[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Yale University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":594},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,290,0,25,[9,42,71,94,119,139,162,182,208,231,253,276,295,317,340,361,386,404,429,467,488,512,530,553,574],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100053301","neural-mechanisms-of-the-social-brain-100053301",false,"NCT07457567","Neural Mechanisms of the Social Brain","Neural and Behavioral Correlates of Live Face-to-Face Interactions","Inclusion Criteria:\n\n-Self reported typically developed adults.\n\nExclusion Criteria:\n\n-No prior history of seizure activity. Self reported absence of recreational drugs at time of study.",true,"ALL","18 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to understand the neural mechanisms that underlie synchronization of two brains during social interactions.",[28],"Live Face Processing in Typically Developed Participants","RECRUITING","2026-07-10",{"date":32,"type":33},"2026-07-13","ACTUAL",{"date":35,"type":33},"2025-11-03",{"date":37,"type":22},"2028-07-31",{"name":39,"class":40},"Yale University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":17,"sex":18,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100053714","early-phase-1-mechanistic-studies-of-psilocybin-in-headache-disorders-100053714","NCT06464367","Mechanistic Studies of Psilocybin in Headache Disorders","Inclusion criteria:\n\n* Age 21 to 70 (inclusive)\n* Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient\n\nExclusion criterion\n\n* Unstable medical condition or serious nervous system pathology\n* Pregnant, breastfeeding, lack of adequate birth control\n* Psychotic or manic disorder\n* Substance abuse in the prior 3 months\n* Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months\n* Use of cannabis or other THC products in the prior 2 weeks\n* Urine toxicology positive to drugs of abuse\n* The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average\n* Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks\n* Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks, chiropractic manipulation)\n* History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).\n* Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.","21 Years","70 Years",{"count":21,"type":22},[52],"EARLY_PHASE1","In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.",[55],"Migraine",[57,58,59,60,61,62,63],"psilocybin","resting state functional connectivity","synaptic density","synaptic vessel glycoprotein 2A (SV2A)","circadian rhythm","sleep","inflammation","2026-07-09",{"date":32,"type":33},{"date":67,"type":33},"2025-05-19",{"date":69,"type":22},"2027-12-31",{"name":39,"class":40},{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100053682","exercise-intervention-and-immunodeficiency-100053682","NCT07698197","Exercise Intervention and Immunodeficiency","Exercise Intervention in Primary Antibody Deficiency Disorders: A 12-week Feasibility Study","Inclusion Criteria:\n\n* Diagnosed with one of the following primary antibody deficiencies: IgG subclass deficiency, selective IgA deficiency, selective IgM deficiency, or specific antibody deficiency\n* Receiving care in the Section of Rheumatology, Allergy \\& Immunology\n* Able and willing to participate in a moderate-intensity exercise program. Patients will be screened using the American College of Sports Medicine (ACSM) Pre- participation Screening Guidelines. This algorithm assesses patients for cardiovascular, renal, and metabolic disease. Those patients determined to not require further medical clearance to participate in exercise will be included.\n\nExclusion Criteria:\n\n* Receipt of immunoglobulin (Ig) replacement therapy\n* Use of immunosuppressive or immunomodulatory medications (e.g., chronic systemic corticosteroids, B-cell-depleting therapies)\n* Medical contraindications to moderate-intensity exercise as determined by clinical assessment using the previously discussed ACSM Pre-participation Screening Guidelines.\n* Other risk factors\u002Fmedical conditions that would limit safe participation in exercise as determined by clinical assessment, including active rheumatologic conditions including active rheumatoid arthritis.","65 Years",{"count":80,"type":22},20,[25],"The purpose of this study is to assess if a 12-week exercise program is safe, practical, and acceptable for adults with primary antibody deficiencies. It also looks at whether the program can improve the quality of life and help the immune system work better.",[84],"Primary Antibody Deficiency Disorders","NOT_YET_RECRUITING","2026-07-06",{"date":32,"type":33},{"date":89,"type":22},"2026-07",{"date":91,"type":22},"2027-07",{"name":39,"class":40},2,{"id":95,"slug":96,"hasResults":12,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":17,"sex":101,"minAge":19,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100513690","leveraging-chatbot-to-improve-prep-in-the-southern-united-states-100513690","NCT05968755","Leveraging Chatbot to Improve PrEP in the Southern United States","Leveraging Chatbot Technology to Improve PrEP Awareness and Uptake Among Black MSM in the Southern United States","Inclusion Criteria:\n\n* Being cisgender Black male\n* Being aged ≥ 18 years\n* Having Internet access\n* Speaking English\n* Self-reporting condomless sex with another man in the past 6 months\n* HIV negative or untested.\n\nExclusion Criteria:\n\n* Having lived in the US South less than 3 months\n* Having received antiretroviral therapy (ART) treatment.","MALE",{"count":103,"type":22},145,[25],"The purpose of this study is to develop a chatbot intervention to promote PrEP awareness and uptake among Black men who have sex with men (MSM) in the Southern United States.",[107,108,109],"HIV Prevention","PrEP Awareness","PrEP Uptake","2026-07-01",{"date":112,"type":33},"2026-07-02",{"date":114,"type":22},"2026-07-20",{"date":116,"type":22},"2027-07-01",{"name":39,"class":40},4,{"id":120,"slug":121,"hasResults":12,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":78,"enrollmentInfo":126,"targetDuration":4,"studyType":23,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":41},"100627030","culturally-adapted-contingency-management-100627030","NCT07443332","Culturally Adapted Contingency Management","Cultural Adaptation of Contingency Management for Black Adults With Stimulant Use Disorder","Inclusion Criteria:\n\n* participants must self-identify as Black\u002FAfrican American\n* DSM-5 diagnosis of stimulant use disorder in the past month (30 days)\n\nExclusion Criteria:\n\n* individuals who are intoxicated or otherwise unable to provide consent",{"count":127,"type":22},70,[25],"The purpose of this study is to develop a culturally adapted contingency management (CM) protocol for Black adults with stimulant use disorder.",[131],"Stimulant Use Disorders","2026-06-30",{"date":110,"type":33},{"date":135,"type":22},"2028-07",{"date":137,"type":22},"2030-03",{"name":39,"class":40},{"id":140,"slug":141,"hasResults":12,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":41},"100600931","aerobic-exercise-and-obsessive-compulsive-disorder-symptoms-100600931","NCT07103902","Aerobic Exercise and Obsessive-Compulsive Disorder Symptoms","Effects of Aerobic Exercise on Obsessive-Compulsive Disorder Symptoms and Cognitive Flexibility","Inclusion Criteria:\n\n* Adults, age 18 to 64 years\n* Meet diagnostic criteria for OCD (per the DIAMOND)\n* Stable psychiatric or medication treatment (if ≥4-weeks), or if no active treatment. Psychotropic medications will be reviewed with the study psychiatrist on a case by case basis.\n\nExclusion Criteria:\n\n* Active or unmanaged psychotic disorders, pervasive developmental disorders, bipolar disorder, current substance use disorder (moderate-to-severe), or high risk for suicide (defined as attempt, plan, or intent within past 3 months)\n* Documented motor impairments and medical condition(s) that prohibit physical exercise\n* Those who are pregnant or trying to become pregnant","64 Years",{"count":21,"type":22},[25],"The purpose of this study is to examine the acute effects of exercise on cognitive flexibility and symptom reactivity. The main questions it aims to answer are:\n\nDoes moderate intensity physical activity reduce subjective distress, compulsive urges, and intrusions- and increase cognitive flexibility- in adults with obsessive-compulsive disorder compared to low-intensity physical activity?\n\nResearchers will compare low- to moderate-intensity exercise to see if moderate physical activity increases cognitive flexibility and reduces symptom reactivity in adults with obsessive-compulsive disorder (OCD).\n\nParticipants will:\n\nComplete self-report surveys, psychiatric interviews, and cognitive tasks.\n\nBe assigned to either a low- or moderate-intensity exercise condition and complete physical activity.\n\nRepeat cognitive and symptom measures following the exercise intervention.",[151],"Obsessive-Compulsive Disorder (OCD)",[153,154,155],"Anxiety Disorders","Mental Disorders","Obsessive-Compulsive Disorder",{"date":112,"type":33},{"date":158,"type":33},"2026-02-16",{"date":160,"type":22},"2026-09-01",{"name":39,"class":40},{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":41},"100587662","effect-of-hbot-on-femoral-head-avascular-necrosis-avn-100587662","NCT06931301","Effect of HBOT on Femoral Head Avascular Necrosis (AVN)","Effect of Hyperbaric Oxygen Therapy on Osteonecrosis of the Femoral Head When Combined With 3D Navigated Core Decompression With Bone Marrow Aspirate Concentrate","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Diagnosed with femoral head avascular necrosis\n* Enrolled into Yale Avascular Necrosis Program\n* Avascular necrosis lesion is classified as ARCO I or ARCO II by Investigator\n* Surgical Candidate for Core Decompression using 3D image guidance with bone marrow aspirate concentrate\n\nExclusion Criteria:\n\n* Hip has already collapsed due to severe avascular necrosis (ARCO III or ARCO IV)\n* Medical comorbidities that prevent them from being a surgical candidate (example: obesity)\n* Absolute contraindications to HBOT, including severe decompensated cardiac failure or lung disease putting them at high risk for pneumothorax\n* Pregnant\n* Prisoner\n* Does not sign Informed Consent Form",{"count":170,"type":22},400,[25],"The primary objective of this study is to determine whether the Hyperbaric Oxygen Therapy (HBOT) conducted under the Marx Protocol improves pain outcomes when combined with core decompression with autologous bone marrow aspirate concentrate to treat patients with femoral head avascular necrosis.",[174,175],"Osteonecrosis","Avascular Necrosis",{"date":110,"type":33},{"date":178,"type":22},"2026-12",{"date":180,"type":22},"2035-04",{"name":39,"class":40},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":23,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":202,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":41},"100570402","the-mechanism-underlying-the-analgesic-effect-of-the-music-of-ibs-pain-100570402","NCT06706778","The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain","Impacts of Music-based Intervention on Pain in Individuals With Irritable Bowel Syndrome (IBS): A Mechanistic Pilot Study","Inclusion Criteria:\n\n* aged between 18 and 50 years old,\n* can speak and read English,\n* having a confirmed diagnosis of IBS from a healthcare provider,\n* having experienced moderate pain (≥3 out of 10 on a numeric rating scale) at least four days a week for the past three months,\n* be willing to participate in a 4-week intervention and attend two lab visits, and\n* having daily access to an internet-enabled device for MBI.\n\nExclusion Criteria:\n\n* having a severe psychiatric disorder requiring inpatient treatment in the past six months,\n* regularly using opioids or illicit substances, or have used probiotics or antibiotics within two weeks prior to enrollment,\n* having celiac disease, inflammatory bowel disease, or a history of major gastrointestinal surgery,\n* concurrently participate in another IBS-related intervention study.","50 Years",{"count":191,"type":22},30,[25],"The proposed pilot study aims to assess the underlying mechanisms of the MBI on IBS pain and the feasibility of using novel technology in the outcome measurements. The specific aims of this pilot mechanistic clinical trial are to:\n\n1. . identify the mechanisms underlying the impact of MBI on IBS-related pain, stress responses, quantitative pain sensitivity, and gut microbiome profiles.\n2. . evaluate the technological feasibility of using a wearable abdominal sensor belt and smartwatch system in measuring MBI impacts on pain in home settings.\n\nResearchers will conduct a one-arm pre- and post-music intervention among patients with Irritable Bowel Syndrome, collect the IBS pain mechanistic biobehavioral markers, and analyze the underlying pathways of the music analgesic effect.\n\nParticipants will be asked to:\n\n1. . engage in a 4-week intervention of 20 minutes, both during the day and at night, for at least five days per week.\n2. . have two one-hour lab visits",[195,196],"Abdominal Pain\u002F Discomfort","Irritable Bowel Syndrome",[198,199,200,201,196],"abdominal pain","Music","Brain-gut axis","Stress",{"date":112,"type":33},{"date":204,"type":22},"2026-08",{"date":206,"type":22},"2027-03",{"name":39,"class":40},{"id":209,"slug":210,"hasResults":12,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":4,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":23,"phases":217,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":41},"100523822","phase-2-sipuleucel-t-combined-with-bipolar-androgen-therapy-in-men-with-mcrpc-100523822","NCT06100705","Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC","A Single Arm Open-label, Phase II Study of Sipuleucel-T With Bipolar Androgen Therapy in Men With Metastatic Castration-resistant Prostate Cancer","Inclusion Criteria:\n\n* Written informed consent obtained prior to the initiation of study procedures.\n* Patients who meet the US FDA-approved indication for Sipuleucel-T: for asymptomatic or minimally symptomatic mCRPC at the discretion of the treating investigator.\n* Histologically confirmed adenocarcinoma of the prostate.\n* Metastatic disease as evidenced by soft tissue and\u002For bony metastases on baseline bone scan and\u002For computed tomography (CT) scan or Magnetic Resonance Image (MRI).\n* Progressive castration-resistant prostate cancer (CRCP): Participants must have current or historical evidence of disease progression concomitant with surgical or medical castration and during immediate past systemic therapy, as demonstrated by (a) PSA progression, or (b) progression of measurable disease, or (c) progression of non-measurable disease as defined below:\n\n  1. By PSA: two consecutively rising PSA values, at least 7 days apart, each ≥ 1.0 ng\u002FmL and ≥ 50% above the minimum PSA observed during castration therapy or above the pre-treatment value if there was no response.\n  2. By measurable disease: Progressive disease by RECIST v1.1 criteria\n  3. By non-measurable disease\n\n  i. Soft tissue disease: The appearance of 1 or more new lesions, and\u002For unequivocal worsening of non-measurable disease when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response.\n\nii. Bone disease: Appearance of 2 or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre-castration studies if there was no response. Increased uptake of pre-existing lesions on bone scan does not constitute progression.\n\n* Castration status confirmed by serum testosterone level \\<50ng\u002FdL\n* ECOG Performance Status of 0 or 1.\n* Adequate liver function:\n\n  1. Bilirubin \\<2.0 x institutional upper limit of normal (UNL)\n  2. AST (SGOT) \\<2.5 x UNL\n  3. ALT (SGPT) \\<2.5 x UNL\n* Acceptable renal function\n\n  a) Serum creatinine \\<2.0 x UNL\n* Acceptable hematologic function:\n\n  1. Absolute neutrophil count (ANC) \\> 1.0 x10\\^9 cells \u002FL)\n  2. Platelet counts \\> 100 x 10\\^9 \u002F L)\n  3. Hemoglobin \\>9 g\u002FdL\n\nExclusion Criteria:\n\n* PSA \\>20ng\u002FdL within the 4 weeks prior to signing ICF\n* Previously treated with three or more FDA-approved androgen\u002FAR signaling inhibitors (ASI) (e.g., abiraterone, enzalutamide, apalutamide, darolutamide). No minimum number of ASI is required.\n* Prior chemotherapy for mCRPC. However, prior chemotherapy administered for mCSPC is allowed unless the disease progression to CRPC occurred within 12 months from the last dose of chemotherapy.\n* Prior treatment with Sipuleucel-T or supraphysiologic dose of testosterone treatment for prostate cancer.\n* Prior systemic treatment with ASI, PARP inhibitor or Radium-223 or other systemic anti-cancer therapy for prostate cancer within 4 weeks prior to start of treatment.\n* Prior prednisone \\>10mg (or its equivalent) within 2 weeks prior to registration.\n* Prior immunotherapy or Lu177 PSMA radioligand therapy within 6 weeks prior to registration.\n* Prior palliative radiotherapy within 2 weeks prior to registration.\n* Radiographic evidence of hepatic metastases\n* Use of narcotics including tramadol or stronger for cancer-related pain within 4 weeks prior to signing ICF. Use of NSAIDs or acetaminophen is allowed.\n* Active autoimmune disease requiring systemic corticosteroids of prednisone greater than 10mg a day or the equivalent dose of other corticosteroids.\n* Known active HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 infection. Testing is not required. Note: Participants with resolved, historic HIV, Hepatitis B or Hepatitis C or Human T cell Lymphotropic virus (HTLV)-1 will be assessed by the PI and deemed eligible if their viral infections are in remission: without detectable viruses and secondary immunodeficiency, and without requiring any treatments that affects immune function. Eligibility will be determined after a discussion with the PI and adequate standard clinical tests are acquired to prove that they are in remission.\n* Active infection requiring parenteral antibiotic therapy or causing fever (temperature \\>100.5 in Fahrenheit scale) within 1 week prior to registration.\n* Life expectancy of less than 6 months prior to signing ICF.\n* Any medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives.",{"count":216,"type":22},26,[218],"PHASE2","This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients with metastatic castration resistant prostate cancer (mCRPC).",[221],"Metastatic Castration-resistant Prostate Cancer",[223,224],"Sipuleucel-T","Bipolar Androgen Therapy",{"date":110,"type":33},{"date":227,"type":33},"2023-12-20",{"date":229,"type":22},"2028-03",{"name":39,"class":40},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":247,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":41},"100412057","phase-2-merck-iit-rrp-pembro-and-lenvatinib-100412057","NCT04645602","Merck IIT: RRP Pembro and Lenvatinib","A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients","Inclusion Criteria:\n\n\\- Participants must have histologically or cytologically confirmed respiratory papillomas with radiologic evidence of lung involvement. Subjects can have measurable or non-measurable\\* pulmonary disease based on RECIST 1.1. Non-measurable disease based on RECIST 1.1 is defined as lesions with a short axis less than 10 mm\n\n* For those patients with non-measurable pulmonary disease, participants must have disease at other sites such as the larynx and trachea and must have undergone \\> 3 surgical procedures over a 12-month period.\n* Be required to provide tissue from a newly obtained biopsy of a lesion or an archived specimen. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to the first dose of study drug. Subjects for whom newly obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the PI.\n* Have confirmed human papillomavirus-associated lesions based on in-situ hybridization testing and\u002For polymerase chain reaction which may be performed on a newly obtained biopsy or archived sample.\n* Age ≥18 years.\n* ECOG performance status of 0 to 1.\n* Participants must have adequate organ and marrow function as defined below:\n\n  \\---- Absolute neutrophil count (ANC) ≥1500\u002FμL\n\n  \\---- Platelets ≥100 000\u002FμL\n\n  \\---- Hemoglobin ≥9.0 g\u002FdL or ≥5.6 mmol\u002FL (a)\n  * Creatinine OR Measured or calculated (b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × institutional ULN OR ≥30 mL\u002Fmin for participant with creatinine levels \\>1.5 × institutional ULN\n  * Total bilirubin ≤1.5 × institutional ULN OR direct bilirubin ≤ institutional ULN for participants with total bilirubin levels greater than or equal to 1.5× institutional ULN\n  * AST (SGOT) and ALT (SGPT) ≤2.5 × ULN (≤5 × institutional ULN for participants with liver metastases)\n  * TSH Institutional normal limit\n  * Free T4 Institutional normal limit\n  * Amylase less than or equal to 1.5 x institutional ULN\n  * Lipase less than or equal to 1.5 x institutional ULN\n  * International normalized ratio (INR) OR prothrombin time (PT)\n  * Activated partial thromboplastin time (aPTT)\n\n    * 1.5 × institutional ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n  * ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n    1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC)transfusion within last 2 weeks.\n    2. Creatinine clearance (CrCl) should be calculated per institutional standard. -- Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Adequately controlled blood pressure with or without antihypertensive medications defined as systolic BP ≤ 140 mmHg and diastolic BP ≤ 90 mmHg at screening with no change in antihypertensive medications within 1 week prior to screening.\n* Female subject of childbearing potential must have a negative serum pregnancy test within 28 days of the first dose of study drug\\*. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n  \\*Please refer to the study calendar for requirements regarding a pregnancy test 24 hours prior to receiving any dose of study medication upon subject enrollment into the study.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n  * Is not a WOCBP as defined below. OR\n  * Is a WOCBP and must be willing to use 2 methods of birth control, or abstain from heterosexual activity during the intervention period and for at least 120 days after the last dose of pembrolizumab or 30 days post lenvatinib, whichever occurs last.\n\nWomen of childbearing potential are those who have not been surgically sterilized or have not been free from menses for greater than 1 year. The methods of surgical sterilization include having had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), tubal ligation (having your tubes tied), and transvaginal occlusion (blocking the tubes with a coil). The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention - A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.\n\n* If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months (or 120 days) after completion of pembrolizumab\n* Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of Lenvatinib:\n\n  * Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent.\n\nOR\n\n• Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n* Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n* Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed\n\n  * Ability to complete Patient Medication and Blood Pressure diaries by themselves or with assistance.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to study enrollment.\n\nNote: Participants must have recovered from all AEs due to previous therapies to ≤Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.\n\nNote: If participant received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting study treatment. Withhold lenvatinib for at least 7 days prior to elective major surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. Endoscopic debridement of RRP lesions is NOT considered a major surgery.\n\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has had major surgery within 3 weeks prior to first dose of study interventions. Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n* Has received a live vaccine within 30 days prior to the first dose of study drug.\n\nExamples 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\n* Is currently participating in or has participated in a study of an investigational agent within 4 weeks prior to the first dose of study treatment. NOTE: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.\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 drug.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. NOTE: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, well-differentiated thyroid cancer, follicular lymphoma, carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) invasive cancer derived from RRP, or other indolent malignancy not requiring active treatment are not excluded.\n* History of allergic reactions (greater than or equal to Grade 3) attributed to compounds of similar chemical or biologic composition to pembrolizumab or lenvatinib and\u002For any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the 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, etc.) is not considered a form of systemic treatment.\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 Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA is detected) infection. NOTE: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has urine protein greater than or equal to 1 g\u002F24 hours. Note: Participants with proteinuria \\> 2+ (greater than or equal to100 mg\u002FdL) on urine dipstick testing (urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n\nNote: Urine dipstick is the preferred method for testing urinary protein, however, urinalysis may be used if the use of urine dipsticks is not feasible.\n\n* Electrolyte abnormalities that have not been corrected.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia associated with hemodynamic instability and requiring medical treatment at screening. Note: Medically controlled arrhythmia would be permitted.\n* Has a LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition (MUGA) or echocardiogram (ECHO).\n* Prolongation of QTcF interval to \\>480 msec, as calculated by either the Bazett or Fridericia formula, as per institutional standard.\n* Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion\u002Finfiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n* Has a known history of colitis.\n* Has clinically significant gastrointestinal malabsorption syndrome or any other condition that might affect the absorption of lenvatinib.\n* Has preexisting greater than or equal to Grade 3 gastrointestinal or non-gastrointestinal fistula\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a known history of posterior reversible encephalopathy syndrome (PRES).\n* Participants with history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pembrolizumab and\u002For lenvatinib, and breastfeeding should be discontinued.",{"count":80,"type":22},[218],"This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP).\n\nThe names of the study drugs involved in this study are:\n\n* Pembrolizumab\n* Lenvatinib",[242,243,244],"Human Papilloma Virus","Recurrent Respiratory Papillomatosis","Pulmonary Disease",[242,243,246],"Pulmonary Involvement",{"date":112,"type":33},{"date":249,"type":33},"2025-07-18",{"date":251,"type":22},"2027-12",{"name":39,"class":40},{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":258,"eligibilityCriteria":259,"healthyVolunteers":12,"sex":18,"minAge":189,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":80},"100592686","phase-2-an-exploratory-study-of-the-potential-for-rational-immune-system-manipulation-to-prevent-emergence-of-synucleinopathy-manifestations-in-persons-with-rem-sleep-behavior-disorder-rbd-100592686","NCT06996652","An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)","PRISMS","Inclusion Criteria:\n\n* Males, or females who are either\n\n  1. post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or\n  2. practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.\n* Diagnosis of idiopathic REM sleep behavior disorder Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:\n\n  1. History of Dream Enactment Behavior during sleep and\n  2. Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD\n* Hyposmia, defined as score \\\u003C 15th percentile for age-and gender-specific normal values\n* Not diagnosed with motor parkinsonism or Lewy body dementia\n* Have a MoCA score at screening and baseline \\>23\n* Able to speak, read and write fluently in the official language of the site's geographical region\n* Participant must be willing and able to attend all study visits as required by the study protocol\n* Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status\n* Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so\n* Participant must be able to understand the study requirements and provide written informed consent\n\nExclusion Criteria:\n\n* Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)\n* Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral\u002Fspinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.\n* As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3\n* Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures\n* History or active presence of any of the following neurological, psychiatric or medical conditions:\n\n  1. Large vessel stroke\n  2. Peripheral or CNS demyelinating disease\n  3. Chronic and\u002For recurrent fungal, bacterial or opportunistic infections\n  4. Myocardial infarction or unstable angina within the previous 12 months\n  5. Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \\> 450 msec (males) or \\> 470 msec (females).\n  6. Congestive heart failure, NYHA Class 3 or 4\n  7. Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)\n  8. Immunocompromised systemically due to continuing effects of immune suppressing medication\n  9. Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and\u002For hepatitis B core antibody (anti-HBc).\n\n     Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug\n  10. History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure\n  11. History or positive test at Screening for human immunodeficiency virus (HIV)\n  12. History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.\n  13. History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix\n  14. Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days\n  15. Seated blood pressure \\> 150\u002F90 on 3 separate determinations\n  16. Presence of hallucinations or delusions\n  17. Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis\n  18. Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral\u002Fintramuscular anti-infectives within 14 days prior to baseline\n  19. Major surgery within 12 weeks of screening\n  20. Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication\n* Any of the following laboratory abnormalities at Screening\n\n  1. Screening values for hemoglobin \\\u003C 12 g\u002Fd for men or \\\u003C 11 g\u002FdL for women or other clinically significant hematological abnormality\n  2. Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \\> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart\n  3. Serum creatinine above the ULN or eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n  4. Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding\n* Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan\n* For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells\u002FmL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \\\u003C 100 mg\u002Fday or clopidogrel (see item 10 (g) below))\n* Taking any of the following medications:\n\n  1. Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit\n  2. Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit\n  3. Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine\u002Famphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit\n  4. Antipsychotic agents, including pimavanserin\n  5. Antidepressant medications whose dose has not been stable for at least 90 days\n  6. Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept\n  7. Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents\n  8. For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \\\u003C¬ 100 mg\u002Fday or clopidogrel at a dose of 75 mg\u002Fday, but use of both in combination is permitted.\n  9. Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.\n* History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and\u002For other products in the same class\n* Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.\n* History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)\n* Positive urine drug test at screening\n* Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials","80 Years",{"count":262,"type":22},108,[218],"This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.",[266],"REM Sleep Behavior Disorder",[268],"Parkinson Disease Related Pattern","2026-06-26",{"date":132,"type":33},{"date":272,"type":22},"2026-06-29",{"date":274,"type":22},"2029-08-01",{"name":39,"class":40},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":48,"maxAge":189,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":291,"completionDateStruct":292,"leadSponsor":294,"locationsCount":41},"100645343","phase-2-effects-of-nimodipine-on-alcohol-drinking-100645343","NCT07681869","Effects of Nimodipine on Alcohol Drinking","A Randomized Controlled Study on the Effects of Nimodipine on Alcohol Drinking Among Adults Who Are Heavy Alcohol Drinkers","Inclusion Criteria:\n\n1. Ages 21-50 (The lower limit is to avoid offering alcohol to individuals below the drinking age of 21. The upper age is determined by experience recruiting for our prior studies).\n2. Ability to read English at 6th grade level or higher.\n3. Meet DSM-V criteria for at least moderate AUD.\n4. Average weekly alcohol consumption of 30-70 standard drinks for men and 20-65 drinks for women. The lower limits are consistent with the lower sex-specific cut-offs defining high-risk drinking based on World Health Organization Risk Levels (WHO, 2000); the upper limits are designed to avoid recruiting participants whose drinking is likely to exceed the number of drinks available in the alcohol drinking paradigm (ADP).\n\nExclusion Criteria:\n\n1. Individuals who are seeking alcohol treatment or have been in alcohol treatment within the past 6 months.\n2. Meet current DSM-V criteria for substance use disorder, except for tobacco use disorder or mild cannabis use disorder.\n3. Positive urine drug screens at more than 1 baseline appointment for opiates, cocaine, benzodiazepines, and barbiturates.\n4. Psychotic or other severe psychiatric disorders as determined by clinical evaluation.\n5. Regular use of psychoactive drugs, except for individuals on a stable dose of an antidepressant for at least 2 months.\n6. Medical conditions that would contraindicate the consumption of alcohol or use of nimodipine including untreated or not adequately controlled hypertension or hypotension. Blood pressure at or below 100\u002F65 will be exclusionary.\n7. Heart rate of less than 50 bpm.\n8. Clinically significant abnormalities in screening laboratories, including aspartate aminotransferase (AST) \\>3 times upper limit of normal (ULN); alanine aminotransferase (ALT) \\> 3 times ULN; total bilirubin \\>1.5 times ULN; serum creatinine \\>2.0 times ULN.\n9. Concurrent use of the following medications: CYP3A4 inhibitors and inducers, other calcium channel blockers, or other blood pressure lowering medications.\n10. Neurological trauma or disease, delirium, or hallucinations, or clinically significant or unstable medical conditions, including uncontrolled hypertension or diabetes, or significant cardiac, pulmonary, renal, hepatic, endocrine, or other systemic diseases, which in the opinion of the study physician and PI, may put the patient at risk because of participation in the study.\n11. Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-Ar) scores of 8 or greater or a history of significant repeated alcohol withdrawals to reduce the likelihood of withdrawal symptomatology if subjects reduce their drinking.\n12. Women who are pregnant or nursing.\n13. Participants who refuse to use a reliable method of birth control from the time of first medication administration to 7 days after. These include oral contraceptives, contraceptive sponge, patch, double barrier (diaphragm\u002Fspermicidal or condom\u002Fspermicidal), intrauterine contraceptive system, etonogestrel implant, medroxyprogesterone acetate contraceptive injection, complete abstinence from sexual intercourse, hormonal vaginal contraceptive ring, surgical sterilization, or true abstinence.\n14. Subjects who report disliking spirits will be excluded because hard liquor will be provided during the ADP.\n15. Subjects who have taken any investigational drug within 4 weeks of the anticipated date of the first study dose.\n16. Individuals who report heavy drinking days in the 2 days prior to their intake appointment but have a negative ethyl glucuronide (EtG) test to rule out subjects who are misrepresenting their drinking history.\n17. Subjects who have donated blood within the past 6 weeks.\n18. Heart rate of less than 50 bpm.\n19. Subjects with a history or presence of cirrhosis.\n20. MRI contraindications including incompatible implants, other metal in body (e.g. pacemakers, shrapnel, metal implants) or claustrophobia.",{"count":284,"type":22},40,[218],"This is a randomized placebo-controlled trial (RCT). Participants will be non-treatment seeking adults, 21-50 years of age, with Alcohol Use Disorders. All will participate in two alcohol drinking paradigm (ADP) sessions separated by at least 3 days at The Clinical Neuroscience Research Unit (CNRU). Participants will stay overnight and receive nimodipine (90 mg\u002Fdose) or placebo every six hours during an 18-hour period prior to each ADP. MEG and\u002For EEG data will be collected before the first dose and after the third dose of nimodipine (NIM) or placebo (PLA). Adverse events will be closely monitored during this period. During the ADP participants will receive a priming dose of alcohol followed by a one-hour monitoring period. This will be followed by three one-hour self-administration periods; during each hour they will be able to choose between four drinks or monetary equivalents of these drinks (total of 12 drinks over three hours). ADP outcomes will include number of drinks consumed, alcohol craving, mood changes and alcohol effects, physiological measures (heart rate, blood pressure), as well as breath alcohol levels. Investigators anticipate having to recruit up to 40 participants to achieve 20 completers.",[288],"Alcohol Use Disorder","2026-06-25",{"date":112,"type":33},{"date":160,"type":22},{"date":293,"type":22},"2032-06-30",{"name":39,"class":40},{"id":296,"slug":297,"hasResults":12,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":302,"maxAge":303,"enrollmentInfo":304,"targetDuration":4,"studyType":23,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":311,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":41},"100645259","peer-delivered-youth-suicide-prevention-in-nepal-100645259","NCT07680179","Peer Delivered Youth Suicide Prevention in Nepal","Innovations for Peer-delivered and Family-engaged Brief Interventions for Youth Suicide in Nepal: A Pilot Hybrid Type 2 Implementation Study","Inclusion Criteria:\n\nPeer Volunteers\n\n* Age ≥18 years\n* No current untreated mental disorder or suicide risk, as assessed and confirmed by a Nepali mental health specialist (MD or PhD)\n* Meets hiring and eligibility criteria of the local implementing partner NGO\n* Fluent in spoken Nepali\n\nTrial Youth Patient Participants\n\n* Age 12-24 years\n* Resident of the study site\n* Screens positive to the Nepali Ask Suicide Screening Questions or a lifetime history of a suicide attempt\n* Ability to provide informed consent or assent\n* For participants under 18 years of age, written informed consent from a legal guardian\n* Fluent in Nepali\n\nFamily Members (intervention group only)\n\n* Family member (defined as any individual that is a parent, grandparent, aunt\u002Funcle, or cousin as well as significant others) selected by the youth participants enrolled in the study\n* Resident of the study site\n* Over 18 years of age\n* Ability to provide informed consent or assent\n* Fluent in Nepali\n\nExclusion Criteria:\n\nPeer Volunteers\n\n* Plans to leave the peer volunteer role within the next 6 months\n* Unable to provide voluntary informed consent for any reason\n\nTrial Youth Patient Participants\n\n* Requires immediate psychiatric hospitalization at the time of assessment\n* Unable to provide informed consent or assent due to impaired decision-making capacity\n* Participants under 18 years of age without written informed consent from a legal guardian\n* Planning to leave the study area in the next 6 months\n\nFamily Members\n\n* Requires immediate psychiatric hospitalization at the time of assessment\n* Unable to provide informed consent or assent due to impaired decision-making capacity\n* Planning to leave the study area in the next 6 months","12 Years","24 Years",{"count":305,"type":22},160,[25],"South Asia has the highest suicide rate in the world with important risk profile differences from high-income settings. Investigators will conduct formative research to co-design a package of brief interventions and implementation strategies to prevent youth-suicide and then test the package in a pilot feasibility hybrid type 2 cluster randomized controlled trial in Nepal. Potential health impacts may be substantial as results can be applied not only in similar South Asian primary healthcare contexts, but also in low-resource settings in the US and abroad, where the suicide burden remains high.\n\nUsing experience-based co-design and equity-focused implementation frameworks, this study will assess the feasibility and acceptability of a Youth-focused, Peer-delivered, Family-engaged Suicide Prevention Package (YPF-SuPP) integrated within existing mhGAP services in Nepal's decentralized primary healthcare system. This pilot trial will generate preliminary data to inform the design of a future fully powered effectiveness trial and potential scale-up of youth suicide prevention strategies.",[309,310],"Suicide","Suicide Prevention",{"date":112,"type":33},{"date":313,"type":22},"2026-06",{"date":315,"type":22},"2028-06",{"name":39,"class":40},{"id":318,"slug":319,"hasResults":12,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":4,"eligibilityCriteria":323,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":325,"briefSummary":326,"conditions":327,"keywords":329,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":333,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":339},"100587064","phase-2-circulating-tumor-dna-100587064","NCT06923527","Circulating Tumor DNA","A Single Arm Phase II Trial of Circulating Tumor DNA-guided Adjuvant Therapy With Elacestrant in Adults With Hormone Receptor Positive HER2 Negative Breast Cancers at Risk for Late Recurrence (CATE)","Inclusion Criteria for Screening:\n\n1. Adults aged 18 years and older.\n2. Previous diagnosis of anatomic stage IIB or anatomic stage III histopathologically or cytologically confirmed ER+, HER2-, breast cancer per local laboratory as per ASCO\u002FCAP guidelines. In the context of this trial, ER status will be considered positive if \\>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry, with or without progesterone receptor positivity. Patients with PR positive but ER-negative are not eligible.\n3. Participants must have been diagnosed with ER+HER2- breast cancer at least five years ago and no more than 20 years ago and must have completed adjuvant endocrine therapy.\n4. Participants must be off endocrine therapy for at least four weeks prior to screening.\n\nExclusion Criteria for Screening:\n\n1. Known current metastatic disease.\n2. Known contraindication to receiving elacestrant as per FDA package insert.\n3. Current treatment with endocrine therapy.\n4. Prior treatment with elacestrant or other investigational SERDs.\n5. Current or past invasive cancer other than breast cancer, except:\n\n   1. Adequately treated basal or squamous cell carcinoma of the skin.\n   2. Cancer survivors of previously diagnosed invasive cancer who were treated with curative intent and have no evidence of disease recurrence for five years or more and are considered low risk for future recurrence by the treating physician.\n6. Patients in the screening phase, or in the randomized trial (treatment phase), cannot start receiving therapy on another therapeutic clinical trial.\n7. Current use of strong and moderate CYP3A4 inducers\u002Finhibitors or other prohibited concomitant medication unless an acceptable substitute is available, and the prohibited medication is discontinued at least five half-lives prior to initiation of elacestrant.\n8. Participants who are pregnant.\n\nInclusion Criteria for Treatment:\n\n1. ctDNA positivity by NEXT Personal assay.\n2. No evidence of metastatic disease on staging scans.\n\n   a. If imaging, after review with a radiologist, is low probability for metastatic disease, patients may proceed with enrollment. Patients with suspicious but inconclusive imaging results should undergo a diagnostic biopsy; if biopsy is negative patients are eligible for enrollment. Patients with positive imaging that is conclusive of metastatic disease, or biopsy proven metastatic disease, are not eligible.\n3. At the time of informed consent signature for treatment, participants may be either postmenopausal, premenopausal, or perimenopausal.\n\n   a. Postmenopausal status is defined by: i. Age ≥60. ii. Age \\\u003C60 and amenorrhea for 12 or more months (without an alternative cause) and FSH and estradiol level within postmenopausal range per local laboratory reference.\n\n   iii. Documentation of bilateral oophorectomy, at least one month before first dose of trial therapy.\n\n   b. Premenopausal and perimenopausal participants must be willing to concurrently receive an LHRH agonist, and the LHRH agonist must be initiated at least three to four weeks before the start of elacestrant and are planning to continue LHRH agonist treatment during treatment with elacestrant. This is based on the current FDA approval of elacestrant in the metastatic setting which is limited to postmenopausal participants.\n\n   c. Premenopausal or perimenopausal participants must be willing to use a highly effective method of contraception for the duration of trial treatment and for 120 days after the last dose of elacestrant OR if using barrier method of contraception must be willing to use a second form of contraception like occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository.\n\n   i. Highly effective methods of contraception are non-hormonal (cooper) intrauterine device (IUD), surgical sterilization (bilateral tubal occlusion\u002Fligation, partner who has had a vasectomy), and sexual abstinence.\n4. ECOG performance status of 0 or 1.\n5. Patient has adequate bone marrow and organ function, as defined by the following laboratory values:\n\n   1. Absolute neutrophil count (ANC) \\>1.0 x 109\u002FL.\n   2. Platelets \\>100 x 109\u002FL.\n   3. Hemoglobin \\> 8.0 g\u002FdL.\n   4. Potassium, sodium, calcium, and magnesium CTCAE v5.0 grade \\\u003C1.\n   5. Cockcroft-Gault based creatinine clearance \\>50 mL\u002Fmin.\n   6. ALT and AST \\\u003C3 x ULN and total serum bilirubin \\\u003C1.5 x ULN.\n   7. Hypercholesterolemia and hypertriglyceridemia CTCAE v5.0 grade \\\u003C1.\n\nExclusion Criteria for Treatment:\n\n1. Any concurrent severe and uncontrolled medical condition that would, in the sponsor-investigator's opinion, cause unacceptable safety risks or compromise compliance with the protocol including but not limited to:\n2. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication (uncontrolled Crohn's disease or ulcerative colitis, uncontrolled chronic nausea, vomiting, diarrhea, malabsorption, or small bowel resection).\n3. Females who are pregnant or breastfeeding.\n4. Moderate to severe liver impairment (Child-Pugh Class B and C).\n5. Hypercholesterolemia or hypertriglyceridemia \\> CTCAE v5.0 grade 1.\n6. Participants who are currently or are planning lactation during elacestrant treatment. Lactation during and at least one week following the last dose of elacestrant is not allowed",{"count":21,"type":22},[218],"This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial. Our trial will proceed in three separate phases: screening, treatment, and follow-up.",[328],"ER+ Breast Cancer",[330,331,332],"stage IIB","stage III","ctDNA",{"date":272,"type":33},{"date":335,"type":33},"2025-09-30",{"date":337,"type":22},"2027-09",{"name":39,"class":40},7,{"id":341,"slug":342,"hasResults":12,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":23,"phases":348,"briefSummary":349,"conditions":350,"keywords":352,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":354,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":360},"100573761","phase-2-trial-of-trastuzumab-deruxtecan-in-previously-treated-her2-100573761","NCT06750484","Trial of Trastuzumab Deruxtecan in Previously Treated HER2","Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer","Inclusion Criteria:\n\n1. Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific procedures or tests.\n2. Men or women ≥18 years old.\n3. Pathologically documented breast cancer that is unresectable or metastatic.\n4. 4.Tumor biopsies have always shown HER2-IHC 0 (\\\u003C10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior pathology testing according to American Society of Clinical Oncology College of American Pathologists (ASCO-CAP) guidelines.\n5. Either HR-positive or HR-negative status of the tumor per ASCO-CAP guidelines are allowed.\n6. Patients with HR-positive disease must have progressed or be intolerant to CDK 4\u002F6 inhibitors plus endocrine therapy, and patients with HR-negative disease must have received 1 line of therapy in the metastatic setting (progression on or within 6 months of neoadjuvant or adjuvant therapy will be accounted for as 1 line of prior therapy). There is no limit on number of subsequent lines of therapy for study entry. .\n7. Patients must have never been previously treated with any anti-HER2 therapy, including prior trastuzumab deruxtecan, other HER2-directed ADCs, HER2 antibodies or HER2 tyrosine kinase inhibitors\n8. Clinical or radiologic progression (during or after most recent treatment) or intolerance to therapy prior to enrollment in this trial\n9. Adequate archival tumor sample \\\u003C3 years-old available for assessment of HER2 status by IHC and by HS-HER2 quantitative assay. If archival tissue is not available or inadequate for assessment (e.g. decalcified bone, cytology, or other), a newly obtained biopsy from a metastatic site (or breast tissue if locally advanced\u002Funresectable disease as the only site of advanced disease) is required on enrolment.\n10. Presence of at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n11. ECOG PS ≤ 2.\n12. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to C1D1.\n13. Adequate bone marrow function (Table 1) within 28 days before C1D1, defined as:\n\n    1. Platelet count \\>≥100,000\u002Fmm3 (Platelet transfusion is not allowed within 1 week prior to Screening assessment).\n    2. Hemoglobin level ≥9.0 g\u002FdL (red blood cell transfusion is not allowed within 1 week prior to Screening assessment).\n    3. Absolute neutrophil count ≥1500\u002Fmm3 (granulocyte colony-stimulating factor administration is not allowed within 1 week prior to Screening assessment).\n14. Adequate renal function (Table 1) within 28 days before C1D1, defined as:\n\n    a. Creatinine clearance ≥30 mL\u002Fmin, as calculated using the Cockcroft-Gault Equation.\n15. Adequate hepatic function (Table 1) within 28 days before C1D1, defined as:\n\n    1. Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 3×ULN (\\\u003C 5×ULN in participants with liver metastases).\n    2. Total bilirubin ≤1.5 × ULN if no liver metastases or \\\u003C3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n16. Adequate blood clotting function( defined below) within 28 days before C1D1, defined as International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n\n    1. Platelet function greater than or equal to 100000\u002Fmm3 (Platelet transfusion is not allowed within 1 week prior to C1D1).\n    2. Hemoglobin greater than or equal to 9.0 g\u002FdL NOTE: Participants requiring ongoing transfusions or growth factor support to maintain haemoglobin ≥9.0 g\u002FdL are not eligible. Red blood cell transfusion is not allowed within 1 week prior to C1D1.\n    3. Absolute neutrophil count greater than or equal to 1500\u002Fmm3. (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).\n    4. Alanine aminotransferase and aspartate aminotransferase less than or equal to 3×ULN (\\\u003C 5×ULN in participants with liver metastases).\n    5. Total bilirubin less than or equal to 1.5×ULN if no liver metastases or \\\u003C 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.\n    6. Serum albumin greater than or equal to 2.5 g\u002FdL\n    7. Creatine clearance greater than or equal to 30 mL\u002Fmin as determined by Cockcroft Gault (using actual body weight).\n    8. International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time less than or equal to 1.5 x upper limit of normal\n17. Adequate treatment washout period before C1D1, defined below:\n\n    1. Major surgery minimum washout period of greater than or equal to 4 weeks\n    2. Radiation therapy including palliative stereotactic radiation therapy to chest minimum washout period greater than or equal to 4 weeks\n    3. Palliative stereotactic radiation therapy to other anatomic areas including whole brain radiation minimum wash out period of greater than or equal 2 weeks\n    4. Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal to 3 weeks\n    5. Anti-Cancer chemotherapy \\[Immunotherapy (non-antibody based therapy)\\], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal 3 weeks\n    6. Targeted agents and small molecules minimum washout period greater than or equal 2 weeks or 5 half-lives, whichever is longer\n    7. Cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of pleural effusion, ascites or pericardial effusion minimum washout period greater than or equal to 2 weeks prior to screening assessment\n    8. Any monoclonal antibody treatment minimum washout period greater than or equal to 3 elimination half-lives of the inhibitor\u002Fantibody\n18. Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of T-DXd. Women of childbearing potential are defined as those who are not surgically sterile (i.e. underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n19. Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3 from the time of screening (those using hormonal methods must have been stable on their chosen form of contraception for 3 months prior to study entry) and must agree to continue using such precautions for 7 months after the last dose of T-DXd. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of T-DXd. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n20. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom from screening to 4 months after the final dose of T-DXd. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, as described in Table 3. In addition, male patients should refrain from fathering a child or freezing or donating sperm from the time of enrolment, throughout the study and for 4 months after the last dose of T-DXd. Preservation of sperm should be considered prior to enrolment in this study.\n21. Female subjects must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrolment in this study.\n\nExclusion Criteria:\n\n1. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   1. History of myocardial infarction within 6 months before enrolment.\n   2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV).\n   3. Corrected QT interval (QTc) Fridericia prolongation to \\>470 ms (females) or \\>450 ms (male) based on average of Screening 12 lead ECG.\n2. Uncontrolled or significant respiratory disease criteria, including any of the following:\n\n   1. Has a history of (noninfectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.\n   2. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease, symptomatic, recurrent and uncontrolled pleural effusion etc.)\n   3. Any autoimmune, connective tissue or inflammatory disorders, including Rheumatoid arthritis, Sjogren's, and sarcoidosis, where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for participants who are included in the study.\n   4. Prior pneumonectomy (complete)\n3. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids to control associated symptoms.\n\n   1. Subjects with clinically inactive brain metastases may be included in the study.\n   2. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrolment.\n4. Has history of another primary malignancy, except for:\n\n   1. Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product, or history of severe hypersensitivity reactions to monoclonal antibodies.\n6. Has an uncontrolled infection requiring ongoing IV antibiotics, IV antivirals, or IV antifungals.\n7. Has known history of human immunodeficiency virus (HIV) infection with detectable viral load or CD4 count \\\u003C 200 cells per cubic millimeter or active hepatitis B ( HBsAg positive) or C (HCV positive RNA) infection.\n8. Substance abuse, medical conditions such as clinically significant cardiac or pulmonary diseases or psychological, social, familial, or geographical conditions, that would, in the opinion of the Investigators, increase the safety risk to the subject or interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n9. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator \\[e.g., Grade 2 chemotherapy-induced neuropathy, fatigue, residual endocrinopathies from use of immunotherapy such as hypothyroidism\u002Fhyperthyroidism, type 1 diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)\\].\n10. Is pregnant or breastfeeding, or planning to become pregnant.\n11. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention. Note: Participants, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study intervention.\n12. Otherwise considered inappropriate for the study by the Investigator.",{"count":284,"type":22},[218],"The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.",[351],"Breast Cancer Metastatic",[353],"HER2-IHC 0",{"date":272,"type":33},{"date":356,"type":33},"2025-06-20",{"date":358,"type":22},"2028-12-31",{"name":39,"class":40},3,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":368,"maxAge":260,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":375,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":41},"100639756","phase-2-the-efficacy-of-psilocybin-therapy-for-depression-in-parkinsons-disease-100639756","NCT07610369","The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","PSI-PD","Inclusion Criteria:\n\n* Able to understand and provide informed consent\n* Comfortable speaking and writing in English\n* Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an \"on\" phase (time when medication\u002FDBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)\n* Have no changes in medication or major surgical procedures anticipated for treatment duration\n* Have a score \\>\u002F=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline.\n* For people who can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy.\n* Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study.\n* Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions.\n* Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree not to use products or substances containing Δ9-tetrahydrocannabinol (THC) and\u002For cannabidiol for at least 7 days prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to not use non-prescribed narcotics (eg. heroine, fentanyl), depressants (eg. Barbiturates, benzodiazepines) and\u002For inhalants for the duration of participation in the trial.\n* Agree not to consume alcoholic beverages for at least 24 hours prior to and 24 hours following each psilocybin administration session.\n* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating care and is available for consultation with the study medical monitor.\n\nExclusion Criteria:\n\n* Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.\n* Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\\u003C24.\n* Symptomatic orthostatic hypotension.\n* Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and\u002For TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.\n* Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial.\n* Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial.\n* Current severity of psychiatric symptoms warranting immediate treatment as determined by the study medical staff (e.g. due to inability to provide for basic needs\u002Fsafety). The study medical staff will assess these individuals, determine the appropriate level of care, and coordinate with the individual's primary providers to ensure close follow-up.\n* High risk of self-harm\u002Fsuicide, as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) risk screen, specifically: participant answers \"yes\" to item 4 or 5 suggesting intent to act on suicidal thoughts OR participant has made a serious suicide attempt within the 12 months prior to entry into this trial.\n* History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features.\n* History of delusional symptoms or any other psychotic symptoms accompanied by a loss of insight. Exceptions may be made at the investigators' discretion in cases of a history of psychotic symptoms that were attributable to substance or medication use.\n* Current delusional symptoms or any other psychotic symptoms accompanied by a loss of insight.\n* History of a schizophrenia spectrum disorder in a first-degree relative.\n* History of bipolar disorder 1 in a first-degree relative, in whom illness onset was prior to age 40.\n* Current or history of meeting DSM-5 criteria for a bipolar disorder.\n* Current or history within the last 2 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder, excluding caffeine.\n* Currently meeting DSM-5 criteria for another psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin treatment procedures as determined by the investigators.\n* History of meeting DSM-5 criteria for Hallucinogen Persisting Perception Disorder (HPPD).\n* History of using any psychedelic substances including psilocybin, lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy-methamphetamine (MDMA), or methylone during the past 6 months at dosages and\u002For frequencies determined clinically significant by the investigators.\n* Cancer with known central nervous system (CNS) involvement, CNS infection, or other major CNS disease aside from PD.\n* Epilepsy or other seizure disorder in adulthood.\n* Supplemental oxygen requirement.\n* Allergy or intolerance to any of the materials contained in the drug products.\n* Renal insufficiency defined as creatinine clearance \\\u003C 40 ml\u002Fmin using Cockraft and Gault equation\n* Insufficiently managed endocrine conditions, including diabetes mellitus and clinically significant thyroid dysfunction.\n* Cardiovascular conditions, including:\n\n  * Elevated blood pressure defined as systolic blood pressure (SBP) \\>150 or diastolic blood pressure (DBP) \\>95 taken during Enrollment\n  * Tachycardia defined as heart rate (HR) \\>90 beats per minute taken during Enrollment\n  * Bradycardia defined as HR \\\u003C50 bpm taken during Enrollment\n  * Angina\n  * History of stroke within the past year\n  * Clinically significant ECG abnormality as determined by the investigators, including but not limited to QTc \\> 450\n* Hepatic dysfunction as indicated by any of the following laboratory values:\n\n  * AST \\> 3 x upper limit of normal\n  * ALT \\> 3 x upper limit of normal\n  * Total bilirubin \\> 3.0 mg\u002Fdl\n* Use of any of the following concomitant medications AND inability\u002Funwillingness to discontinue for at least 5 times the elimination half-life of the agent (specific exceptions are noted) prior to psilocybin administration, including:\n\n  * Agents that may be associated with serotonin syndrome:\n\n    * MAO inhibitors (participants must have discontinued 2 weeks prior to baseline)\n    * St. John's Wort\n    * S-adenosyl-methionine (SAM-e)\n    * 5-Hydroxytryptophan (5-HTP)\n    * Dextromethorphan\n    * Opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n    * Lithium\n    * Linezolid\n    * Buspirone\n  * Agents that may interact with psilocybin metabolism\u002Feffects:\n\n    * Serotonin antagonists (e.g., cyclobenzaprine, ondansetron)\n    * Antipsychotics\n    * Other dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine)\n    * Nicotine\n    * Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g. valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors)\n    * L-methyl folate (\\>\u002F= 7.5mg\u002Fday)\n    * Efavirenz\n  * Agents that may increase the risk of psychotic symptoms:\n\n    * Stimulants (e.g. modafinil, methylphenidate, atomoxetine, methamphetamine, cocaine, amphetamine derivatives)\n    * Anticholinergics (e.g. benztropine, trihexyphenidyl, scopolamine, hyoscyamine)\n    * Systemic steroids\n  * Tricyclic antidepressants\n* Other medical condition or diagnosis, concomitant medication(s), physical exam finding, laboratory abnormality or health risk identified that precludes participation in study procedures due to safety or feasibility concerns at the discretion of the investigators.","40 Years",{"count":284,"type":22},[218],"The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.",[373,374],"Depression","Parkinson's Disease (PD)",[376,373,377,378,379],"Parkinson's Diesease","Psilocybin","Psilocybin therapy","Movement disorder","2026-06-24",{"date":272,"type":33},{"date":313,"type":22},{"date":384,"type":22},"2030-06",{"name":39,"class":40},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":403,"locationsCount":118},"100610116","shared-decision-making-to-treat-or-prevent-stop-hiv-in-criminal-legal-involved-populations-r33-100610116","NCT07223398","Shared Decision Making to Treat Or Prevent (STOP) HIV in Criminal Legal Involved Populations (R33)","STOP (Shared Decision Making to Treat Or Prevent) HIV in Criminal Legal Involved Populations","Inclusion Criteria:\n\n* able to provide written informed consent in English or Spanish;\n* living in the community of Western, CT, Dallas and Tarrant Counties in TX and Madison County, KY (potential for Fayette county as well);\n* Those with current justice involvement (with in the past 12 months) (e.g., prison, jail, community supervision);\n* willing to have HIV testing to determine negative or positive status;\n* persons with HIV who report not currently taking ART in past 6 months OR persons who test negative for HIV who report not taking PrEP that have a PrEP indication in past 12 months, including (i) condomless sexual intercourse; and\u002For (ii) sharing IDU equipment with HIV positive or unknown status partner; and\u002For (iii) bacterial STI and;\n* Having a history of opioid and\u002For stimulant use in the last 12 months within the community.\n\nExclusion Criteria:\n\n* severe medical or psychiatric disability making participation unsafe;\n* unable to provide consent.\n* persons self-reporting pregnancy",{"count":170,"type":22},[25],"This study seeks to compare the effectiveness of two Patient Navigation models of care to evaluate the proportion who initiate PrEP\u002FART and substance use\u002Fsubstance use disorder (SU\u002FSUD) treatment. A standardized Patient Navigation (PN) arm will be compared with a shared decision-making model in the form of Patient Choice (PC) through the offer of a menu of existing community-based health service delivery options. This design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of Patient Navigation and Patient Choice models of care as potentially useful re-entry and relapse prevention treatment options.",[397],"Substance Use Disorders","2026-06-22",{"date":289,"type":33},{"date":401,"type":33},"2025-11-24",{"date":315,"type":22},{"name":39,"class":40},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":17,"sex":18,"minAge":48,"maxAge":368,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":412,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":41},"100627493","early-phase-1-psilocybin-microdosing-on-cognition-mood-and-quality-of-life-100627493","NCT07449351","Psilocybin Microdosing on Cognition, Mood and Quality of Life","Effects of Psilocybin Microdosing on Cognition, Mood and Quality of Life: A Pilot Study","Inclusion Criteria:\n\n* No history of psychedelic use\n* Able to read, speak, and understand English\n* Able and willing to provide written informed consent, and willing to commit to study protocol\n* Women of childbearing potential must be on a highly effective birth control method\n\nExclusion Criteria:\n\n* Positive screen for recreational drugs or alcohol on test day will result in rescheduling the appointment\n* Current mood, developmental, or psychotic disorders (e.g., schizophrenia, affective disorders) per DSM-V\n* Current or past alcohol or substance use disorder per DSM-V\n* IQ \\\u003C70 on the Weschler Abbreviated Scale of Intelligence\n* Serious medical, neuro-ophthalmological, or neurological illness (e.g., cancer, seizure disorders, encephalopathy)\n* Current pregnancy, breastfeeding, or ineffective birth control methods\n* History of head trauma with loss of consciousness lasting \\>30 minutes or concussion in last 30 days\n* Any medical\u002Fneurological condition that could compromise neurocognitive performance (e.g., epilepsy, multiple sclerosis, fetal alcohol syndrome)\n* Anyone deemed unsafe to study personnel for any reason; e.g., suicidal ideation\n* Focal brain lesion seen on structural MRI\n* MRI contraindications (e.g., implanted metallic object, severe claustrophobia)",{"count":80,"type":22},[52],"This study is being conducted to evaluate how of 30 days of intermittently microdosed psilocybin affects mood, cognition, subjective well-being and structural\u002Ffunctional MRI results compared to a placebo. Investigators hypothesize that compared to placebo, 30 days of intermittently microdosed psilocybin will produce observable changes in mood, cognition, subjective well-being and MRI, in the absence of psychedelic experiences.",[415],"Psychedelic Microdosing Effects on Mood, Cognition, Subjective Well-being and MRI",[417,377,418,419,420],"Psychedelics","MRI","fMRI","Microdosing","2026-06-19",{"date":423,"type":33},"2026-06-23",{"date":425,"type":22},"2026-08-10",{"date":427,"type":22},"2028-04-01",{"name":39,"class":40},{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":260,"enrollmentInfo":437,"targetDuration":4,"studyType":23,"phases":439,"briefSummary":440,"conditions":441,"keywords":451,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":41},"100614693","phase-2-trial-comparing-standard-of-care-therapy-with-and-without-sequential-cytoreductive-intervention-for-patients-with-metastatic-foregut-adenocarcinoma-and-undetectable-circulating-tumor-deoxyribose-nucleic-acid-ctdna-levels-100614693","NCT07282912","Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Phase II Prospective, Open Label Randomized Controlled Trial Comparing Standard of Care Therapy With and Without Sequential Cytoreductive Intervention for Patients With Metastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","OLIGOMETS","Inclusion Criteria:\n\n* Has a primary diagnosis of AJCC 8th Edition Stage IV esophageal or gastroesophageal adenocarcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma, intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder adenocarcinoma, duodenal, and ampullary adenocarcinoma.\n\n  a) All participants must have confirmed histologic diagnosis of the primary tumor, which may be confirmed retrospectively by a radiologist if necessary.\n* Has a primary tumor that must be locally resectable or can be treated definitively. Primary tumors included are esophageal, gastric, duodenal, ampullary, pancreatic, cholangiocarcinoma, and gall bladder carcinoma. Primary tumors should be resectable or treatable with consolidative radiotherapy or ablative therapy such as microwave ablation or trans-arterial chemo\u002Fradioembolization (cholangiocarcinomas).\n* Has limited (2 sites) metastatic disease determined to be completely resectable or treatable with curative intention (see SOE) at the time of diagnosis. This includes:\n\n  1. Up to five pulmonary metastases amenable to wedge resection (maximum of three wedge resections) or lobectomy (single lobectomy) or consolidative radiation\u002Fablative therapy\n  2. Up to five hepatic metastases amenable to hepatectomy (segmentectomy, sectionectomy, sectorectomy, minor hepatectomy, not more than three segments), wedge resection requiring a minimum of 40% of liver parenchyma following resection based on future liver remnant or a combination of partial hepatectomy and microwave ablation or trans-arterial radioembolization (TARE).\n  3. Lymphatic metastases that are resectable or intervenable (limited to only two non-regional sites) (see Appendix 3).\n  4. Resectable peritoneal disease with a PCI of ≤6 and the ability to obtain a CC0 cytoreduction.\n  5. Distant metastasis must be limited to two of the above-mentioned sites (a-d).\n  6. If both pulmonary and liver metastasis are present (a, b), then a total of five lesions will be considered oligometastatic.\n* Patients with resected primary tumors can be included if they present with oligometastases at least six months after the completion of treatment of primary tumor with curative intent.\n* Has adequate organ function, as described below (see Appendix 4); all screening laboratory tests should be performed within 30 days prior to the first study intervention.\n* Patients must have had two concordant negative tissue informed ctDNA tests measured at different timepoints and with the second being within 45 days prior to enrollment.\n* Patients must have at least 4 months of prior effective systemic therapy.\n* Has hemoglobin ≥ 8 g\u002FdL.\n* Has ANC ≥ 1500\u002FuL.\n* Has platelet count ≥ 75000\u002FuL.\n* Has total bilirubin ≤ 1.5 times the upper limit of normal (ULN).\n* Has aspartate aminotransferase (AST) \\& alanine aminotransferase (ALT) ≤ 5 times ULN.\n* Has creatinine clearance ≥ 50 mL\u002Fmin.\n* Patient who is at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score 0-1 (see Appendix 6) at the time of randomization.\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence) during the treatment period and for at least 95 days following completion. Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for the Foundation for Blood Research (FBR). However, the participant may participate in the main study without participating in the FBR.\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\nNote: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* Has developed progressive disease on current line of systemic therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past three years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known CNS metastasis and\u002For carcinomatous meningitis.\n* Has known osseous metastasis.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has known malignant pleural effusion or previous malignant effusion previously treated at the time of enrollment.\n* Has histologic subtypes not included in the inclusion criteria (including esophageal squamous cell carcinoma, gastroenteropancreatic neuroendocrine tumors, hepatocellular carcinoma, etc.).\n* Has a primary tumor that is not amenable to the treatment modalities listed in section 3.\n* Has albumin level less than 3.0 g\u002FdL despite appropriate nutritional support. Diagnostic Assessments\n* Has detectable ctDNA at the time of enrollment.\n* Has an active infection requiring systemic therapy.\n* Has known active TB\u002FCOVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 95 days after the last study intervention.\n* Inability to receive chemotherapy and\u002For surgery and\u002For radiotherapy and\u002For ablative procedures due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.",{"count":438,"type":22},54,[218],"This is a randomized, open label, single-center, phase 2, randomized controlled trial of sequential cytoreductive intervention versus standard of care therapy for patients with intervenable oligometastatic (stage IV) cancer of the upper gastrointestinal (GI) tract and undetectable ctDNA at the time of randomization after a three-month induction chemotherapy period.",[442,443,444,445,446,447,448,449,450],"Foregut Adenocarcinoma","Esophageal Adenocarcinoma","Gastroesophageal Adenocarcinoma","Gastric Adenocarcinoma","Pancreas Adenocarcinoma","Duodenal Adenocarcinoma","Ampullary Adenocarcinoma","Gallbladder Adenocarcinoma","Intra - and Extrahepatic Cholangiocarcinoma",[452,453,454,455,456,457,458,459,460],"Undetectable Circulating Tumor-Deoxyribose Nucleic Acid (ctDNA) Levels","Oligometastasis","Esophageal adenocarcinoma","Gastroesophageal adenocarcinoma,","Gastric adenocarcinoma","Duodenal adenocarcinoma","Pancreatic\u002Fampullary adenocarcinoma","Gallbladder adenocarcinoma","Intra- and extrahepatic cholangiocarcinoma.","2026-06-17",{"date":398,"type":33},{"date":464,"type":33},"2026-06-02",{"date":315,"type":22},{"name":39,"class":40},{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":473,"enrollmentInfo":474,"targetDuration":4,"studyType":23,"phases":475,"briefSummary":476,"conditions":477,"keywords":481,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":487,"locationsCount":41},"100615328","a-feasibility-study-of-mass-based-response-drug-screening-to-guide-personalized-hyperthermic-intraperitoneal-chemotherapy-for-high-grade-appendiceal-and-colorectal-adenocarcinoma-with-peritoneal-metastasis-100615328","NCT07291180","A Feasibility Study of Mass-Based Response Drug Screening to Guide Personalized Hyperthermic Intraperitoneal Chemotherapy for High-Grade Appendiceal and Colorectal Adenocarcinoma With Peritoneal Metastasis","Inclusion Criteria:\n\n* Has histologically confirmed peritoneal metastases with primary diagnosis of AJCC 8th Edition Stage IV\n\n  1. Appendiceal adenocarcinoma (moderately\u002Fpoorly differentiated, and\u002For signet ring cell tumors)\n  2. Colorectal adenocarcinoma\n  3. Suspected colon, small bowel, or appendiceal adenocarcinoma in setting of unknown primary\n* Limited or no extraperitoneal metastases (any of the below)\n\n  a) Any extraperitoneal metastases must be limited, stable and treatable\n* Has adequate organ function, as described below; all screening laboratory tests should be performed within 30 days prior to the first HIPEC\n* Expected survival at the time of first HIPEC is greater than 3 months\n* Exhibits unresectable disease (bowel or mesenteric involvement) or PCI \\> 19\n\nDemographics\n\n* Adult patient at least 18 years of age at the time of signing informed consent and less than 81 years of age at the time of signing informed consent.\n* Has an ECOG performance status score of 0-2.\n\nMale Participants\n\n* A male participant must agree to use contraception (barrier birth control, abstinence) during the treatment period and for at least 95 days following completion, corresponding to time needed to eliminate any study intervention(s), and refrain from donating sperm during this period.\n\nFemale Participants\n\n* A female participant of childbearing age is eligible to participate if she is not pregnant, not breastfeeding, and agrees to use contraception (hormonal, barrier birth control, or abstinence). Should a woman become pregnant or suspect that she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nInformed Consent\n\n* The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for FBR. However, the participant may participate in the main study without participating in FBR.\n\nAlternative Eligibility\n\n* In addition to the criteria above, if a patient has undergone less than 8 rounds of chemotherapy at another institution (prior to initial diagnostic laparoscopy) and has not undergone radiation, ablative procedures, or cytoreductive surgery, then they are still eligible to enter the study at the second diagnostic laparoscopy step\n\nExclusion Criteria:\n\n* Has a positive urine pregnancy test within 3 days prior to randomization or treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Has a known allergy to medications used in this study. Note: In the event that 3 days have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for the participant to start receiving study medication.\n* Has hypoxia as defined by pulse oximeter reading \\\u003C92% at rest or requires intermittent or chronic supplemental oxygen.\n* No concurrent malignancy that may interfere with the study aims at the discretion of the investigator.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n\n* Has known significant extraperitoneal metastasis.\n* Has creatine clearance \\\u003C60 mL\u002Fm\\^2 per the Cockcroft-Gault formula\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from treatment initiation, or New York Heart Association Class III or IV congestive heart failure. Medially controlled arrhythmia stable on medication is permitted.\n* Has poorly controlled hypertension defined as SBP ≥150mmHg and\u002For DBP ≥90mmHg.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (severe dysphasia, bowel obstruction, malabsorption).\n* Has progressive disease following the first 3 months of systemic chemotherapy prior to HIPEC who is not in a stable condition to continue with the trial.\n\nPrior\u002FConcomitant Therapy\n\n* Has received radiation, ablative procedures, cytoreductive surgery, or systemic therapy including chemotherapy to treat metastatic disease within 3 months of initial laparoscopy.\n\nDiagnostic Assessments\n\n* Has an active infection requiring systemic therapy.\n* Has a known active TB\u002F COVID infection.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study intervention.\n* Has a known history of poorly controlled HIV infection despite anti-retroviral therapy.\n* Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection that is poorly controlled.\n\nNote: Testing for HBV and HCV is only required if mandated by the local health authority.\n\nOther Exclusions\n\n* Inability to receive chemotherapy due to medical\u002Finsurance reasons.\n* Requires emergency surgery due to bleeding, perforation, or obstruction.\n* Has undergone previous iterative intraperitoneal therapy.\n* Has contraindication to chemotherapy of choice.","81 Years",{"count":80,"type":22},[25],"This study will evaluate the role of mass-based response testing (MRT) to select and deliver personalized hyperthermic intraperitoneal chemotherapy (HIPEC) regimens to patients with peritoneal metastasis (PM) from high-grade appendiceal adenocarcinomas (HGAA) and colorectal cancer (CRC).",[478,479,480],"Appendiceal Cancer","Colorectal Adenocarcinoma","Peritoneal Metastases",[478,479,480,482],"Iterative Hyperthermic Intraperitoneal Chemotherapy (IHIPEC)",{"date":398,"type":33},{"date":485,"type":33},"2026-02-17",{"date":251,"type":22},{"name":39,"class":40},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":23,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":506,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":41},"100585172","hyperfractionated-dual-equivalent-fractionated-radiation-therapy-100585172","NCT06898905","Hyperfractionated Dual Equivalent Fractionated Radiation Therapy","Hyperfractionated Dual Equivalent Fractionated (HyDEF) Bridging Radiation Therapy in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma Undergoing T-Cell Redirection Therapy","HyDEF","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Adult aged 18 years or older.\n4. Histologically confirmed diagnosis of R\u002FR DLBCL with plan for CAR T or BsAb therapy at Yale New Haven Hospital.\n5. ECOG performance status 0 to 3.\n6. Ability to present for once or twice daily (M-F) fractionated radiation therapy, without contraindications for radiotherapy as determined by the treating radiation oncologist.\n7. Women of childbearing potential must have a negative serum or urine pregnancy test at screening and at time of radiation treatment planning, per standard of care and departmental standard operating procedure. Participants must agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the participants and their understanding confirmed.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Participants who are pregnant or currently breastfeeding.\n\n   a. Females who have undergone surgical sterilization or who have been postmenopausal for at least 12 months are not considered to be of childbearing potential.\n2. Participants with history of prior radiation exposure for research purposes within the past year, such that participation in this study would place them over the FDA limits for annual radiation exposure.\n3. Participants who are unable to safely receive FDG PET tracer.\n4. Any condition that would, in the investigator's judgment, interfere with full participation in the study and attending required study visits (if outpatient); pose a significant risk to the participant; or interfere with interpretation of study data.\n5. Participants who would not be anticipated to derive any clinical benefit from bridging radiotherapy, are unable to participate in twice daily radiotherapy, or have clinical contraindications to radiation therapy per treating investigator.",{"count":497,"type":22},10,[25],"This study evaluates the feasibility and safety of bridging radiation therapy, including a novel method for comparing the effectiveness of hypofractionated versus hyperfractionated radiation therapy in participants with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) undergoing T-cell redirection therapies (CAR T-cell therapy or bispecific antibodies).",[501],"Diffuse Large B-Cell Lymphoma",[494,503,504,505],"bridging radiation","once vs twice daily radiation","bulky disease lymphoma",{"date":398,"type":33},{"date":508,"type":33},"2025-10-30",{"date":510,"type":22},"2027-04",{"name":39,"class":40},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":4,"eligibilityCriteria":518,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":519,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":529,"locationsCount":41},"100566154","phase-2-efficacy-of-guselkumab-in-treating-hailey-hailey-disease-100566154","NCT06651489","Efficacy of Guselkumab in Treating Hailey Hailey Disease","Efficacy of Guselkumab in the Treatment of Hailey Hailey Disease: An Open-label, Proof of Concept Study","Inclusion Criteria:\n\n* A documented diagnosis of Hailey-Hailey disease confirmed with clinical, and histopathologic findings\n* Disease affecting more than one body site with at least moderate severity\n* If patients are taking other systemic therapies for their HHD (antibiotics, prednisone), they must be taking a stable dose of the other medication(s) for at least 3 months with no plans to change the regimen in the next 6 months. With the exception of antibiotics, methotrexate or low dose prednisone (less than 5 mg daily), use of concomitant immunosuppressants, e.g. azathioprine, etc. and biologics other than TNF-α inhibitors will not be permitted.\n* Patients must be willing to have skin biopsies, blood collection, and total body photography and to comply with clinic visits\n\nExclusion Criteria:\n\n* Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin over six months prior to first study drug administration).\n* Patients known to be HIV or hepatitis B or C positive.\n* Patients planning to receive live vaccines during the duration of the study.\n* Patients with a positive tuberculin skin test or positive QuantiFERON TB test.\n* Patients with significant hepatic impairment (Child-Pugh class B and C).\n* Patients taking immunosuppressive and biologic medications, except for methotrexate, low-dose prednisone, and TNF-α inhibitors, including but not limited to mycophenolate mofetil, azathioprine, tacrolimus, and cyclosporine.\n* Are pregnant, nursing, or planning a pregnancy while enrolled in the study or for 12 weeks after the study agent injection for women or are planning to father a child while enrolled in the study or for 12 weeks after the last study agent injection.\n* Prior biologic use within the last 3 months.\n* Participant has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients (refer to Investigator's brochure)\n* Presence of significant uncontrolled respiratory, hepatic, renal, endocrine, hematologic, neurologic, or neuropsychiatric disorders, or abnormal laboratory screening values that, in the opinion of the investigator, pose an unacceptable risk to the subject if participating in the study or of interfering with the interpretation of the data.\n* Active, untreated, acute infection, or immunocompromised to an extent that participation in the study would pose an unacceptable risk to the subject based on the investigator's clinical assessment.\n* Symptomatic herpes zoster infection within 12 weeks of screening or recurrent or disseminated (even a single episode) herpes zoster.\n* Symptomatic herpes simplex or disseminated (even a single episode) herpes simplex at the Week 0 (baseline) visit.\n* Patients with the potential for keloid formation, e.g. patients with a propensity for keloid formation, defined as a personal history of 3 or more keloids.","90 Years",{"count":497,"type":22},[218],"Hailey-Hailey disease (HHD) is a debilitating genetic skin disorder, affecting mainly body folds with erythema and painful erosions and blisters. Histopathological findings include epidermal hyperplasia, suprabasilar clefting, dyskeratosis and acantholysis of keratinocytes. A final diagnosis of HHD is usually confirmed based on clinical and histopathological findings in line with genetic testing.\n\nSeveral treatment options have been proposed for this chronic and disabling disorder, however, there is no reproducibly effective therapeutic for it.\n\nThe primary objective is to evaluate the treatment response of guselkumab. Single-center, non-randomized, single-arm, open-label, phase II trial to evaluate the efficacy and safety of guselkumab for the treatment of patients with HHD.",[524],"Hailey Hailey Disease",{"date":398,"type":33},{"date":527,"type":33},"2025-03-13",{"date":178,"type":22},{"name":39,"class":40},{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":535,"acronym":4,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":541,"conditions":542,"keywords":545,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":547,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":552,"locationsCount":41},"100554409","phase-1-patient-controlled-administration-of-liquid-acetaminophen-100554409","NCT06498713","Patient Controlled Administration of Liquid Acetaminophen","Patient Controlled Self-Administration of Oral Liquid Medication: Acetaminophen Trial","Inclusion Criteria:\n\nParticipants\n\n* Adult patients older than 18 years old admitted to SRC for total shoulder and reverse total shoulder arthroplasty\n\nNurses\n\n* The nurse who will administer acetaminophen to a study patient.\n\nExclusion Criteria:\n\nParticipants\n\n* Pregnant patient\n* Patients that cannot swallow pills or cannot take liquid (for example due to risk of aspiration)\n* Emergency surgery\n* Chronic pain\n* On home opioids, any other pain modulating medications including benzodiazepine, Neurontin, ketamine.\n* Past medical or social history of substance abuse disorder, including ethanol misuse disorder, marijuana misuse disorder\n* History of any psychiatric disorders including anxiety, depression, any cognitive dysfunction\n* Any patients who cannot provide informed consents on their own (those who would need Legally Authorized Representatives (LARs) or surrogates)\n* Liver dysfunction limiting amount of safe oral acetaminophen\n* baseline hyperbilirubinemia (ex: chronic liver disease, Gilbert's)\n* patients unable to take PO\n* Patients with neurologic, neuromuscular, or movement disorders unable to drink from a cup.\n\nNurses\n\n* any nurse who is not involved in the direct care of a study patient, or who is not comfortable with setting up the PCA pump.",{"count":538,"type":22},24,[540],"PHASE1","This is a proof of concept pilot study investigating the feasibility and acceptability of patient controlled oral medication administration, using the commonly used and low risk medication in the hospital, oral acetaminophen.",[543,544],"Pain","Pain, Postoperative",[546],"Pain Management",{"date":548,"type":33},"2026-06-18",{"date":550,"type":33},"2024-11-19",{"date":178,"type":22},{"name":39,"class":40},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":566,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":573,"locationsCount":41},"100528645","effect-of-chlorhexidine-gluconate-bladder-instillations-in-patients-with-chronic-suprapubic-catheters-on-unplanned-healthcare-encounters-and-quality-of-life-100528645","NCT06163469","Effect of Chlorhexidine Gluconate Bladder Instillations in Patients With Chronic Suprapubic Catheters on Unplanned Healthcare Encounters and Quality of Life","Instillation in Neurogenic Bladders to Decrease Unplanned Healthcare Encounters","Inclusion Criteria:\n\n* Indwelling suprapubic catheter with insertion date at least 1 year prior to study enrollment date.\n* History of urinary tract infections, treated for at least 1 positive urine culture in last 6 months\n\nExclusion Criteria:\n\n* Current radiographic evidence of urolithiasis\n* History of vesicoureteral reflux\n* History of renal transplantation\n* History of bladder augmentation\n* Inability to stop use of other rUTI prophylaxis treatments for the duration of their trial enrollment\n* Life expectancy of less than 12 months prior to consent.\n* Known hypersensitivity or allergy to chlorhexidine.\n* Women who are pregnant or breastfeeding.",{"count":127,"type":22},[25],"The goal of this clinical trial is to evaluate the feasibility and tolerability of 0.05% Chlorhexidine Gluconate (CGH) bladder instillations in an outpatient setting at the time of suprapubic catheter (SPC) exchange in patients with history of recurrent urinary tract infections (UTI). The main questions are:\n\n1. is instillation of 150mL of CGH for five-minute duration at the time of SPC exchange feasible in an outpatient setting and tolerable for patients.\n2. does this protocol decrease the rate of unplanned health care visits and improve patient quality of life.\n\nPatients will undergo the treatment protocol during their routine suprapubic catheter exchanges.",[564,565],"Neurogenic Bladder","Urinary Retention",[567,568],"recurrent UTI","bladder irrigation",{"date":548,"type":33},{"date":571,"type":33},"2024-04-01",{"date":69,"type":22},{"name":39,"class":40},{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":582,"minAge":19,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":593,"locationsCount":93},"100497770","trial-of-exercise-and-lifestyle-for-women-with-ovarian-and-endometrial-cancer-100497770","NCT05761561","Trial of Exercise and Lifestyle for Women With Ovarian and Endometrial Cancer","Trial of Exercise and Lifestyle (TEAL) for Women With Ovarian and Endometrial Cancer","TEAL","Inclusion Criteria:\n\n* have a diagnosis of epithelial ovarian cancer, fallopian tube or primary peritoneal carcinoma, stage I-IV OR have a diagnosis of advanced or metastatic endometrial carcinoma (including carcinosarcoma) AND their treatment regimen includes carboplatin and taxane (or equivalent)\n* be scheduled to receive at least 6 cycles of neoadjuvant or adjuvant chemotherapy\n* be physically able to walk without a walking aid (e.g. cane or walker)\n* be able to complete forms, understand instructions and read intervention book in English or Spanish\n* agree to be randomly assigned to either group\n* have clearance from oncologist to participate\n* be ≥ 18 years of age\n\nExclusion Criteria:\n\n* having already completed a 2nd cycle of chemotherapy\n* already practicing dietary (\\>7 servings of fruits and vegetables per day) OR physical activity guidelines (≥150 min per week of moderate to vigorous exercise and resistance training two times per week) since diagnosis\n* pregnancy or intention to become pregnant\n* recent (past year) stroke\u002Fmyocardial infarction or congestive heart failure\u002Fejection fraction \\\u003C40%\n* presence of dementia or major psychiatric disease\n* in active treatment including target or biologic therapies for any other cancer (excluding hormone therapy treatments)\n* receiving external beam radiation","FEMALE",{"count":584,"type":22},200,[25],"An anticipated 200 women with newly diagnosed ovarian and endometrial cancer scheduled to receive chemotherapy (adjuvant chemotherapy after surgery or neoadjuvant chemotherapy before surgery) will be recruited from Smilow Cancer Hospital Network at Yale Cancer Center (YCC) and Sylvester Comprehensive Cancer Center (SCCC) at University of Miami.\n\nParticipants will be randomized to an exercise and medical nutrition intervention arm with weekly counseling sessions throughout chemotherapy, or a control arm.\n\nStudy assessments will be conducted at baseline, post-chemotherapy\u002Fend of intervention and at 1-year post diagnosis. Women who are prescribed neoadjuvant therapy will have additional assessments prior to surgery.\n\nData required to calculate the primary endpoint (relative dose intensity of chemotherapy) will be abstracted from the medical record directly following each chemotherapy session.",[588],"Ovarian Cancer",{"date":398,"type":33},{"date":591,"type":33},"2023-04-19",{"date":251,"type":22},{"name":39,"class":40},""]