ASHA support plus protein supplements and nutritional education were significantly associated with improved CD4 counts and increased lean mass at 18 months (P \\\u003C 0.001), as well as significant improvements in depression, ART adherence, social support and internalized stigma. In our sub study, CC screening of 598 of these WLH revealed that 13% were found to have abnormal cervical lesions and 4 (1%) had squamous CC. Preliminary evidence also revealed that nutritional supplements may be associated with a 40% reduction in the risk of abnormal cervical lesions (adjusted odds ratio \\[aOR\\] = 0.60), with an association between serum albumin and reduced risk of abnormal lesions (aOR= 0.39).\n\nWith a focus on secondary prevention of CC, the investigators hope to mitigate the link between HR-HPV persistence and risk of CC as well as improve the health of women co-infected with HPV\u002FHIV (W-Co-V). Our stellar team plans to build upon our prior ASHA-Nutrition intervention, using formative research to refine a nurse-led, ASHA co-delivered, nutrition-enhanced SAKHI HPV intervention, adapted for W-Co-V. This will be followed by a randomized controlled trial (RCT), assessing the efficacy of our refined comprehensive, multifaceted SAKHI HPV intervention, as compared with an enhanced Standard of Care (SOC+) (usual care + 3 sessions \\[wellness, basic nutrition and HPV\u002FHIV health promotion\\]) among 348 high-risk co-infected women to prevent CC while remaining engaged in the HIV treatment cascade, and managing nutritional health. Recruited participants will be individually randomized in a 1:1 ratio into the two study arms. Our Primary outcome is HR-HPV persistence (2 positive tests for the same HR-HPV type, separated by 12-18 months). The two aims incorporating RCT interventions are as follows:\n\nAim 2. To evaluate the efficacy of SAKHI HPV intervention among 348 W-Co-V on the primary outcome (HR-HPV persistence) as compared to the Enhanced Standard of Care (SOC+) program. H2: Compared to the SOC+ participants, SAKHI participants will have lower rates of HR-HPV persistence.\n\nAim 3. Assess the impact of the SAKHI program secondarily on: 1) HIV indices (HIV viral load; CD4 count); 2) Nutritional index (serum albumin) at 6-, 12-, and 18-months.",[92,93,94],"Cervical Cancer","Human Papillomavirus (HPV) Infection","Human Immunodeficiency Virus (HIV) Infection",[96,97,98],"Cervical Cancer Prevention","HPV-HIV Co-Infection","ASHA-Nutrition","2026-06-23",{"date":101,"type":38},"2026-06-26",{"date":103,"type":38},"2026-02-01",{"date":105,"type":21},"2029-04-30",{"name":44,"class":45},3,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":83,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":46},"100560600","the-effects-of-core-shamanism-in-fibromyalgia-100560600","NCT06579261","The Effects of Core Shamanism in Fibromyalgia","Inclusion Criteria for Fibromyalgia participants:\n\n* Female\n* Over 18 and under 75 years of age.\n* Fibromyalgia patients and satisfies the 2016 Fibromyalgia Diagnostic Criteria for the classification of FM.\n* Mean recalled pain over the last seven days (7-day recall) greater than or equal to 4 on a 10 cm Visual Analog Scale (VAS) for pain; 7-day recall.\n* Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.\n* Able to travel to the study site to receive shamanic treatments up to twice weekly.\n* Understanding and willing to complete all study procedures.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in english.\n\nExclusion Criteria:\n\n* Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.\n* History of head injury with substantial loss of consciousness\n* Peripheral neuropathy of known cause that interferes with activities of daily living.\n* Routine daily use of opioid analgesics, marijuana, or history of substance abuse.\n* Stimulant medications, such as those used to treat Attention Deficit Disorder (ADD)\u002FAttention-deficit\u002Fhyperactivity disorder (ADHD). (e.g., amphetamine\u002F dextroamphetamine \\[Adderall®\\], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.\n* Concurrent participation in other therapeutic trials.\n* Use of as needed (PRN) over the counter (OTC) pain medications (Nonsteroidal anti-inflammatory drugs (NSAIDs), etc.) on day of electroencephalogram (EEG) testing.\n* Use of PRN opioid analgesics 48 hours prior to electroencephalogram (EEG) testing.\n* Pregnant or nursing. A pregnancy test will be given prior to electroencephalogram (EEG) sessions.\n* Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).\n* Contraindications to EEG methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material.\n* Any impairment, activity or situation that is in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.\n* Sufficient knowledge of Shamanism techniques that may bias participant outcomes.\n* Presence of factors that may preclude the safe use of the Shamanism intervention.\n* History vascular surgery in lower limbs or current lower limb vascular dysfunction.\n* Presence of uncontrolled cardiovascular disease.\n* Subjects with Worker's Compensation, Workman's Compensation, civil litigation or disability claims pertinent to the subject's fibromyalgia; current involvement in out-of-court settlements for claims pertinent to the subject's fibromyalgia; or currently receiving monetary compensation as a result of any of the above.\n* Inability or unwillingness of an individual to give written informed consent.","75 Years",{"count":7,"type":21},[89],"This study aims to determine the feasibility of a shamanism intervention for patients with fibromyalgia, acquire efficacy data to determine if Shamanism reduces clinical pain and other common symptoms associated with fibromyalgia, and determine if the Shamanism intervention changes heart rate electrocardiogram (ECG), breathing rate, and brain wave electroencephalogram (EEG) outcomes in fibromyalgia patients and shamanic practitioners.\n\nThe investigators hypothesize that 80% of individuals will complete at least 80% of study visits, clinical pain severity and\u002For interference will be significantly reduced following the Shamanic intervention, and lung, heart, and\u002For brain activity will be altered with the Shamanic intervention and also become more synchronized between Shamanic Practitioners (SPs) and patients during the course of treatment.",[119],"Fibromyalgia",[121],"fibromyalgia chronic pain",{"date":99,"type":38},{"date":124,"type":38},"2024-08-01",{"date":126,"type":21},"2026-12",{"name":44,"class":45},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":84,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":46},"100484038","phase-4-treatment-of-menieres-disease-with-migraine-medications-100484038","NCT05582837","Treatment of Meniere's Disease With Migraine Medications","Treatment of Meniere's Disease With Nortriptyline-Topiramate Stepwise Regimen: A Randomized Double-Blinded Clinical Trial","Inclusion Criteria:\n\n1. Patients with active or frequent Meniere's Disease.\n2. Male or female between the ages of 25 to 85 years.\n3. Subject must be compliant with the medication and attend study visits.\n4. Must be able to read and write in the English language to provide consenting.\n\nExclusion Criteria:\n\n1. Pregnancy will result in automatic exclusion from the study. A urine pregnancy test to rule out pregnancy for all women who are of childbearing potential.\n2. Subjects with history of surgery for Meniere's Disease.\n3. Subject with history of an adverse reaction to medication being prescribed.\n4. Subject suffers from a medical condition or has history that may be concerning to the investigator's clinical opinion.\n5. Subjects with psychosis.\n6. Subjects with neurological neoplasm.\n7. All contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.","85 Years",{"count":137,"type":21},40,[139],"PHASE4","Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that interfere with the patient's quality of life. Despite the large economic and emotional impact of symptoms in MD patients, there is no FDA-approved medication to treat this debilitating condition. As such, our objective in this study is to evaluate the therapeutic potential of novel medications in treating MD that have previously shown astonishing promise in our clinical practice.",[142],"Ménière",[144],"Meniere's Disease, medication, randomized, trial, migraine","2026-06-17",{"date":147,"type":38},"2026-06-22",{"date":149,"type":38},"2022-08-01",{"date":151,"type":21},"2027-12-30",{"name":44,"class":45},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":46},"100559974","analgesic-response-to-opioids-in-patients-with-fibromyalgia-after-conventional-acupuncture-versus-sham-acupuncture-100559974","NCT06571110","Analgesic Response to Opioids in Patients With Fibromyalgia After Conventional Acupuncture Versus Sham Acupuncture","Inclusion Criteria:\n\n* Are 18 - 80 years old\n* have been diagnosed with Fibromyalgia for more than 6 months\n* Are already using chronic, continuous opioid therapy, including but not limited to the use of Hydrocodone (Norco), Oxycodone (Percocet), morphine, methadone or Tylenol #3 daily\n* Have moderate to excruciating pain at baseline, determined by a 5 or greater score on the Visual Analogue Scale (VAS)\n\nExclusion Criteria:\n\n* Are younger than 18 or older than 80 years old\n* Have been diagnosed with a Substance Use Disorder (SUD)\n* Pregnant\n* Have an active litigation or worker's compensation case\n* Have an active mental health diagnosis, such as bipolar disorder, psychosis, or suicidal ideation\n* Are prescribed and actively using low dose Naltrexone . Have tried acupuncture in the last 6 months","80 Years",{"count":161,"type":21},45,[89],"This study aims to see whether acupuncture can help fibromyalgia patients by giving them acupuncture treatment and seeing whether acupuncture helps enhance the effects of an opioid.",[119],[166],"Acupunture","2026-06-11",{"date":169,"type":38},"2026-06-15",{"date":171,"type":38},"2025-03-15",{"date":173,"type":21},"2027-12-01",{"name":44,"class":45},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":22,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":46},"100325038","acoustic-and-electrical-stimulation-for-the-treatment-of-tinnitus-100325038","NCT03511807","Acoustic and Electrical Stimulation for the Treatment of Tinnitus","Inclusion Criteria:\n\n1. 18 years or older\n2. Male or female\n3. Tinnitus present for 6 months or more\n4. Adequate command of English to reliably describe the unusual sensory percepts provided by electrical stimulation, and to complete surveys.\n5. For patients undergoing electrical stimulation via a cochlear implant, they should have a cochlear implant prior to enrollment (not applicable for acoustic stimulation)\n\nExclusion Criteria:\n\n1. Aged less than 18 years\n2. Active illicit drug use, alcohol dependence\n3. Treatable cause of tinnitus\n4. History of psychosis\n5. Abnormalities of the ear canal or ear drum\n6. Chronic middle ear disease\n7. Subjects on medications known to cause tinnitus (aspirin, ibuprofen, naproxen) which could not be stopped will be excluded.\n8. Pregnant or breastfeeding.",true,{"count":183,"type":21},100,[89],"Tinnitus, or ringing in the ears, affects 10% to 30% of the population. Of those, 20% have tinnitus bothersome enough to seek medical attention. In many people, tinnitus can significantly affect the quality of life. At this point in time, there is no effective treatment or cure available for tinnitus.\n\nIt has been found that electrical stimulation of the inner ear can reduce and in some cases eliminate tinnitus. The purpose of this research is to investigate both acoustic and electrical stimulation of the inner ear as a possible treatment of tinnitus.\n\nIn both acoustic and electrical testing conditions, the subjects will be instructed to be familiar with a 0-10 ranking scale of loudness. In acoustic testing, the stimulus will be presented through headphones in a noiseless environment, and the subject will be asked to report on the loudness of the presented sound and the level of the tinnitus at 20-second intervals. If the subject cannot perceive the presence of the tinnitus, a value of zero will be assigned. A typical sound will be presented for 3 to 6 minutes. Loudness will be reported for 1 to 4 minutes after stimulus offset to measure the presence and duration of residual inhibition.\n\nElectrical stimulation will be delivered to the inner ear in three ways, 1. using a cochlear implant (implant placed in the inner ear to replace hearing function), 2. Using an electrode placed in the ear canal, and 3. using a small needle inserted through the ear drum. Various electrical signals will be used to evaluate the reduction in the tinnitus perception by the subject. The subjects will rate the loudness of the tinnitus before, during, and after the electrical signal. Surveys will be used to evaluate the tinnitus loudness and the quality of life of the subjects. Hearing tests will be used before and after the procedures. The long term goal of this research is to develop a device to treat tinnitus in people who can hear and to develop programs for cochlear implants that help treat tinnitus in deaf people.",[187],"Tinnitus","2026-06-09",{"date":167,"type":38},{"date":191,"type":38},"2017-01-01",{"date":193,"type":21},"2032-11",{"name":44,"class":45},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":46},"100514214","phase-4-pharmacotherapy-in-conjunction-with-lifestyle-counseling-for-management-of-weight-regain-after-bariatric-surgery-100514214","NCT05975580","Pharmacotherapy in Conjunction With Lifestyle Counseling for Management of Weight Regain After Bariatric Surgery","PROJECT-BARI","Inclusion Criteria:\n\n1. Male and female subjects aged 18-70 years\n2. Had sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) at least 18 months ago\n3. Weight regain of ≥5% relative to post-surgery nadir weight\n4. Body mass index (BMI) ≥30 kg\u002Fm2 or ≥27 kg\u002Fm2 with weight-related comorbidities\n5. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry\n6. Must be able to provide written informed consent\n\nExclusion Criteria:\n\n1. Type 1 diabetes\n2. Insulin-dependent type 2 diabetes\n3. Fasting plasma glucose (FPG) ≥240 mg\u002FdL\n4. Uncontrolled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and\u002For diastolic blood pressure (DBP) ≥100 mm Hg on the average of three seated measurements after being at rest for at least 5 minutes\n5. History of significant (as determined by the investigator) and unstable cardiovascular disease including coronary artery disease, arrhythmias, severe congestive heart failure, or stroke\n6. Use of monoamine oxidase inhibitors, current or within 2 weeks\n7. Hyperthyroidism or other significant thyroid disease\n8. Angle-closure glaucoma\n9. Agitated states\n10. History of drug abuse within the past year\n11. Known hypersensitivity or idiosyncrasy to sympathomimetic amines\n12. Severe hepatic disease (non-alcoholic fatty liver disease or non-alcoholic steatohepatitis without portal hypertension or cirrhosis is acceptable)\n13. End-stage renal disease\n14. History of nephrolithiasis\n15. Serum triglycerides ≥500 mg\u002FdL\n16. Cancer, not in remission, within the past 2 years except for adequately treated basal cell, squamous cell skin cancer, or in-situ cervical cancer\n17. History of psychosis or bipolar disorder\n18. Suicidal ideation or unstable\u002Funtreated major depressive disorder within the past year\n19. Use of antidepressant medication that has not been at stable dose for at least 3 months\n20. Hospital Anxiety and Depression Scale (HADS) score of ≥11 for depression or anxiety items\n21. Binge Eating Scale (BES) score of ≥27\n22. Alcohol use disorder within the past year\n23. Epilepsy\n24. Currently taking phentermine or topiramate or the combination, or products containing these drugs\n25. Currently taking stimulants (e.g., Attention Deficit Hyperactivity Disorder medications)\n26. Current use of prescription or over-the-counter weight loss drugs or supplements\n27. Taking prescription or over-the-counter drugs or products, which in the opinion of the PI, could be associated with significant effects on body weight\n28. Planning additional bariatric surgery procedures in the next 13 months\n29. History of revisional bariatric surgery (revisional surgery after adjustable gastric banding is acceptable)\n30. Currently participating in another weight loss program or have plans to participate in the next 13 months\n31. Smoking cessation within the previous 3 months or plans to quit smoking in the next 13 months\n32. Pregnant or breastfeeding or planning pregnancy in the coming 13 months\n33. History of, or any existing condition that, in the opinion of the Principal Investigator, would interfere with the study outcomes or place the subject at unacceptable risk by participating in the study","70 Years",{"count":204,"type":21},120,[139],"This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.",[208],"Obesity",[210,211,212,213],"Bariatric surgery","Weight regain","Antiobesity drugs","Treatment of weight regain","2026-06-05",{"date":188,"type":38},{"date":217,"type":38},"2023-08-29",{"date":219,"type":21},"2028-01-31",{"name":44,"class":45},{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":237,"leadSponsor":239,"locationsCount":46},"100633487","phase-2-fianlimabcemiplimab-as-totalneoadj-the-tnt-formelanoma-100633487","NCT07527325","Fianlimab&Cemiplimab as TotalNeoadj The (TNT) ForMelanoma","Fianlimab and Cemiplimab as Total Neoadjuvant Therapy (TNT) For Melanoma","Inclusion Criteria:\n\n* ≥18 years at the time of signing informed consent form (ICF) and able to independently complete informed consent. A certified translator must be used in the completion of informed consent for non-English speaking individuals.\n* Patients must have surgically resectable, macroscopic Stage IIIB-D cutaneous melanoma or oligometastatic resectable stage IV (M1a, M1b, and M1c) melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria. Patients are eligible at the time of the initial diagnosis or recurrence after previous surgery. Patients should have \\> 1 RECIST measurable lesion.\n* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at initial screening.\n* Life expectancy of at least 12 weeks.\n* Adequate bone marrow, liver, and renal function:\n* Hemoglobin \\>8.0 g\u002FdL\n* Platelets \\>75\u002Fmm3\n* ANC \\>1.5\u002Fmm3\n* Creatinine Clearance \\> 30mL\u002Fmin\n* AST and ALT less than 3 times the Upper Limit of Normal. participants with Gilbert's syndrome are excluded if total bilirubin \\> 3.0 × ULN; or direct bilirubin \\> 1.5 × ULN\n* Total Bilirubin \\\u003C 3.1.\n* Albumin ≥ 3.0 g\u002FdL\n* Absolute neutrophil count ≥ 1.5 × 109\u002FL\n* Absolute lymphocyte count ≥ 0.5 × 109\u002FL\n* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment.\n* Females of childbearing potential and males must be willing and able to use a highly effective method of contraception to avoid pregnancy for the duration of the study and for at least 6 months after the last dose of study treatment. Acceptable means of contraception are listed in the fianlimab institutional brochure.\n* Male participants must be willing to abstain from donating sperm from the time of enrollment until 6 months after administration of study interventions.\n\nExclusion Criteria:\n\n* Participants with visceral, bone, or brain metastases.\n* Participants with a local recurrence in scar or surgical bed of the primary melanoma as the sole site of disease.\n* Participants with N1a or N2a only disease.\n* Participants with a diagnosis of acral, ocular or mucosal melanoma.\n* Participants with a history of a malignant disease that can interfere with interpretation of study results.\n* Participants with previous treatment with investigational or standard immunotherapy for melanoma or other malignancy.\n* Patients with a history of myocarditis.\n* Patients with a TnT or troponin I (TnI) \\> 2x institutional ULN at baseline. Patients with Troponin T (TnT) or troponin levels between \\> 1 to 2x ULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\> 1 to 2x ULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on the medical judgement in the patient's best interest.\n* Participants with known untreated or symptomatic central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Known hypersensitivity to the active substances or to any of the excipients.\n* Participants with a known history of chronic viral infections as indicated below.\n* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \\> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.\n* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.\n* HIV infection with CD4 count \\\u003C200\u002Fmicroliter as measured within screening time period. Patients with HIV infectious should be on combination antiretroviral medication.\n* History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (eg, cellulitis, pneumonia, septicemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n* Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents except for the following: . The following are non-exclusionary: vitiligo, childhood asthma that has resolved, residual hypothyroidism that requires only hormone replacement, psoriasis not requiring systemic treatment.\n* Participants with a history of allogeneic tissue\u002Fsolid organ transplant.\n* Live vaccine within 30 days of the planned administration of a study drug.\n* Positive pregnancy test during screening. Pregnant or lactating women are prohibited from enrolling in this study.\n* Participants must not have any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration, impair the ability of the participant to receive protocol therapy, or interfere with the interpretation of study results.",{"count":55,"type":21},[24],"This is a phase II, open label clinical trial determining efficacy of Fianlimab in combination with Cemiplimab in subjects with Melanoma. These are subjects who will have surgery to remove their cancer.",[232],"Melanoma (Skin)","NOT_YET_RECRUITING","2026-06-03",{"date":214,"type":38},{"date":69,"type":21},{"date":238,"type":21},"2030-02-01",{"name":44,"class":45},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":46},"100638426","early-phase-1-feasibility-study-on-the-effect-of-a-methionine-reduced-diet-on-serum-levels-in-pts-w-solid-tumors-100638426","NCT07628634","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Pts w\u002F Solid Tumors","Feasibility Study on the Effect of a Methionine-Reduced Diet on Serum Levels in Patients With Solid Tumors","Inclusion Criteria:\n\n* Age: Subjects must be 18 years of age or older.\n* Diagnosis: Has a diagnosis of metastatic, recurrent, or unresectable solid tumors.\n* Life Expectancy: Subjects must have an expected life expectancy of at least 3 months.\n* Performance Status: Subjects must have an ECOG performance status of 0-2.\n* Organ Function: Subjects must have adequate organ function, as determined by the investigator through review of standard labs.\n* Pregnancy and Contraception: Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days prior to study enrollment and must agree to use adequate contraception throughout the study period and for 30 days after the last dose of study treatment. Female patients who are considered not to be of childbearing potential must have a history of being postmenopausal (with a minimum of 1 year without menses), tubal ligation, or hysterectomy.\n* Dietary Compliance: Subjects must be willing and able to comply with the methionine-reduced diet as prescribed by the study protocol.\n* Informed Consent: Subjects or Legally Authorized Representatives (LAR) must provide written informed consent prior to any study-specific procedures, indicating that they understand the purpose of the study and are willing to comply with its requirements.\n* Able to receive systemic standard of care cancer therapy.\n\nAdditional criteria specifically for the glioma population:\n\n* Diagnosis: Histopathological proven diagnosis: a) newly diagnosed grade 2-3 glioma or b) all grades for recurrent glioma.\n* Treatment: Subjects must be able to receive radiation therapy and\u002For chemotherapy as a part of their treatment.\n\nExclusion Criteria:\n\n* Brain Metastases: Subjects with uncontrolled or symptomatic brain metastases. Subjects with brain metastases that have been treated, are asymptomatic, and patients who require steroids are eligible.\n* Significant Clinical Illness: Subjects with uncontrolled significant clinical illnesses, including but not limited to: a) Active infections requiring systemic therapy. b) Severe cardiovascular conditions such as recent myocardial infarction (within 6 months), uncontrolled angina, congestive heart failure (NYHA class III or IV), or significant arrhythmias. (c) Uncontrolled diabetes.\n* Significant Amino Acid\u002FMetabolic Illnesses: Subjects with severe or inherited illnesses that affect metabolism of amino acids or disrupt nutrient absorption, including but not limited to: a) Severe liver disease, such as cirrhosis or severe hepatic insufficiency, that may have compromised ability to metabolize amino acids. b) Inherited metabolic disorders, such as homocystinuria or other disorders affecting sulfur amino acid metabolism, that may have potential metabolic imbalances. c) Severe gastrointestinal disorders, such as active inflammatory bowel disease (IBD), short bowel syndrome, or other conditions that significantly impair nutrient absorption, that may lead to nutritional deficiencies and gastrointestinal complications.\n* Recent Surgery: Major surgery within 4 weeks of randomization (biopsies are acceptable per investigator judgement)\n* Concurrent Malignancies: Subjects with another malignancy that requires active treatment during the study period or is expected to interfere with the study intervention.\n* Pregnancy or Lactation: Female subjects who are pregnant or breastfeeding.\n* Malnutrition: Subjects with severe malnutrition or significant nutritional deficiencies per investigator's discretion.\n* Substance Abuse: Subjects with a history of substance abuse or dependency within the past 6 months that, in the opinion of the investigator, would interfere with adherence to study requirements.\n* Subjects with chronic kidney disease with advanced stages 3b or higher.\n* Psychiatric Disorders: Subjects with psychiatric disorders that would interfere with the ability to give informed consent or adhere to study requirements per investigator judgment.\n* Subjects with known allergies or intolerances to low-methionine foods.\n* Subjects with any medical or surgical conditions that, in the opinion of the investigator, would make adherence to the methionine-reduced diet unsafe or impractical.",{"count":7,"type":21},[249],"EARLY_PHASE1","This is a pilot clinical trial determining the effect of a Methionine-reduced diet on serum levels in subjects with solid tumors. These are subjects who will receive systemic standard of care cancer therapy.",[252,253,254,255,256,257,258,259,260,261,262,263,264,265,266],"Adenocarcinoma","Basal Cell Carcinoma","Squamous Cell Carcinoma","Transitional Cell Carcinoma","Ductal Carcinoma","Osteosarcoma","Soft Tissue Sarcoma","Ewing Sarcoma","Rhabdomyosarcoma","Leiomyosarcoma","Melanoma","Germ Cell Tumor","Lymphoma","Endocrine Tumor","Glioma","2026-06-02",{"date":214,"type":38},{"date":270,"type":38},"2026-05-01",{"date":272,"type":21},"2028-05-01",{"name":44,"class":45},{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":287,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":4},"100589308","chatbot-for-online-support-groups-to-treat-tobacco-addiction-100589308","NCT06952725","Chatbot for Online Support Groups to Treat Tobacco Addiction","Intelligent Chatbot for Online Support Groups to Treat Tobacco Addiction","Inclusion Criteria:\n\n* Cigarette smokers (can also use e-cigarettes)\n* Ages 18-75 years\n* English speaking\n* Smart phone with unlimited data\n* 100 cigarettes lifetime\n* Prepared to quit smoking within 10 days of study start\n* Active text and email\n* Use of social media or group messaging\n* Home address provided\n* Contact information for a collateral provided\n* Setup of a GroupMe account for study\n\nExclusion Criteria:\n\n* No NRT health contraindications\n* 5+ cigarettes per day\n* Not an illicit drug user\n* Not a daily marijuana\u002Fcannabis user",{"count":204,"type":21},[89],"Investigators will conduct a pilot RCT to test the efficacy of an intelligent chatbot to aid small, private, quit-smoking peer support groups. Participants will be randomized to an intervention arm (chatbot-enhanced support group), or a control arm (support group only). In the intervention arm (N=60), each support group will be connected to an intelligent chatbot running on a secure local server as a trained LLM (large language model). The intelligent chatbot will function as an additional member of the GroupMe support group, but a member that only responds if no human does so. In the control arm (N=60), the support groups will be connected to an automated message-posting bot running on a secure local server. This automated message-posting bot will lack the response capabilities of the intelligent chatbot. But both the intelligent chatbot and the automated message-posting bot will post a pre-written daily discussion topic to encourage participants to discuss issues known to facilitate tobacco cessation or group bonding.",[285,286],"Tobacco Dependence","Tobacco Use Disorder",[288,289,290],"tobacco use addiction","online support group","chatbot","2026-05-20",{"date":293,"type":38},"2026-05-22",{"date":295,"type":21},"2026-12-01",{"date":297,"type":21},"2028-06-01",{"name":44,"class":45},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":307,"maxAge":202,"enrollmentInfo":308,"targetDuration":4,"studyType":310,"phases":4,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":46},"100610360","mapping-ibogaine-neural-dynamics-in-opioid-use-disorder-100610360","NCT07226570","Mapping Ibogaine Neural Dynamics in Opioid Use Disorder","Central Neural Actions of Ibogaine in Opioid Use Disorder (OUD)","MIND-OUD","Inclusion Criteria:\n\n* Adults aged 21-70 with confirmed moderate to severe OUD as assessed by equal or greater than 4 symptoms using DSM-5 criteria.\n* Independently scheduled to receive ibogaine treatment at Ambio Life Sciences in Tijuana, Mexico.\n* Able to undergo MRI and EEG procedures at UC Irvine at Visit 1 (baseline), Visit 4, and Visit 5, totaling three sessions.\n* Able to complete psychometric surveys at each study time point.\n* Able to provide urine samples at all three scanning sessions at UCI.\n* Able to provide urine samples at a local external lab for 3- and 6-month follow-ups.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in English.\n\nExclusion Criteria:\n\n* Presence of known past procedures, devices in the body, claustrophobia, or other contraindications for MRI.\n* Use of any psychedelic substances within 3 months prior to screening.\n* Diagnosis of schizophrenia, bipolar disorder (type I or II), or borderline personality disorder.\n* Use of ibogaine within 6 months prior to screening.\n* Pregnant or nursing. Participants who become pregnant during the study will be withdrawn from further participation.\n* Diagnosis of epilepsy or history of seizures.\n* Other contraindications to MRI\u002FEEG methods. These may include but are not limited to: brain surgical clips and surgical staples, metal implants in the brain, and certain metallic dental material.\n* Inability to complete MRI\u002FEEG sessions or follow-up visits.\n* Inability or unwillingness of an individual to give written informed consent.\n\nNote: UCI does not sponsor or financially support the ibogaine treatment in any way; all treatment costs are the sole responsibility of the participant.","21 Years",{"count":309,"type":21},20,"OBSERVATIONAL","This study aims to understand how ibogaine treatment may change brain activity and symptoms in people with moderate-severe opioid use disorder (OUD), as defined by the DSM-5. Ibogaine is a plant-derived compound that some studies suggest can reduce opioid cravings and withdrawal. Participants in this study will already be independently scheduled to receive legal ibogaine treatment at a licensed clinic outside of the U.S. The University of California, Irvine (UCI) research team will not provide the treatment but will conduct brain imaging, administer psychometric questionnaires, and obtain urine samples throughout the course of this study. UCI does not sponsor or financially support the ibogaine treatment in any way; all treatment costs are the sole responsibility of the participant.\n\nThe main goal is to see if ibogaine changes brain function as assessed with magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), and electroencephalography (EEG). MRI\u002FMRS will measure brain activity when participants view opioid-related images, brain connectivity at rest, and levels of brain chemicals involved in craving and substance use. EEG will measure brain wave activity. MRI\u002FMRS\u002FEEG will be administered across 3 study time points. In addition, participants will complete psychometric surveys related to opioid craving, withdrawal symptoms, mood, anxiety, pain, and quality of life, along with urine tests to monitor substance use and screen for pregnancy.\n\nThe investigators hypothesize that after ibogaine treatment, participants will show reduced brain responses to opioid cues, changes in brain connectivity and chemistry, and improvements in self-reported cravings and other symptoms. This information may help researchers better understand how ibogaine works in the brain and whether it could play a role in future treatments for OUD.",[313],"Opioid Use Disorder (OUD)","2026-05-15",{"date":316,"type":38},"2026-05-18",{"date":318,"type":38},"2025-09-08",{"date":320,"type":21},"2027-05",{"name":44,"class":45},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":22,"phases":330,"briefSummary":331,"conditions":332,"keywords":338,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100640163","biofield-therapy-for-the-support-of-immunotherapy-related-symptoms-among-adult-cancer-patients---a-pilot-study-100640163","NCT07581080","Biofield Therapy for the Support of Immunotherapy-related Symptoms Among Adult Cancer Patients - A Pilot Study","Inclusion Criteria:\n\n* Participants must be greater than 18 years of age.\n* Currently diagnosed with cancer.\n* Actively receiving immunotherapy treatment with ICI (PD1 or -PD-L1 inhibitor (single-agent immunotherapy or immunotherapy in combination with other agents; also including the use of steroids if applicable)\n* Report clinically significant fatigue over the past 7 days.\n* Able to travel to the study site to receive Reiki treatments once a week.\n* Understanding and willing to complete all study procedures.\n* Capable of giving written informed consent.\n* Proficient ability to speak, read, and write in English or Spanish.\n\nExclusion Criteria:\n\n* Individuals currently receiving or received Reiki treatment in the past 30 days\n* Currently diagnosed with a severe psychiatric illness (i.e. schizophrenia, dementia, major depression with suicidal ideations)\n* Currently pregnant or intending to become pregnant during the study timeframe",{"count":329,"type":21},12,[89],"Cancer treatment with immunotherapy is often associated with symptoms such as fatigue, pain, and emotional distress, which may affect patients' daily functioning and quality of life. Additional supportive care approaches are being studied to better understand their potential role in supporting these symptoms.\n\nThe purpose of this study is to learn whether a biofield therapy, called Reiki may help to support adults with cancer who are receiving immunotherapy and currently struggling with fatigue. Reiki is a non-invasive complementary therapy delivered by a trained practitioner who places their hands lightly near the body. It is intended to promote relaxation and support general well-being. Reiki is used as a supportive practice and is not considered a medical treatment or replacement for standard care.\n\nThe secondary goal of this study is to evaluate the feasibility of delivering Reiki in this clinical setting. This includes examining recruitment, retention, adherence to study procedures, and overall participant engagement.\n\nLastly, the third aim is to explore participants' experiences with Reiki through guided interviews.\n\nParticipants enrolled in this study will first be asked to participate in a one-hour, one-on-one interview about their experiences with cancer treatment, their symptoms, and their thoughts about integrative care practices such as Reiki. After the interview, they will be randomly assigned to one of two groups:\n\nImmediate Reiki Group:\n\nIf participants are assigned to this group, they will receive six weekly, in-person 30-minute Usui Reiki sessions from a Reiki master at the Susan Samueli Integrative Health Institute. Before and after each session, participants will complete questionnaires about fatigue, pain, and stress. At the first and final sessions, a small blood sample will be collected to measure inflammatory biomarkers, and Electroencephalogram (EEG) hyperscanning will be conducted to measure brain activity and connectivity between the participant and the practitioner. Four weeks after the final session, they will complete the questionnaires again, followed by a short satisfaction survey about their experience.\n\nWaitlist Group:\n\nIf they are assigned to the waitlist group, they will first complete a 6-week observation period that includes brief weekly fatigue questionnaires and two in-person 30-minute sessions with EEG measurements at Week 1 and Week 6. This will be followed by a 4-week period with no sessions, after which they will complete questionnaires about fatigue, pain, and psychological distress. Participants will then begin the same six weekly, in-person 30-minute sessions described above. As with the Immediate Group, they will complete questionnaires before and after each session. At the first and final sessions, a small blood sample will be collected and EEG hyperscanning will be conducted. At the end of the study, participants will also complete a short satisfaction survey about their experience.\n\nThe investigators hypothesize that participants receiving Reiki will report improvements in symptoms and well-being compared to those not yet receiving Reiki, and that the intervention will be feasible to implement and acceptable to participants.",[333,334,335,336,337],"Cancer","Immunotherapy","Fatigue Related to Cancer Treatment","Pain","Stress",[339,334,333,340,341,342],"Reiki","fatigue","pain","biofield therapy","2026-05-06",{"date":345,"type":38},"2026-05-12",{"date":347,"type":21},"2026-04-20",{"date":349,"type":21},"2027-01",{"name":44,"class":45},2,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":22,"phases":361,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":46},"100433123","phase-1-study-of-ctdna-guided-change-in-tx-for-refractory-minimal-residual-disease-in-colon-adenocarcinomas-100433123","NCT04920032","Study of ctDNA Guided Change in Tx for Refractory Minimal Residual Disease in Colon Adenocarcinomas","Proof of Concept Study of ctDNA Guided Change in Treatment for Refractory Minimal Residual Disease in Colon Adenocarcinomas","Inclusion Criteria:\n\n1. Patients must have histologically or cytologically confirmed adenocarcinoma of the colon (high rectal cancer is eligible if resected and no radiation needed). Other histologies which are treated per NCCN guidelines for adjuvant colon cancer are eligible.\n2. Must have Stage II, Stage III, or Stage IV colorectal cancer after curative intent resection eligible for adjuvant doublet chemotherapy for at least 3 months.\n3. Must have ctDNA positive assay (tested by Signatera MRD assay) after at least 3 months of perioperative chemotherapy\n4. Age ≥ 18 years\n5. Performance status: ECOG performance status ≤2\n6. Life expectancy of greater than 3 months\n7. Adequate organ and marrow function as defined below:\n\n   1. leukocytesL ≥ 3,000\u002FmcL\n   2. absolute neutrophil count: ≥ 1,500\u002FmcL\n   3. platelets: ≥ 80,000\u002Fmcl\n   4. total bilirubin: within normal institutional limits\n   5. AST(SGOT)\u002FALT(SPGT): ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present\n   6. creatinine: \\\u003C1.5 X ULN\n8. The effects of TAS-102 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because topoisomerase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days 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   a. 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).\n9. Ability to swallow tablets\n10. Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Patients who have had major surgery within 4 weeks, or chemotherapy or radiotherapy within 2 weeks prior to Cycle 1 Day 1\n2. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline\n3. Patients may not be receiving any other investigational agents.\n4. Patients with known metastases.\n5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAS-102, irinotecan or other agents used in study.\n6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Prior treatment with TAS-102 at any time or irinotecan within 90 days from enrollment.\n8. History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ.\n9. Inability to comply with study and follow-up procedures as judged by the Investigator\n10. Patients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. -",{"count":360,"type":21},22,[362],"PHASE1","This is a phase 1b, prospective, single arm, non-randomized, open-label clinical trial determining the efficacy of adjuvant trifluridine and tipiracil (TAS-102) in combination with irinotecan in patients with ctDNA positive colon adenocarcinoma.",[365,366],"Colon Adenocarcinoma","Colorectal Cancer",{"date":368,"type":38},"2026-05-11",{"date":370,"type":38},"2021-08-26",{"date":372,"type":21},"2028-01-21",{"name":44,"class":45},{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":181,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":388,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":401,"leadSponsor":403,"locationsCount":46},"100608785","telemedicine-to-support-living-kidney-donor-candidates-100608785","NCT07206069","Telemedicine to Support Living Kidney Donor Candidates","Telemedicine for Evaluation and Counseling of Living Kidney Donor Candidates","Inclusion Criteria:\n\n* 18 years of age or older\n* Reside in the State of California\n* Registered living kidney donor candidate at UC Irvine Medical Center\n\nExclusion Criteria:\n\n\\- Individuals with a contraindication to living kidney donation (for example, heart disease, cancer)",{"count":382,"type":21},70,[89],"The goal of this feasibility clinical trial is to learn if telemedicine can be used to provide education and evaluation and counseling for people who are considering living kidney donation. The study will also learn how participants improve decision-making about living kidney donation. The main questions to answer are:\n\n* Is telemedicine a practical way to facilitate donor education and evaluation and counseling?\n* Does telemedicine shared decision making help improve donor candidate decision and engagement during the donor evaluation process?\n\nResearchers will compare standard care with a telemedicine care coordination approach.\n\nParticipants will:\n\n\\- Receive either standard care or telemedicine video visits to support shared decision making.",[386,387],"Healthy","Living Kidney Donation",[389,390,391,392,393,394,395,396],"Kidney donation","Telemedicine","Education","Counseling","Decision Making, Shared","Feasibility studies","Health Services Research","Care Delivery","2026-05-04",{"date":399,"type":38},"2026-05-05",{"date":397,"type":38},{"date":402,"type":21},"2026-12-30",{"name":44,"class":45},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":410,"eligibilityCriteria":411,"healthyVolunteers":181,"sex":17,"minAge":412,"maxAge":413,"enrollmentInfo":414,"targetDuration":4,"studyType":22,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":46},"100537077","positive-affect-treatment-for-adolescents-with-early-life-adversity-100537077","NCT06273137","Positive Affect Treatment for Adolescents With Early Life Adversity","Mitigating Depression Among Adversity Exposed Adolescents Using Positive Affect Therapy","PAT4ELA","Inclusion Criteria:\n\n* aged 12-16\n* exposed to 2 or more adverse childhood experiences (ACEs)\n\nExclusion Criteria:\n\n* currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies)\n* current or past history of manic or psychotic symptoms\n* parent-reported diagnosis of intellectual disability or autism spectrum disorder\n* chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis),\n* bleeding disorders such as hemophilia","12 Years","16 Years",{"count":415,"type":21},300,[89],"Youth exposed to early life adversity (ELA) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. Youth exposed to ELA consistently report symptoms of anhedonia as well as dysregulated positive affect. The present project will test the efficacy of PAT in a sample of ELA-exposed adolescents in order to determine whether PAT increases positive affect, and subsequently symptoms of depression. For the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or a waitlist control condition. For the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (ACEs) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in PAT or supportive psychotherapy. For both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). The results of this study will be used to inform whether PAT has the potential to prevent major depressive episodes among adversity-exposed youth.",[419],"Depression","2026-04-29",{"date":343,"type":38},{"date":423,"type":38},"2024-02-03",{"date":425,"type":21},"2030-10-31",{"name":44,"class":45},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":431,"acronym":4,"eligibilityCriteria":432,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":433,"targetDuration":435,"studyType":310,"phases":4,"briefSummary":436,"conditions":437,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":46},"100485420","de-escalated-radiation-for-human-papillomavirus-positive-squamous-cell-carcinoma-of-the-oropharynx-100485420","NCT05600842","De-escalated Radiation for Human Papillomavirus-Positive Squamous Cell Carcinoma of the Oropharynx","Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven (from primary lesion and\u002For lymph nodes) diagnosis of human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. HPV-positivity will be defined as tumors that are p16-positive by immunohistochemistry. Numerous studies have demonstrated near 100% agreement between p16 and HPV for patients with oropharyngeal cancer. As such, the use of p16 has been accepted as an appropriate surrogate for HPV status.\n* Clinical stage I, II, or III disease (AJCC Eighth Edition); Note: Patients with M1 tumors (distant metastases) are not eligible;\n* History\u002Fphysical examination within 6 weeks prior to registration, including assessment of weight and recent weight loss;\n* Age ≥ 18;\n* PET\u002FCT within 6 weeks prior to registration;\n* Patients must sign a study-specific informed consent form prior to study entry.\n* Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.\n\nExclusion Criteria:\n\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years;\n* Patients who have had initial surgical treatment other than the diagnostic biopsy of the primary site or nodal sampling of the neck disease are excluded;\n* Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable;\n* Receipt of prior radiotherapy that would result in overlap with proposed field.",{"count":434,"type":21},111,"2 Years","This is a single-arm, observational registry study determining the effects of reduced radiation dose in select patients with human papillomavirus (HPV) positive oropharyngeal cancer.",[438],"HPV Positive Oropharyngeal Squamous Cell Carcinoma",{"date":399,"type":38},{"date":441,"type":38},"2022-11-03",{"date":443,"type":21},"2026-11",{"name":44,"class":45},{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":451,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":46},"100636674","phase-2-utilization-of-flotufolastat-18f-pet-for-post-focal-therapy-prostate-cancer-evaluation-100636674","NCT07568756","Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation","Inclusion Criteria:\n\n* Age 18 years or greater at time of consent\n* Prostate adenocarcinoma (no other histologic subtypes allowed)\n* Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife)\n* Multiparametric-MRI imaging planned\n* Planned pre- and post- treatment MRI-fusion biopsy\n\nExclusion Criteria:\n\n* Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy)\n* Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease\n* PSA \\>10\n* High-risk prostate cancer (diagnosed by biopsy)\n* Bilateral prostatic lobe disease","MALE",{"count":453,"type":21},60,[24],"This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.",[457,458],"Prostate Adenocarcinoma","Prostate Cancer","2026-04-28",{"date":343,"type":38},{"date":462,"type":21},"2026-05",{"date":464,"type":21},"2029-05",{"name":44,"class":45},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":22,"phases":475,"briefSummary":476,"conditions":477,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":46},"100635228","phase-1-phibrandomgemcitabinegwor-wout-pitavastatinpmaintx-unresecpancreaticadenocarcinomaupdac-100635228","NCT07549958","PhIbRandomGemcitabine(G)w\u002For w\u002FOut Pitavastatin(P)MainTx UnresecPancreaticAdenocarcinoma(uPDAC)","Phase Ib Randomized Study of Gemcitabine (G) With Nab-paclitaxel With or Without Pitavastatin (P) in the Maintenance Treatment of Unresectable Pancreatic Adenocarcinoma (uPDAC)","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Provision of a signed and dated ICF by the participant\n* Has a diagnosis of histologically or cytologically confirmed metastatic, recurrent, or locally advanced PDAC\n* Receiving a gemcitabine-based treatment regimen for a minimum of 2 and a maximum of 4 cycles without radiographic progression (ie SD or better).\n* Measurable disease per RECIST 1.1\n* Adequate organ (hematologic, hepatic, renal) function defined below:\n* Hemoglobin ≥ 9.0 g\u002FdL (transfusion is allowed)\n* Platelets ≥ 100,000\u002FmcL (transfusion is allowed)\n* ANC ≥ 1500\u002FmcL\n* AST\u002FALT ≤ 3 x ULN (≤ 5 x ULN is allowable in cases of liver metastasis or Gilbert's Syndrome)\n* Serum bilirubin ≤ 1.5 x ULN\n* Serum albumin ≥ 3.0 g\u002FdL\n* Serum creatinine ≤ 1.5 x ULN OR creatinine clearance \\> 60 mL\u002Fmin\n* ECOG PS 0-2\n* 2 lines or less of prior treatment. Prior curative intent treatment (surgery and, if given in the adjuvant setting, systemic therapy and\u002For radiation) is permitted, regardless of time to recurrence, and does not constitute a line of therapy. This includes participants with residual disease after surgery, who received systemic therapy, chemoembolization, or radiotherapy.\n\nExclusion Criteria:\n\n* Uncontrolled significant clinical illness\n* Clinically significant autoimmune disease\n* Major surgery within 4 weeks of the first dose of registration\n* Known prior malignancy active within the previous 3 years, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Concomitant use of statin therapy (to be discontinued 2 weeks prior to the start of C1D1).\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HbsAg) are eligible.\n* Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Patients with a known history of HIV.\n* Known active metastases in the central nervous system (unless stable by brain imaging studies for at least 1 month after last treatment)\n* Patients with QT interval corrected by Fridericia's formula (QTcF) \\> 470 msec for both men and women on screening ECG are excluded.\n* A woman of childbearing potential who has a positive pregnancy test prior to initiating study treatment.\n* Breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 5 months after the last dose of study treatment.\n* Medicines known to inhibit or induce either CYP2C8, CYP2C9, or CYP3A4\n* History of prior organ or stem cell transplant.\n* Has an active infection requiring systemic therapy. Systemic treatment used prophylactically is allowable.\n* Patients who are unable to swallow or retain oral medication.",{"count":474,"type":21},18,[362],"This is a phase 1, open-label clinical trial determining the recommended Phase 2 dose of Gemcitabine with Nab-paclitazel with or without Pitavastatin in subjects with unresectable pancreatic adenocarcinoma (uPDAC). These are subjects who are already receiving Gemcitabine for treatment of their disease.",[478,479],"Pancreatic Cancer","Pancreatic Cancer Metastatic",{"date":397,"type":38},{"date":482,"type":38},"2026-03-24",{"date":484,"type":21},"2028-03-31",{"name":44,"class":45},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":22,"phases":494,"briefSummary":495,"conditions":496,"keywords":499,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":502,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":46},"100614606","phase-1-treating-anemia-in-myelofibrosis-with-repurposed-drugs-nelfinavir-that-restore-iron-delivery-to-the-bone-marrow-100614606","NCT07281781","Treating Anemia in Myelofibrosis With Repurposed Drugs (Nelfinavir) That Restore Iron Delivery to the Bone Marrow","Inclusion Criteria:\n\n* ≥18 years of age\n* Have a diagnosis of myelofibrosis (MF) according to the 2016 WHO criteria\n* Has a hemoglobin ≤ 10gm\u002FdL at screening\n* Serum ferritin ≥ 100\n* May continue on current MPN treatment, including aspirin, hydroxyurea, interferon-alpha, ruxolitinib, fedratinib, or anagrelide.\n* Peripheral blast count \\\u003C10% during Screening.\n* Free of other known active or metastatic malignancies other than localized skin cancer.\n* Amenable to blood draws and symptom assessments.\n* Agree to the use of contraceptives. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, should both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.\n\nExclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) questionnaire score of ≥3\n* Currently pregnant or planning on being pregnant within the study period.\n* Currently taking Momelotinib or Pacritinib (these agents are purported to reduce hepcidin).\n* Currently taking any of the contraindicated medications to Nelfinavir listed in section 13.2\n* Currently breastfeeding.\n* Known uncontrolled active viral or bacterial infection.\n* Known HIV+\n* Significant impairment of major organ or hematopoietic function defined as\n\n  1. Serum creatinine clearance less than 30 ml\u002Fmin (eGFR).\n  2. Bilirubin more than 1.5 mg\u002Fdl except for Gilbert's disease. ALT or AST more than 2X upper normal limit or has radiologic evidence of liver cirrhosis.\n  3. Platelets \\\u003C 50 × 10\\^9\u002FL without transfusions\n  4. ANC \\\u003C 0.75 × 10\\^9\u002FL without growth factors\n* Known history of allergic reaction to nelfinavir.",{"count":493,"type":21},10,[362,24],"This is a phase I\u002FII protocol investigating whether Nelfinavir can improve anemia and lower serum fibrosis biomarkers in Myelofibrosis patients.",[497,498],"Myelofibrosis","Myelofibrosis; Anemia",[497,500,501],"Anemia","Nelfinavir",{"date":397,"type":38},{"date":504,"type":38},"2025-09-16",{"date":506,"type":21},"2027-06",{"name":44,"class":45},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":22,"phases":517,"briefSummary":518,"conditions":519,"keywords":522,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":533,"locationsCount":46},"100568553","phase-2-adjuvant-sacituzumab-govitecan-and-nivolumab-in-muscle-invasive-urothelial-carcinoma-at-high-risk-recurrence-100568553","NCT06682728","Adjuvant Sacituzumab Govitecan and Nivolumab in Muscle-Invasive Urothelial Carcinoma at High-Risk Recurrence","Adjuvant Sacituzumab Govitecan Plus Nivolumab in Patients With Muscle-Invasive Urothelial Carcinoma at High-Risk for Recurrence","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of study consent.\n* ECOG Performance Status of 0, 1 or 2 (see Appendix A).\n* Histologically confirmed muscle-invasive UC originating in the bladder, ureter, or renal pelvis. Variant histology, except small cell carcinoma, is allowed.\n* Underwent curative-intent surgery (i.e. RC or nephroureterectomy), performed within 180 days prior to study treatment initiation.\n* Radiographic disease-free status as determined by imaging within 28 days of C1D1 of study treatment.\n* Prior platinum-based NAC is allowed. If chemotherapy-naive, patient must be Cisplatin-ineligible (based on Galsky et al 2011 \\[10\\]) or refuse platinum AC.\n* Prior treatment with neoadjuvant investigational agents is allowed (except PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan). No washout from neoadjuvant therapy is required.\n* If NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T2, T3, T4, or N+ disease on RC or nephroureterectomy surgical spec-imen.\n* If no NAC was given, patient must be considered at high risk for cancer recurrence due to having pathologic T3, T4, or N+ disease on RC or nephroureterectomy surgical speci-men.\n* Adequate organ and marrow function as defined below:\n* ANC ≥ 1000\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Total bilirubin ≤ 1.5 × institutional ULN (or ≤ 3.0 × ULN for subjects with Gilbert's disease)\n* AST\u002FALT ≤ 3 × institutional ULN\n* Alkaline phosphatase ≤ 3 × institutional ULN\n* Serum albumin ≥ 2.8 g\u002FdL\n* Creatinine Creatinine clearance of ≥30 mL\u002Fmin (calculated with Cockroft-Gault formula)\n* Hemoglobin ≥ 9.0 g\u002FdL\n* aPTT ≤ 1.5 × institutional ULN\n* Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (i.e. barrier methods including male condom, female condom, or diaphragm with spermicidal gel, etc.) that are approved by the Investigator. Contra-ception must be used during the course of the treatment and for 6 months after the last dose of study treatment.\n* Female subjects of childbearing potential must not be pregnant following signing the study consent form. Female subjects are considered to be of childbearing potential unless one of the following criteria are met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal sta-tus (defined as at least 12 months of amenorrhea in a woman ≥ 45 years-of-age in the ab-sence of other biological or physiological causes).\n* Recovery to ≤ Grade 1 of CTCAE version 5 toxicities related to any prior treatment for UC, unless the AE(s) is clinically non-significant and\u002For stable on supportive therapy as per discretion of the Investigator.\n* Subjects with any type of genitourinary catheters (i.e. nephrostomy, Foley, etc) are al-lowed.\n* Ability to understand and the willingness to sign a written informed consent. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, hard of hearing, and illiterate individuals are eligible for this trial.\n\nExclusion Criteria\n\n* Underwent a partial cystectomy or partial nephrectomy.\n* History of adjuvant platinum-based chemotherapy or any other type of adjuvant therapy, including investigational agents, following surgical removal of UC.\n* History of treatment with PD-1\u002FPD-L1 inhibitors or sacituzumab govitecan prior to study treatment initiation.\n* History of previous radiation therapy for treatment of UC.\n* Radiographic evidence of metastasis.\n* Receipt of or planning to receive any other concurrent investigational agents.\n* History of active, known, or suspected autoimmune disease.\n* Conditions requiring treatment with either systemic high-dose corticosteroids (e.g. prednisone dose of ≥ 10 mg or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.\n* Inhaled or topical steroids are permitted in the absence of active autoimmune dis-ease.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.\n* Major surgery within 28 days or minor surgery within 14 days before the first dose of study treatment. Subjects must have complete wound healing and resolution from complications of major or minor surgery before first dose of study treatment.\n* Active malignancy within 3 years of study entry, except treated localized non-melanoma skin cancer, Gleason 6 prostate cancer on active surveillance, or curatively treated in situ cancer of the breast or cervix.\n* Patients who do not have adequate organ and marrow function, as defined in Section 4.1 above.\n* Uncontrolled intercurrent illness including, but not limited to, the following conditions:\n* Active and\u002For uncontrolled bacterial, viral, or fungal infection within 7 days of study treatment initiation.\n* History of HIV infection with detectable viral load.\n* History of Hepatitis B or C infection with detectable viral load.\n* History of severe liver impairment (Child-Pugh C liver cirrhosis).\n* History of active tuberculosis (Bacillus tuberculosis).\n* Congestive heart failure New York Heart Association (NYHA) Class 3 or 4, unstable angina pectoris, or serious uncontrolled cardiac arrhythmias.\n* Stroke (including transient ischemic attack (TIA), myocardial infarction (MI), or other ischemic arterial event within 90 days before first dose of study treatment.\n* Severe, uncontrolled bleeding within 14 days before first dose of study treatment.\n* Uncontrolled diarrheal illness ≥ Grade 3 in severity within 14 days before first dose of study treatment.\n* History of inflammatory bowel disease (i.e. ulcerative colitis, Crohn's disease, etc.) or any other condition that puts patients at high risk of developing severe diarrhea.\n* Psychiatric illness\u002Fsocial situations causing inability to comply with study proce-dures or follow up.\n* Pregnancy at the time of or following study consent.\n* Breastfeeding at the time of or following study consent.\n* Received a live vaccine within 28 days prior to the first dose of study treatment.\n* Known or suspected severe hypersensitivity (Grade ≥ 3) to nivolumab, sacituzumab govitecan, irinotecan, and\u002For any of their components.\n* History or current evidence of any condition, therapy, or laboratory\u002Fradiographic abnormal-ity that might confound the results of the study, interfere with the patient's ability to participate for the full duration of the study, or is not in the best interest of the patient to partici-pate in the study, in the opinion of the Investigator.",{"count":516,"type":21},23,[24],"This is a phase 2 study, single-arm study of adjuvant combination therapy with Sacituzumab Govitecan and Nivolumab in patients with muscle-invasive urothelial carcinoma of the bladder, ureter, or upper tract, who are high risk for cancer recurrence post curative-intent surgery based on surgical pathology.",[520,521],"Urothelial Carcinoma","Muscle-invasive Bladder Cancer",[523,520,524,525,526,527],"UC","muscle-invasive urothelial carcinoma","MIBC","sacituzumab govitecan","nivolumab",{"date":529,"type":38},"2026-04-30",{"date":531,"type":38},"2024-11-15",{"date":295,"type":21},{"name":44,"class":45},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":541,"targetDuration":4,"studyType":22,"phases":543,"briefSummary":544,"conditions":545,"keywords":548,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":552,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":46},"100541884","mpmri-compared-to-diagnostic-turbt-in-patients-with-suspected-muscle-invasive-bladder-cancer-100541884","NCT06335667","mpMRI Compared to Diagnostic TURBT in Patients With Suspected Muscle-Invasive Bladder Cancer","Outcomes With Multi Parametric MRI (mpMRI) Compared to Diagnostic Transurethral Resection of Bladder Tumor (TURBT) in Patients With Suspected Muscle-Invasive Bladder Cancer - a Pilot Study","Inclusion Criteria:\n\n* Age 18 years old or greater at the time of consent.\n* Suspected muscle-invasive bladder cancer by tumor appearance on initial routine cystoscopy as determined by the UCI-affiliated provider performing this procedure.\n* ECOG Performance Status of 0-3.\n* Patients must have the ability to understand and the willingness to sign a written informed consent document (prior to the initiation of the study and any study procedures).\n* Patients must be willing and able to comply with the scheduled visits, imaging plan, follow up plan, and other specified study procedures in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Prior TURBT within 120 days of study entry.\n* Prior therapy for bladder cancer within 180 days of study entry.\n* Inability to tolerate mpMRI or associated contrast.\n* Inability to tolerate TURBT or associated anesthesia.\n* ECOG Performance Status of 4.\n* Female patient who is known to be pregnant or breastfeeding.",{"count":542,"type":21},30,[89],"This is a pilot, single arm, prospective study that aims to validate the accuracy of the VI-RADS score obtained via multi-parametric magnetic resonance imaging (mpMRI) compared to pathologic cancer stage obtained via diagnostic transurethral bladder tumor resection (TURBT) as well as compare the clinical and quality of life outcomes between these diagnostic modalities in patients with suspected muscle-invasive bladder cancer (MIBC).",[546,547],"Urothelial Bladder Cancer","Muscle-Invasive Bladder Cancer",[549,550,551],"mpMRI","TURBT","VI-RADS score",{"date":397,"type":38},{"date":554,"type":38},"2024-03-27",{"date":556,"type":21},"2030-04",{"name":44,"class":45},{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":4,"eligibilityCriteria":564,"healthyVolunteers":12,"sex":83,"minAge":18,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":22,"phases":567,"briefSummary":568,"conditions":569,"keywords":572,"overallStatus":233,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":579,"locationsCount":4},"100402428","phase-1-effect-of-nac-on-preventing-chemo-related-cognitive-impairments-in-ovarian-ca-pts-treated-w-pbt-100402428","NCT04520139","Effect of NAC on Preventing Chemo-Related Cognitive Impairments in Ovarian Ca Pts Treated W\u002F PBT","Phase I Dose-Escalating and Phase II Dose-Expansion Study of N-Acetyl-Cysteine (NAC) Administration to Ovarian Cancer Patients Receiving Platinum-Based Therapy (PBT) for the Mitigation of Chemotherapy-Related Cognitive Impairment (CRCI)","Inclusion Criteria:\n\nPost-menopausal females (as defined by lack of menstruation for 12 months or status post oophorectomy)\n\n* Histologic or pathologic diagnosis of stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer\n* Eastern Cooperative Oncology Group (ECOG) ≤2\n* Life expectancy \\> 1 year\n* Status post cytoreductive surgery for ovarian cancer or with planned cytoreductive surgery if treated with neoadjuvant chemotherapy\n* Prescribed a minimum of six cycles of platinum-based chemotherapy\n* Adequate organ function as defined below:\n\n  1. Hemoglobin \\> 9 g\u002FdL\n  2. Leukocytes \\>1,500\u002Fmcl\n  3. Absolute Neutrophil Count \\> 1,000\u002FmcL\n  4. Platelets \\> 125,00\u002FmcL\n  5. total bilirubin Within normal institutional limits\n  6. Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\\u003C 2.5 x institutional upper limit of normal\n  7. Serum creatinine \\\u003C 1.5 mg\u002FdL.\n\nExclusion Criteria:\n\n* Prior history of any cancer (other than non-melanoma skin cancer)\n* Chemotherapy, radiation therapy, or erythropoietin treatment within the last 6 months\n* Prior severe head injury\n* Has a history of dementia or other neurodegenerative disorders\n* Has an uncontrolled, treatment-resistant depression or other severe psychiatric illnesses\n* Presence of known brain metastases\n* Has an active infection requiring treatment\n* Known immunosuppressive disease\n* Has active systemic autoimmune diseases such as lupus\n* Receipt of systemic immunosuppressive therapy\n* Known human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C\n* Pregnant of breastfeeding.",{"count":566,"type":21},102,[362,24],"This is a phase I, dose-escalation and phase II dose-expansion clinical trial determining the maximum tolerated dose (MTD) and safety and tolerability of adding N-Acetyl-Cysteine (NAC) to ovarian cancer patients who are receiving a platinum-based therapy (PBT). This study will investigate whether NAC will mitigate chemotherapy-related cognitive impairment (CRCI).",[570,571],"Ovarian Cancer","Cognitive Impairment",[573],"Chemotherapy-Related Cognitive Impairments","2026-04-23",{"date":420,"type":38},{"date":462,"type":21},{"date":578,"type":21},"2027-12",{"name":44,"class":45},{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":181,"sex":17,"minAge":435,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":46},"100517679","latinx-children-and-surgery-100517679","NCT06020677","Latinx Children and Surgery","Inclusion Criteria:\n\nChildren:\n\n1. Children age 2-7 who are scheduled to undergo outpatient surgery.\n2. Children of Latinx parents, who speak Spanish as a primary language and who may speak English\n3. Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to \"patients who are normal and healthy with no known systemic disease\". ASA status II refers to \"patients who have mild or well-controlled systemic diseases,\" such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies. ASA status III refers to patients who have moderate or severe systemic disease, which does limit their activities (e.g., stable angina or diabetes with systemic sequellae). This criteria was chosen as this group of children will typically undergo surgery in an outpatient setting. ASA status IV children will most likely undergo surgery in an inpatient setting and represents a much sicker population of children with different barriers.\n4. Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents at the time of recruitment. The rationale for excluding patients with developmental delay is that it is unknown whether parents manage their children's postoperative pain differently than in the general population. To generalize the findings to the general population, children with developmental delays will be excluded.\n\nExclusion Criteria:\n\n1. Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to \"patients with an incapacitating systemic disease that is a constant threat to life\". ASA status V \"patients are considered moribund\".\n2. Children whose parents do not identify as Latinx will be excluded from this study.\n3. Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study because of the potential for confounding effects on pain.\n4. Children with current malignant or any other disease or pain condition will be excluded as this may impact postoperative pain and thus be a confounding variable.\n\nParent:\n\nInclusion Criteria:\n\n1\\. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary language and who may speak English.\n\nExclusion Criteria:\n\n1. Parents who refuse to be part of the study.\n2. Parents who do not speak Spanish as the primary language.","7 Years",{"count":204,"type":21},[89],"Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16.\n\nSurgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Data from the investigator's center indicates that a substantial portion of Latinx children who undergo surgery experience high anxiety and postoperative pain as well as postoperative impairments in psychological and physical functioning as compared to White non-Latin children who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in surgical outcomes.\n\nIn a previous National Institutes of Health (NIH) award, the principal investigator (PI) developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to prepare and be a companion of a child and their family during a surgical event. WebTIPS aims to enhance the recovery of the child in several ways such as reducing anxiety and pain and is based on information provision, modeling, and teaching of coping skills. WebTIPS, however, was developed and validated with a population of primarily White non-Latinx English-speaking children and their parents. Unfortunately, it is well established that mHealth interventions are significantly less effective when used with specific ethnic minorities unless they underwent a process of cultural adaptation. Over the past 4-years, the investigators have established multiple academic and community collaborations, conducted extensive participatory research with Latinx stakeholders and used the heuristic framework and a modified ecological validity model to culturally adapt WebTIPS. The culturally adapted intervention is called L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a population of Latinx children undergoing surgery. The first phase of this application (R61) includes web programming of L-WebTIPS, and a feasibly randomized control trial (RCT) to test this intervention. The second phase (R33) includes a multi-center RCT which aims to determine the effectiveness of L-WebTIPS compared to attention control intervention in decreasing postoperative pain, opioids consumption and lowering anxiety in Latinx children undergoing outpatient surgery. Secondary aims of the R33 include examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain, analgesic requirements, new onset behavioral changes and return to normal daily activity in Latinx children undergoing outpatient surgery. The investigators also plan to determine if the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx children undergoing surgery.\n\nFinally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and enhance experience among the parents of Latinx children undergoing surgery. The investigators submit that using a cultural adaption process for an existing validated intervention will accelerate the process of reducing surgical disparities and bringing an effective intervention to clinical settings and routine use.",[591,592],"Pain, Postoperative","Pain, Acute","2026-04-09",{"date":595,"type":38},"2026-04-14",{"date":597,"type":38},"2023-08-23",{"date":599,"type":21},"2027-08-31",{"name":44,"class":45},{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":618,"lastUpdatePostDateStruct":619,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":351},"100576319","mechanistic-and-clinical-outcomes-of-a-surgical-innovation-aimed-at-minimizing-gerd-associated-with-vsg-innovate-vsg-100576319","NCT06783751","Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With VSG (INNOVATE-VSG)","Mechanistic and Clinical Outcomes of a Surgical Innovation Aimed at Minimizing GERD Associated With Vertical Sleeve Gastrectomy (INNOVATE-VSG)","INNOVATE-VSG","Inclusion Criteria:\n\n1. Male and female subjects aged 18-65 years\n2. Body mass index (BMI) 35-55 kg\u002Fm2\n3. Must meet the BMI criteria before and after 6 months of nonsurgical weight management\n4. Presence of GERD defined for this trial as acid exposure time (AET) of 4.9% or above as assessed with the Bravo pH test.\n5. Have health insurance which pays for the costs of bariatric surgery and standard medical care before and after surgery\n6. Women of childbearing potential must be using appropriate contraception to avoid pregnancy throughout the study, and must have a negative pregnancy test at study entry and prior to surgery\n7. Must be able to provide written informed consent\n\nExclusion Criteria:\n\n1. Hiatal hernia \\>2cm (defined as maximum axial height from end of the esophagus to diaphragm by any study including upper endoscopy esophagram and or at the time of surgery)\n2. Evidence of clinically significant major esophageal motility disorder as determined by the site primary investigator\n3. Severe gastroparesis\n4. Previous bariatric or anti-reflux procedure\n5. Barrett's esophagus\n6. Subjects requiring mesh treatment at time of procedure\n7. Severe heart (e.g., severe heart failure, unstable coronary artery disease), or end-stage lung disease as determined by the site primary investigator\n8. Subjects with pacemakers, implantable defibrillators, neurostimulators\n9. Portal hypertension or cirrhosis\n10. Chronic pancreatitis\n11. Active cancer treatment\n12. Inability to tolerate general anesthesia\n13. Uncontrollable coagulopathy\n14. Significant and uncontrolled inflammatory bowel disease\n15. Severe and\u002For uncontrolled psychiatric disorder (including psychosis, bipolar disorder) as determined during standard pre-surgery psychiatric screening at the site.\n16. Suicidal ideation or unstable\u002Funtreated major depressive disorder within the past year\n17. Alcohol or substance use disorder within the past year.\n18. Pregnant or breastfeeding or planning pregnancy in the coming 24 months\n19. Diminished intellectual capacity to consent or follow pre- and post-surgery instructions\n20. History of, or any current health condition that, in the opinion of the PI, would make the subject ineligible for sleeve gastrectomy, or put the subject at risk by participation in the study.","65 Years",{"count":611,"type":21},44,[89],"This is a two-site randomized clinical trial aiming to test whether a modified investigational bariatric surgical procedure can improve gastroesophageal reflux disease (GERD) after sleeve gastrectomy.",[208,615,616,617],"Bariatric Surgery","Sleeve Gastrectomy","Gastroesophageal Reflux Disease","2026-04-08",{"date":620,"type":38},"2026-04-13",{"date":622,"type":38},"2025-03-21",{"date":624,"type":21},"2027-07-31",{"name":44,"class":45},""]