[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hackensack Meridian Health\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":625},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,42,69,90,117,149,173,199,220,244,267,290,319,344,364,384,402,428,453,471,489,515,539,564,592],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100053748",false,"NCT07698249","Headache Diary for Migraine Patients","Use of a Headache Calendar\u002FJournal in Patients Who Have Migraine","Inclusion Criteria:\n\n* Adults diagnosed with migraine (episodic or chronic) according to ICHD-3 criteria, with at least 3 months of confirmed diagnosis. Both episodic migraine (≤14 headache days\u002Fmonth) and chronic migraine (≥15 headache days\u002Fmonth) are eligible and will be recorded as a demographic subgroup variable.\n\nExclusion Criteria:\n\n* Individuals under the age of 18\n* Non-English speaking individuals","ALL","18 Years",{"count":18,"type":19},50,"ESTIMATED","INTERVENTIONAL",[22],"NA","Use of a headache journal\u002Fcalendar in patients who have migraine to ascertain if keeping a headache journal affects the quality of life and the headache burden.",[25],"Migraine",[27,28,29],"migraine","diary","calendar","NOT_YET_RECRUITING","2026-07-07",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":19},"2026-08-01",{"date":38,"type":19},"2029-08-01",{"name":40,"class":41},"Hackensack Meridian Health","OTHER",{"id":43,"slug":4,"hasResults":10,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100638069","NCT07624825","Emotional Awareness Therapy Study","A Feasibility Study Exploring Emotional Health Training After Moderate to Severe Traumatic Brain Injury","TREAT","Inclusion Criteria:\n\n* Moderate or Severe TBI\n* ≥18 years old\n* ≥6 months post-TBI\n* Speaks and understands English\n* Medications that can influence mood should be stable (6+ weeks)\n* Elevated alexithymia\n* Demonstrate an understanding of the study and their rights (e.g. ability to answer the following questions correctly after a review of the study details during pre-screening process)\n\nExclusion Criteria:\n\n* Premorbid neurological disorder other than TBI\n* Degenerative neurologic condition\n* Active or uncontrolled major psychiatric disorder\n* Conditions that pose safety concern to self or others, such as suicide risk\n* Visual, hearing, communication, or cognitive impairments that would impede participation\n* Active involvement in an intensive rehabilitation program\n* Individuals who recently started psychotherapy and\u002For mental health counseling",{"count":50,"type":19},48,[22],"The purpose of this study is to learn about the potential benefits of two different training programs in helping improve emotional health and well-being in people who have had a traumatic brain injury.\n\nParticipants will be assigned to one of two programs based on the time since their injury. One of the programs will teach participants how to recognize and label emotions; the other will teach healthy ways of living. Participants may improve their emotional well-being and contribute to the knowledge needed to achieve better emotional health outcomes for people with TBI.\n\nFor eligible participants, the study includes 4 assessments. Assessments may take 30-60 minutes and will be done using secure videoconferencing, phone calls, and\u002For electronic surveys. The first assessment will ask questions about demographics, the participant's brain injury, and some medical history. All assessments will include questions about emotions, emotional awareness, resilience, loneliness, and how participants manage emotions, in addition to broader wellness questions and questions about how participants interact with others.\n\nRegardless of the program, the training includes 8 one-on-one sessions with a trained staff member over the course of about 1 month. Each session will last approximately 60-90 minutes. These sessions will start shortly after completing the first assessment. Preferably, participants will complete 1-2 training sessions a week, depending on availability and preference. These sessions will include education, discussion, and practice exercises.\n\nAfter the program is finished, participants will be asked to complete the same surveys completed at baseline for three follow-up time points (immediately following the program, 3 months after the program, and 6 months after). Total participation in the study will last approximately 8 months.",[54],"Traumatic Brain Injury",[56,57,58],"Emotional Health Training","Severe Traumatic Brain Injury","Moderate Traumatic Brain Injury","RECRUITING","2026-06-19",{"date":62,"type":34},"2026-06-23",{"date":64,"type":34},"2026-06-10",{"date":66,"type":19},"2028-05-31",{"name":40,"class":41},1,{"id":70,"slug":4,"hasResults":10,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":20,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":4},"100591998","NCT06987708","Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers","Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers Associated With Monoclonal Gammopathy of Unknown Significance (MGUS) and Smoldering Myeloma (SM): A Prospective Intervention Pilot Study","Inclusion Criteria:\n\n* Adults 18 years or older.\n* Diagnosed with MGUS or SM based on commonly accepted criteria per the\n\nInternational Multiple Myeloma Working Group (IMWG), defined as follows:\n\na. For a diagnosis of Smoldering Multiple Myeloma (SM), both criteria must be met: i. Serum monoclonal protein (IgG or IgA) ≥ 30g\u002FL or urinary monoclonal protein ≥ 500mg per 24h and\u002For clonal bone marrow plasma cells 10-60% ii. Absence of myeloma-defining events or amyloidosis b. For a diagnosis of Non-IgM Monoclonal Gammopathy of Undetermined\n\nSignificance (MGUS):\n\ni. Serum monoclonal protein \\\u003C30g\u002FL ii. Clonal bone marrow plasma cells \\\u003C10% iii. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder c. For a diagnosis of IgM MGUS: i. Serum IgM monoclonal protein \\\u003C30g\u002FL ii. No evidence of anemia, constitutional symptoms, hyperviscosity, lymphadenopathy, hepatosplenomegaly, or other end-organ damage that can be attributed to the plasma cell proliferative disorder d. For a diagnosis of light change MGUS: i. Abnormal FLC ratio (\\\u003C0.26 or \\>1.65) ii. Increased level of the appropriate free light chain (increased κ FLC in patients with ratio \\>1.65 and increased λ FLC in patients with ratio \\\u003C0.26) iii. No immunoglobulin heavy chain expression on immunofixation iv. Absence of end-organ damage such as hypercalcemia, renal insufficiency, anemia, and bone lesions (CRAB) or amyloidosis that can be attributed to the plasma cell proliferative disorder v. Clonal bone marrow plasma cells \\\u003C10% vi. Urinary monoclonal protein \\\u003C500mg\u002F24h\n\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2\n* Ability to speak, read and comprehend the English language.\n* Absence of significant intercurrent illness such as uncontrolled heart failure, unstable angina, cardiac arrhythmia and psychiatric illness which would preclude informed consent.\n* Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol.\n* Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.\n\nExclusion Criteria:\n\n* Evidence of any one or more of the following biomarkers of malignancy, or myeloma-defining events (MDEs) meeting IMWG criteria for a diagnosis of multiple myeloma:\n\n  1. 60% or greater clonal plasma cells on bone marrow examination\n  2. Serum involved \u002F uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved light chain is at least 100mg\u002FL (a patient's involved free light chain either kappa or lambda is the one that is above the normal reference range; the uninvolved free light chain is the one that is typically in, or below, the normal range)\n  3. More than one focal lesion on MRI that is at least 5mm or greater in size.\n* Evidence of end-organ damage as per the IMWG CRAB criteria, defined as follows:\n\n  1. Hypercalcemia: serum calcium \\>0.25 mmol\u002FL (\\>1mg\u002FdL) higher than the upper limit of normal or \\>2.75 mmol\u002FL (\\>11mg\u002FdL)\n  2. Renal insufficiency: creatinine clearance \\\u003C40 mL per minute or serum creatinine \\>177mol\u002FL (\\>2mg\u002FdL)\n  3. Anemia: hemoglobin value of \\>20g\u002FL below the lowest limit of normal, or a hemoglobin value \\\u003C100g\u002FL\n  4. Bone lesions: one or more osteolytic lesions on skeletal radiography, CT, or PET\u002FCT. If bone marrow has \\\u003C10% clonal plasma cells, more than one bone lesion is required to distinguish from solitary plasmacytoma with minimal marrow involvement\n* Unwillingness or inability to follow required intervention behaviors, including any safety issues related to participating in any part of the intervention (e.g., a contraindication to gentle movement\u002Fexercise, BMI \\\u003C18 kg\u002Fm2, etc.).\n* Pregnancy or breastfeeding\n* Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.",{"count":76,"type":19},67,[22],"A prospective, pilot study to assess the impact of a 12-month multi-focal lifestyle intervention on myeloma-relevant biomarkers in patients with MGUS or SM. The multimodal lifestyle intervention has six foci that patients will participate in over the course of one-year.",[80,81],"Monoclonal Gammopathy of Uncertain Significance","Smoldering Myeloma","2026-06-12",{"date":84,"type":34},"2026-06-15",{"date":86,"type":19},"2026-07-01",{"date":88,"type":19},"2028-07-01",{"name":40,"class":41},{"id":91,"slug":4,"hasResults":10,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":20,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100626524","NCT07436754","Clinical Trial Comparing the Efficacy of Two Teletherapy Programs at Improving Psychological Health in People With Brain Injury","Clinical Trial to Evaluate the Efficacy of Building Emotional Self-awareness Teletherapy (BEST) at Improving Psychological Health in Service Members With Brain Injury","Inclusion Criteria:\n\n* Mild TBI\n* ≥18 years old\n* ≥6 months post-TBI\n* Elevated alexithymia and emotion dysregulation\n* Capacity to consent\n* Speaks and understands English\n* Personal device capable of video conferencing and internet\n\nExclusion Criteria:\n\n* Premorbid neurological disorder other than TBI\n* Degenerative neurologic condition\n* Active or uncontrolled major psychiatric disorder\n* Conditions that pose safety concern to self or others, such as suicide risk\n* Previous psychiatric hospitalization\n* Visual, hearing, communication, or cognitive impairments that would impede participation\n* Unstable medications (e.g., started \\\u003C 6 weeks prior to enrollment) or anticipated medication changes that will influence mood\u002F affect during study participation\n* Active involvement in an intensive rehabilitation program\n* Individuals who recently started psychotherapy and\u002For mental health counseling (e.g., \\\u003C3 months prior)",{"count":97,"type":19},300,[22],"The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.",[101,102],"Mild Traumatic Brain Injury","Alexithymia",[104,105,106,107,108],"Emotional dysregulation","Brain training","Concussion","Veterans","Military service members","2026-06-11",{"date":82,"type":34},{"date":112,"type":34},"2026-05-20",{"date":114,"type":19},"2031-03",{"name":40,"class":41},3,{"id":118,"slug":4,"hasResults":10,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":20,"phases":128,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":68},"100332538","NCT03609580","Post-operative Urinary Retention (POUR) Following Thoracic Surgery","POUR","Inclusion Criteria:\n\nMales\n\n≥50 years old Planned surgical procedure of a minimally invasive thoracic surgical procedure (wedge resection, segmentectomy, lobectomy, pleural biopsy, or pleurodesis) Surgery scheduled more than 3 days from the time of consent\n\nExclusion Criteria:\n\n* Using Flomax already\n* Allergy to Flomax or sulfa drugs\n* Current use of alpha blockers or alpha agonists\n* Resting systolic blood pressure \\\u003C100\n* Orthostatic hypotension of \\>20mm Hg (millimeters of mercury) Systolic and\u002For 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent\n* Known diagnosis of congestive heart failure and valvular heart disease\n* History of prostate surgery (prostatectomy, trans-urethral resection)",true,"MALE","50 Years",{"count":127,"type":19},127,[129,130],"PHASE1","PHASE2","Inability to urinate a common complication that happens to many patients after a surgery, especially in men over 60 years of age who undergo surgery on their chest. Urinary retention is uncomfortable, increases anxiety, increases hospital length of stay, and leads to more procedures such as putting in a bladder catheter (Foley). This is uncomfortable, and can lead to bleeding, infection, damage to the urethra and\u002For bladder and bladder spasm. The goal of this study is to attempt to prevent inability to urinate by giving patients a medication called Flomax (Tamusolin) every day beginning a week before surgery. That medication relaxes the prostate. It's approved by the Food and Drug Administration (FDA) to improve urinary flow in those with enlarged prostates. It is also commonly used in patients with bladder problems due to inability to urinate who have required a Foley.",[133],"Urinary Retention",[135,136,137,138,139,140,141],"post operative urinary retention","inability to urinate","urinary retentions","lung cancer","VATs","Robotic Lung Surgery","lung resections","2026-06-09",{"date":109,"type":34},{"date":145,"type":34},"2018-05-07",{"date":147,"type":19},"2027-03-30",{"name":40,"class":41},{"id":150,"slug":4,"hasResults":10,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":10,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":154,"targetDuration":156,"studyType":157,"phases":4,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":68},"100423502","NCT04794686","ETMR One: An International Registry and Research Platform for Children With Embryonal Tumor With Multilayer Rosettes","Inclusion Criteria:\n\n1. Patients of any age\n2. Patients must have either a histologically confirmed primary intracranial CNS Embryonal Tumor with Multilayer Rosettes (as agreed upon by central review or local pathologist OR\n3. Patients must have tumor tissue that possesses C19MC amplification . Central Review is not required (but is strongly recommended) if the patient's tumor does not demonstrate C19MC amplification.\n4. Patients may be enrolled at point following diagnosis",{"count":155,"type":19},100,"10 Years","OBSERVATIONAL","This research is being done to find out more information about a brain tumor called Embryonal Tumor with Multilayer Rosettes (ETMR) by collecting medical information from children who have this disease.\n\nThe purpose of this research study is to create and maintain a research database for patients with ETMR. The database will include information about occurrence rates, patient information, tumor tissue information, and response to treatment. This will help advance our understanding of this rare disease.\n\nIn addition, this study will include obtaining survival data and evaluating therapeutic response to expert consensus therapy, and procuring patient tumor tissue.",[160],"Embryonal Tumor With Multilayered Rosettes",[162,163,164],"Embryonal","Multilayer Rosettes","CNS tumor","2026-05-29",{"date":167,"type":34},"2026-06-02",{"date":169,"type":34},"2020-07-12",{"date":171,"type":19},"2030-07-12",{"name":40,"class":41},{"id":174,"slug":4,"hasResults":10,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":20,"phases":182,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":68},"100640935","NCT07621796","Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant","Efficacy and Safety of Tenecteplase Among acutE Ischemic Stroke Patients With Recent Ingestion of Direct Oral Anticoagulant (ESTER-DOAC)","ESTER-DOAC","Inclusion Criteria:\n\n* Adults (18 years or older) with a suspected acute ischemic stroke and clearly disabling deficits\n* Presenting within 4.5 hours of last known well\n* Able to initiate intravenous thrombolysis within 4.5 hours of last known well\n* On recent DOAC therapy (dabigatran, apixaban, rivaroxaban, edoxaban) and known last dose taken within 48 hours from thrombolysis.\n\nExclusion Criteria:\n\n* Current or history of intracerebral hemorrhage\n* Non-disabling deficits\n* Bleeding disorder (e.g. hemophilia) or advanced liver disease or known INR \\> 1.7 within 6 hours\n* Use of therapeutic low molecular weight heparin or therapeutic dose heparin with elevated PTT\n* ASPECTS \\\u003C 6 or clear hypodensity on CT suggestive of completed infarct\n* Advanced kidney disease (eGFR \\\u003C 30 ml\u002Fmin)\n* Known or suspected aortic dissection\n* Known or high suspicion for infective endocarditis\n* Surgery within 2 weeks\n* Intracranial or intraspinal surgery within 3 months\n* Active internal bleeding or gastrointestinal or urinary tract hemorrhage within 3 weeks\n* Intracranial neoplasm, arterio-venous malformation, or cavernous malformation\n* Major head trauma or ischemic stroke within 3 months\n* Known thrombocytopenia (platelets \\\u003C 100,000)\n* Planned endovascular treatment within 30 minutes of study drug administration (i.e., consent, randomization and administration of study drug must occur at least 30 minutes prior to groin puncture; standard care is not to be delayed and patients in whom endovascular therapy will start sooner will not be enrolled)\n* Comorbid condition with life expectancy of less than 3 months\n* Any condition that precludes thrombolytic therapy as determined by site principal investigator\n* Pregnancy",{"count":181,"type":19},660,[183],"PHASE3","The study will randomize patients with acute ischemic stroke and Direct Oral AntiCoagulants (DOAC) ingestion within 48 hours from enrollment (but otherwise eligible for thrombolysis) to administration of intravenous tenecteplase vs. placebo (1:1).\n\nParticipants will be enrolled at NIH StrokeNet sites across the US and followed for 90-days.\n\nThe primary aim is to determine the efficacy of intravenous tenecteplase (TNK) vs placebo among acute ischemic stroke patients and to determine the safety of TNK among acute ischemic stroke patients within 4.5 hours of last known well who used DOAC within 48 hours prior to thrombolysis. Efficacy and safety endpoints will be the focus of this proposed Phase III study.",[186],"Acute Ischemic Stroke",[188,189,190,191],"acute ischemic stroke","Oral AntiCoagulants","thrombolysis","intravenous tenecteplase administration","2026-05-26",{"date":167,"type":34},{"date":195,"type":19},"2027-01-01",{"date":197,"type":19},"2032-01-30",{"name":40,"class":41},{"id":200,"slug":4,"hasResults":10,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":123,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":204,"targetDuration":156,"studyType":157,"phases":4,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":68},"100577907","NCT06804395","CanScan; Community-based Registry to Assess, Address and advaNce SCreening for cANcer Prevention and Management","* Adults ( 18 and older)\n* Ability to provide own consent\n* Must meet at least one of the below criteria, Indicating an increased risk for cancer, any of the following:\n\n  * Family or personal history suggests a familial\u002Fhereditary disorder known or suspected of predisposition to cancer.\n  * Personal factors associated with an increased risk for cancer include benign breast disease, polyps, tobacco use, etc.as defined by the investigator.\n  * Family members of participating individuals.\n* Any participant in the HICAP program regardless of cancer risk",{"count":205,"type":19},10000,"Early diagnosis of cancer allows for better treatment outcomes, higher survival rates, and lower costs of care. It is shown that cancer monitoring for cancer in at-risk populations is a key component in early diagnosis. The HMH Hennessey Institute for Cancer prevention and Applied Molecular Science (HICAP) is a newly founded institute, providing clinical services for cancer screening and risk assessment to the community, as well as research in cancer risk and prevention. The CanScan registry will prospectively collect data from participants in the form of questionnaires. The registry will also capture data that is collected as per non-research assessments, for participants who consent to participate. The registry will facilitate better understanding of cancer risk, screening, and diagnostics.",[208],"Cancer Risk",[210,208,211,212],"Cancer Prevention","Cancer Early Detection","Cancer High Risk","2026-05-21",{"date":192,"type":34},{"date":216,"type":34},"2024-10-01",{"date":218,"type":19},"2034-10-01",{"name":40,"class":41},{"id":221,"slug":4,"hasResults":10,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":10,"sex":15,"minAge":226,"maxAge":227,"enrollmentInfo":228,"targetDuration":4,"studyType":20,"phases":229,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":241,"leadSponsor":243,"locationsCount":68},"100626979","NCT07442669","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration","Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration: A Pilot Study","Inclusion Criteria:\n\n* Inborn at 27 0\u002F7 to 34 6\u002F7 weeks of gestational age\n* Spontaneously breathing at birth but requiring non-invasive respiratory support\n* RDS diagnosed on chest x-ray (diffuse, bilateral, fine granular opacities in lungs, air bronchograms) or were at risk of developing RDS\n\nExclusion Criteria:\n\n* Outborn\n* Endotracheal intubation in the delivery room or within 2 hours of life\n* Surfactant in the delivery room as part of advanced resuscitation\n* Presence of major congenital malformations or chromosomal anomalies\n* Hydrops fetalis\n* Inherited disorders of metabolism\n* Air leak syndrome (pneumothorax, pneumomediastinum) prior to surfactant administration, congenital diaphragmatic hernia, congenital pneumonia, meconium aspiration syndrome\n* Infants in extremis not expected to survive","27 Weeks","34 Weeks",{"count":155,"type":19},[22],"This prospective randomized controlled study aims to determine if using a lung ultrasound score can lead to a faster diagnosis of severe respiratory distress syndrome and quicker administration of surfactant in moderately and late-preterm infants. The research will involve 100 infants, with 67 in the prospective group and 33 serving as controls.\n\nThe primary goal is to shorten the time to treatment for these vulnerable newborns. The study will also assess whether this ultrasound-guided approach improves short-term respiratory outcomes. These secondary objectives include measuring any decrease in the need for and duration of mechanical ventilation, the length of non-invasive respiratory support, and the overall need for oxygen.\n\nThe study population includes infants born between 27 and 34 6\u002F7 weeks of gestation who are admitted to the NICU. Each participant will be monitored from birth until they are discharged or transferred. This research aligns with a growing body of evidence suggesting that lung ultrasound can be a valuable tool in neonatal care, potentially leading to earlier and more precise treatment for respiratory distress syndrome.",[232,233],"Respiratory Distress Syndrome, Newborn","Respiratory Distress Syndrome in Premature Infant",[235,236,237],"Respiratory Distress","Lung ultrasound","Surfactant Administration",{"date":239,"type":34},"2026-05-22",{"date":86,"type":19},{"date":242,"type":19},"2028-07-05",{"name":40,"class":41},{"id":245,"slug":4,"hasResults":10,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":10,"sex":15,"minAge":227,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":157,"phases":4,"briefSummary":251,"conditions":252,"keywords":256,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":68},"100609551","NCT07216053","Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates","Inclusion Criteria:\n\n* Inborn infants born between 34w0d and 36w6d gestational age\n* In RA or 1 Litre per minute 1LPM NC (room air (RA) or nasal cannula (NC))\n* Admitted to NICU or Well Baby Nursery (WBN)\n\nExclusion Criteria:\n\n* Patients born \\\u003C34 weeks or \\>36w6d\n* Major genetic anomaly or syndromic condition\n* Cardiac or pulmonary structural defects\n* Cord pH \\\u003C7.0 or 5 minute APGAR 5 or less\n* Suspected fetal hemorrhage or other source of significant anemia at birth","36 Weeks",{"count":97,"type":19},"Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate.\n\nWith this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.",[253,254,255],"Pre-Term","Respiratory Distress of Newborn","Premature",[257,258,259,260],"Lung Ultrasound","Respiratory Decompensation","Late Preterm Neonates","respiratory distress",{"date":239,"type":34},{"date":263,"type":34},"2025-11-06",{"date":265,"type":19},"2027-11",{"name":40,"class":41},{"id":268,"slug":4,"hasResults":10,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":273,"enrollmentInfo":274,"targetDuration":4,"studyType":20,"phases":276,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":68},"100498953","NCT05776953","Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients","Evaluation of the Effects of Ketorolac 15mg IV Versus 30mg IV on Duration of Analgesia in Patients Who Present to the Emergency Department With Renal Colic","Inclusion Criteria:\n\nPatients will be included if they present to the Emergency Department with (all of the following):\n\n* Adult emergency department patients \\\u003C 65 years old\n* One or more of the following common ED chief complaints associated with the suspected diagnosis of renal colic. These chief complaints include but are not limited to: flank pain, back pain, abdominal pain, left and\u002For right lower quadrant pain, and\u002For pelvic pain\n* Pain score of 4 or greater on the 0-10 NRS\n* Determination of treatment with IV ketorolac\n\nExclusion Criteria:\n\nPatients will be excluded if any of the following apply:\n\n* Allergy to ketorolac\n* Pregnant patients\n* Previously received analgesic medications within 4 hours prior to administration of ketorolac in our ED\n* Known or stated history of renal insufficiency\n* Body weight \\\u003C 50 kg\n* Age greater than 65 years\n* Patients that do no read\u002Fwrite Spanish or English","65 Years",{"count":275,"type":19},86,[277],"PHASE4","This is a prospective interventional study examining the effect of ketorolac at doses of 15mg versus 30 mg for duration of analgesia in emergency department patients with suspected renal colic.",[280,281,282,283],"Renal Colic","Flank Pain","Emergencies","Analgesia",{"date":239,"type":34},{"date":286,"type":34},"2023-12-21",{"date":288,"type":19},"2026-09-01",{"name":40,"class":41},{"id":291,"slug":4,"hasResults":10,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":10,"sex":15,"minAge":296,"maxAge":297,"enrollmentInfo":298,"targetDuration":4,"studyType":20,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":318},"100495069","NCT05726383","Iscador® P (Mistletoe) Immunotherapy for Recurrent Resectable Osteogenic Sarcoma","MISTOSUS: Iscador® P (Mistletoe) Immunotherapy To Improve Event Free Survival In Patients With Relapsed Resectable Osteosarcoma","Inclusion Criteria:\n\n* Histologic diagnosis of osteosarcoma.\n* Patients with at least one episode of relapse in the lung (without limitation of number of episodes), following surgical resection of all gross metastatic disease.\n* Surgical resection of all possible sites of suspected pulmonary metastases in order to achieve a complete remission within 8 weeks prior to study enrollment. Note: If surgery related changes such as atelectasis are seen on the post-operative CT scan, patients will remain eligible to enroll as long as the operating surgeon believes that all sites of metastases were resected. Patients with positive microscopic margins will be eligible to enroll.\n* Pathological confirmation of metastases from at least one of the resected sites.\n* Age ≥ 8 years of age and \\\u003C30 years of age.\n* Patients must be able to receive subcutaneous injections.\n* Performance level as measured by Karnofsky ≥60% for patients \\> 16 years of age or Lansky ≥ 60% for patients ≤ 16 years of age.\n* Female patients of childbearing potential must have a negative serum blood pregnancy test during screening and a negative urine pregnancy test within 3 days prior to receiving the first dose of study drug. If the screening serum test is done within 3 days prior to receiving the first dose of study drug, a urine test is not required. If a patient is of childbearing potential the patient must agree to use effective contraception during the study and for 120 days after the last dose of study drug.\n* If male, agrees to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug\n* Life expectancy of \\> two months\n* Experienced resolution of toxic effect(s) of the most recent prior anti-cancer therapy to Grade \\\u003C1 (except alopecia, cytopenia, or neuropathy). If a patient underwent major surgery or radiation therapy of \\>30 Gy, they must have recovered from the toxicity and\u002For complications from the intervention.\n* Patients must meet the following laboratory criteria\n\n  1. Adequate hepatic function with serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal (ULN) and total serum bilirubin \\\u003C 2.5 times the ULN or Direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 2.5 X ULN\n  2. Absolute neutrophil count ≥ 500\u002FdL\n  3. Platelet count ≥ 20,000\u002FL\n  4. Creatinine ≤ 1.5 X the ULN or measurement of calculated creatinine clearance (CrCl) ≥ 60 ml\u002Fminute\n\nExclusion Criteria:\n\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator, including, but not limited to:\n\n  * Another known malignancy other than osteosarcoma that is progressing or requires active treatment.\n  * Any prior history of other cancer within the prior 5 years with the exception of adequately treated basal cell carcinoma or cervical intraepithelial neoplasia \\[CIN\\]\u002Fcervical carcinoma in situ or melanoma in situ).\n  * Active infection requiring systemic therapy.\n  * Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n  * New recurrence of osteosarcoma metastasis in any location other than lung\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of study drug.\n* Known history of human immunodeficiency virus (HIV) (HIV 1\u002F2 antibodies).\n* Known active hepatitis B (e.g., hepatitis B surface antigen-reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid \\[qualitative\\]). Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBc Ab\\] and absence of HBsAg) are eligible. HBV DNA test must be performed in these patients prior to study treatment. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.\n* Known history of chronic granulomatous diseases, florid autoimmune diseases, diseases treated with immunosuppressive drugs, hyperthyroidism with tachycardia, tuberculosis, parasitosis or Crohn's disease.\n* If female, is pregnant or breastfeeding.\n* Patients must have had no systemic chemotherapy or immunotherapy in the three weeks prior to enrollment and must have fully recovered from side effects of prior treatment at enrollment.\n* Patients may not receive any additional chemotherapeutic agent (either conventional or experimental) while on study.\n* Patients must not have received radiation therapy for up to two weeks prior to enrollment.\n* Patients must have no known prior allergy to Iscador® P or any other Viscum album products.\n* Patients must not receive concomitant treatment with immunostimulant or immunosuppressive drugs.","8 Years","30 Years",{"count":299,"type":19},32,[130],"This will be a phase II, single arm study of osteosarcoma patients with fully resected pulmonary metastases. The MTD corresponds to the dosage recommendations of the manufacturer of Iscador® P which is licensed in Sweden, New Zealand, South Korea, Germany and Switzerland for the treatment of solid tumors and precancerous lesions.\n\nThe study population includes patients with relapse of osteosarcoma in the lung following surgical resection of all gross disease (2nd or greater CR). Following completion of final thoracotomy, they will be treated with Iscador® P at concentrations up to the MTD with surveillance imaging via CT scan to monitor for relapsed disease.",[303],"Osteogenic Sarcoma Recurrent",[305,306,307,308,309,310,311],"Osteogenic","Sarcoma","Pulmonary","Metastatic","Immunotherapy","Mistletoe","Bone Tumor",{"date":239,"type":34},{"date":314,"type":34},"2024-05-14",{"date":316,"type":19},"2027-05-11",{"name":40,"class":41},2,{"id":320,"slug":4,"hasResults":10,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":123,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":20,"phases":327,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":4},"100640270","NCT07594782","ED Medicaid Support","Maintaining Continuous Medicaid Coverage for Eligible Children in New Jersey","Inclusion Criteria:\n\n* Parent\u002Fguardian\u002F legal authorized representative (age 18 years or older) with children aged: 1 month to 17 years of age who obtain care in the pediatric emergency department\n* Child Uninsured (ie, Charity Care, HUMC Charity Care, Pending Medicaid, Self-Pay)\n* Interested in applying or receiving assistance with NJfamilycare\n* Not pending private insurance coverage\n* Primary language of the parent or guardian is identified as English\n* Pediatric patient lives in New Jersey\n\nExclusion Criteria:\n\n* Parent\u002Fguardian\u002Flegal authorized representative with children aged: less than 1 month and greater than 17 years old Insured pediatric patient Parent\u002F Guardian\u002FLegal Authorized Representative not present Parent\u002F Guardian\u002FLegal Authorized Representative age 17 years or younger Primary language not identified as English Patients visiting the Emergency Department related to Motor Vehicle Accidents Already participated in this study",{"count":326,"type":19},180,[22],"The study introduces a bedside intervention assisting families with the enrollment or re-enrollment process through patient direct contact with NJFamily Care and financial departments, using an emergency department (ED)-based navigator tool. The primary objective is to identify the barriers contributing to the lack of insurance coverage through NJ Family Care coverage using a brief survey with the parents of children who are treated in the ED and identified as uninsured, and to study the effect of a bedside intervention designed to assist families with the enrollment or re-enrollment process.",[330,282],"Pediatric Uninsured Emergency Visits",[332,333,334,335],"Pediatric uninsured emergency visits","lack of insurance","linkage to resources","Medicaid","2026-05-11",{"date":338,"type":34},"2026-05-19",{"date":340,"type":19},"2026-05-15",{"date":342,"type":19},"2028-05-15",{"name":40,"class":41},{"id":345,"slug":4,"hasResults":10,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":273,"enrollmentInfo":350,"targetDuration":4,"studyType":20,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":116},"100609446","NCT07214688","Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies","A Phase 2 Study of Fludarabine and Intermediate-dose Total Body Irradiation (800 cGy) Followed by Post-transplant Cyclophosphamide in Patients Aged 18-65 Undergoing Allogeneic Stem Cell Transplant for Hematologic Malignancies","Inclusion Criteria:\n\n* Patients ages 18-65 years.\n* Patients with a diagnosis of one of the following hematologic malignancies:\n* Acute myeloid leukemia or chronic myeloid leukemia with no circulating blasts and less than 5% blasts in the bone marrow;\n* Myelodysplastic syndrome with less than 5% blasts in the bone marrow by IHC or flow cytometry whichever is highest;\n* Myeloproliferative neoplasms with less than 5% blast in the marrow and peripheral blood;\n* Acute lymphoblastic leukemia in CR (CIBMTR criteria); or Lymphoma in CR (CIBMTR criteria).\n* Patients who are eligible for allogeneic stem cell transplant per Transplant Program SOPs.\n* Patients with a Karnofsky performance status (KPS) of ≥60%.\n* Patients with adequate organ function defined by:\n\n  * Cardiac: LVEF ≥50%\n  * Pulmonary: DLCO ≥50% of predicted\n  * Hepatic: Bilirubin ≤1.5x ULN, ALT\u002FAST ≤2.5x ULN\n  * Renal: Creatinine clearance ≥50 mL\u002Fmin\n* All participants of reproductive potential must use effective contraception following allogeneic hematopoietic stem cell transplantation (allo-HSCT), in accordance with guidelines from the American Society for Transplantation and Cellular Therapy (ASTCT), the FDA, and other expert bodies.\n* For Male Participants:\n\n  ○ Male participants must use effective contraception for at least 12 months after transplant, and longer if receiving immunosuppressive or cytotoxic medications. Chemotherapy and radiation can cause DNA damage to sperm, and even if fertility returns, mutations may persist for months. In cases where drugs such as mycophenolate mofetil (MMF) or lenalidomide are used, FDA guidance requires contraception for at least 90 days after discontinuation. Sperm cryopreservation should be offered prior to conditioning. Participants must avoid fathering a child during this time frame.15-17\n* For Female Participants:\n\n  * Female participants of childbearing potential are required to use highly effective contraception for a minimum of 12 to 24 months post-transplant, or longer if still receiving immunosuppressive or teratogenic therapy. For drugs such as MMF, sirolimus, or ruxolitinib, contraception must continue for 3 months after the last dose.\n  * A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.15-17\n* Patients with a suitable donor for allogeneic stem cell transplant defined by:\n\n  * Matched sibling donors willing to donate mobilized peripheral blood (PBSC) or bone marrow (BM), meeting all institutional criteria for donation;\n  * Unrelated donors at \\>7\u002F8 (i.e., mismatched at only one of the HLA-A, HLA-B, HLA-C, and HLA-DRB1 loci) willing to donate mobilized PBSC or BM, and medically eligible to donate cells according to National Marrow Donor Program criteria; or Related Haploidentical donors willing to donate PBSC or BM and meeting criteria for donation.\n* Patients who are able to comply with follow-up visits and treatment plans.\n* Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n* Hematopoietic cell transplantation comorbidity index above 3.\n* Patients with a Karnofsky performance status (KPS) of \\\u003C60%.\n* Patients with active infections or other contraindications for allogeneic stem cell transplant.\n* Patients who are unable or unwilling to give informed consent.\n* Patients who have received a prior allogeneic transplant.\n* Patients who are unable to comply with follow-up visits and treatment plans.",{"count":351,"type":19},209,[130],"The Flu-TBI 800 trial is a prospective, single-arm, multicenter, interventional phase 2 study to evaluate whether fludarabine plus intermediate-dose total body irradiation (TBI 800 cGy) with post-transplant cyclophosphamide (PTCy) (experimental regimen) improves the 1-year survival of allogeneic stem cell transplant recipients.",[355],"Allogeneic Stem Cell Transplant Recipient","2026-03-20",{"date":358,"type":34},"2026-03-23",{"date":360,"type":34},"2026-01-06",{"date":362,"type":19},"2032-01",{"name":40,"class":41},{"id":365,"slug":4,"hasResults":10,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":10,"sex":124,"minAge":16,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":20,"phases":372,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":378,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":68},"100593815","NCT07011342","Utility of 18F-rhPSMA-7.3 in the Diagnosis of Prostate Cancer After Focal Gland Treatment","SCOUT","Inclusion Criteria:\n\n* Adult males 18 years or older;\n* Patient must have a pre-treatment MRI;\n* Patient underwent SOC focal therapy with either focal or hemiablation for the treatment of intermediate risk prostate cancer in the past 9 months prior to enrollment;\n* Intermediate risk disease as defined by American Urology Academy (AUA)\u002FNational Comprehensive Cancer Network (NCCN) guidelines (see Appendix A)\n* Life Expectancy of 10 years or more;\n* Underwent standard template biopsy before treatment with a minimum of 2 cores into the MRI visible lesion if lesion was present;\n* Patient understands the purpose of the trial and procedures required for the trial, and can provide signed informed consent as which includes compliances with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol; and\n* Ability to adhere to the study visit schedule and all the protocol requirements, including surveillance imaging and test specimen (blood sample) collection at specified time points.\n\nExclusion Criteria:\n\n* Patients under the age of 18 will be considered pediatric patients and will not be included in this study because they are thought to represent a unique population outside the scope of this study as it is aimed at identifying factors that affect adults only.\n* Patients previously treated with whole gland ablation or prior partial gland ablation over 9 months prior to enrollment.",{"count":371,"type":19},70,[22],"To evaluate the effectiveness of a PSMA-PET scan in identifying recurrent prostate cancer after focal therapy",[375],"Prostate Cancer",[377],"PSMA-PET",{"date":358,"type":34},{"date":380,"type":34},"2025-10-01",{"date":382,"type":19},"2028-11",{"name":40,"class":41},{"id":385,"slug":4,"hasResults":10,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":10,"sex":124,"minAge":16,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":20,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":396,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":116},"100577458","NCT06798558","Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy","Phase II Study of Neoadjuvant Lu-177-PSMA-617 in Patients With High Risk Localized Prostate Cancer Undergoing Radical Prostatectomy","Inclusion Criteria:\n\n* Patients age 18 or older.\n* Patients with histologically confirmed adenocarcinoma of the prostate.\n* Patients with high-risk disease defined as a preoperative prostate biopsy of Gleason Score 8 (GS8) (Grade group 4 \\[GG4\\]) or higher. Men with evidence of lymph node involvement at or below the bifurcation of the common iliac arteries (cN1) on PET-CT 68Ga-PSMA-11 are eligible.\n* Pre-operative, pre-treatment PSMA scan with high expression in prostate confirmed by PET\u002FCT 68Ga-PSMA-11 (greater than liver). Patients must not have any other PET FDG-positive sites outside the prostate.\n* Patients who are able and willing to undergo surgery.\n* Patients with a life expectancy of greater than 10 years. Life expectancy can be estimated using any 1 of the following tools:\n\n  * The Social Security Administration tables:\n\nhttps:\u002F\u002Fwww.ssa.gov\u002FOACT\u002FSTATS\u002Ftable4c6.html\n\n* The WHO's Life Tables by country:\n\nhttps:\u002F\u002Fapps.who.int\u002Fgho\u002Fdata\u002Fview.main.60000?lang=en\n\n* The Memorial Sloan Kettering Male Life Expectancy tool:\n\nhttps:\u002F\u002Fwww.mskcc.org\u002Fnomograms\u002Fprostate\n\n* If using a life expectancy table, life expectancy should be adjusted using the clinician's assessment of overall health as follows: best quartile of health - add 50%; worst quartile of health - subtract 50%; and middle two quartiles of health - no adjustment. See the NCCN Prostate Cancer Guidelines for more information.\n\n  * Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n  * Patients who agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agree to refrain from donating sperm, as defined below:\n* With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\< 1% per year during the treatment period and for 14 weeks after the final dose of study treatment. Men must refrain from donating sperm during this same period.\n* With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 14 weeks after the final dose of study treatment to avoid potential exposure to the embryo.\n* The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n\n  * Patients who are able to comply with follow-up visits and treatment plans.\n  * Patients who are able to give informed consent.\n\nExclusion Criteria:\n\n* Patients with a prior history of prostate cancer treatment.\n* Patients with previous treatment with PSMA-targeted radioligand therapy or any of the following within 6 months of enrollment confirmation: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.\n* Patients with distant disease (outside of local lymph nodes).\n* Significant bone marrow impairment defined by leukocytes \\<3,000\u002FmcL, absolute neutrophil count (ANC) \\<1,500\u002FmcL, and platelet count lower than 70,000\u002FmcL.\n* Significant liver function impairment defined by total bilirubin higher than 1.5 times the upper limit of normal (ULN), andASL\u002FALT higher than 3 times the ULN.\n* Impaired kidney function defined by glomerular filtration rate (GFR) lower than 40 mL\u002Fmin, or concomitant use of nephrotoxic drugs. Kidney function based on eGFR by Modification of Diet in Renal Disease (MDRD) equation:\n\n  * Normal renal function: participants with eGFR 90 mL\u002Fmin\n  * Moderate renal impairment: participants with eGFR 30 to 59 mL\u002Fmin\n  * Severe renal impairment: participants with eGFR 15 to 29 mL\u002Fmin\n* Patients with significant comorbidities that would make them poor candidates for surgery.\n* Patients with evidence of metastatic disease (enlarged lymph nodes, distant metastatic sites, visceral or bone metastases, etc.).\n* Patients with a history of radiation or hormone therapy to the prostate.\n* Patients with a history of bleeding disorders or who are taking anticoagulant therapy.\n* Patients with active infections or other contraindications for surgery.\n* Patients who are unable or unwilling to give informed consent.\n* Patients who are unable to comply with follow-up visits and treatment plans",{"count":391,"type":19},54,[130],"Male adults with a confirmed diagnosis of prostate adenocarcinoma who meet criteria for localized high risk prostate cancer according to the NCCN guidelines and who are eligible for prostatectomy will be invited to participate. Criteria for high-risk prostate cancer include patients with preoperative prostate biopsy score of Gleason 8 (GS8) (Grade group 4 \\[GG4\\]) or higher. Patients also need to have a positive PSMA scan on 68-Ga-PSMA-11 PET\u002FCT scan.",[395],"Prostate Adenocarcinoma",{"date":358,"type":34},{"date":398,"type":34},"2025-03-05",{"date":400,"type":19},"2029-03",{"name":40,"class":41},{"id":403,"slug":4,"hasResults":10,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":20,"phases":411,"briefSummary":412,"conditions":413,"keywords":415,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":68},"100531420","NCT06199570","Support for Cancer Patients Awaiting News","Support for Cancer Patients Awaiting News (SCAN Study): Pilot Testing a Stress Management Program","SCAN","Inclusion Criteria:\n\n1. Adult (ages 18 and older)\n2. Comfortable speaking, reading, and writing English without an interpreter\n3. Established diagnosis of lung cancer (3a. Open Trial phase only: Stage III-IV lung cancer or extensive stage small cell lung cancer)\n4. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 2\n5. Receiving ongoing care from collaborating clinics with regular scans\n6. Receiving systemic treatment for lung cancer\n7. Endorse appointment- or scan-related stress on 4-item screen (using a modified Distress Thermometer item, a Fear of Progression scale item, an Impact of Events scale item, and an item from our prior study)\n8. Willingness to use the study website\n\nExclusion Criteria:\n\n1. Moderate-to-severe cognitive impairment (per dementia diagnosis or cognitive screen)\n2. Requires an interpreter for medical visits\n3. Severe psychiatric illness (psychiatric hospitalization in the past year, or substance use disorder, bipolar disorder, or psychosis diagnosis)\n4. Currently enrolled in hospice\n5. Unable to complete study activities per oncology provider's judgment (e.g., due to fatigue)",{"count":410,"type":19},60,[22],"This is a behavioral trial study to pilot test a stress management intervention for people with cancer who are undergoing routine cancer scans. The study will involve two pilot testing phases. Initial feasibility will be determined in an Open Trial phase, to inform any needed revisions to the intervention and\u002For protocol prior to a Pilot Randomized Controlled Trial phase. The Open Trial phase is an unblinded, single-site, single-arm open trial (n=10). The Pilot randomized clinical trial (RCT) phase is an unblinded, single-site, feasibility pilot randomized controlled trial (n=50).",[414],"Lung Cancer",[416,417,418,419,138],"Stress management","Cancer related anxiety","Scan related anxiety","Advanced lung cancer","2026-02-17",{"date":422,"type":34},"2026-02-19",{"date":424,"type":34},"2024-05-01",{"date":426,"type":19},"2026-12-30",{"name":40,"class":41},{"id":429,"slug":4,"hasResults":10,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":20,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":116},"100494211","NCT05715229","Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy","A Multicenter Phase II Randomized Trial Of Immunotherapy Versus Chemotherapy Guided By Circulating Tumor DNA-Based Molecular Response On Patients With Metastatic NSCLC","G360-IIT","Inclusion Criteria:\n\n1. Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC\n2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.\n3. Patients will require a baseline Guardant360 CDx test prior to enrollment\n4. Patients willing to undergo serial ctDNA testing as required by protocol\n5. Patients will be over the age of 18\n6. Life expectancy ≥12 weeks\n7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.\n8. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization\n9. ECOG Performance Score ≤2\n10. Adequate organ function\n11. Hemoglobin \\> 9 g\u002FdL\n12. Platelets \\> 100,000mm3 or 100 x 109\u002FL\n13. AST, ALT \\\u003C 2.5 x ULN with no liver metastases or \\\u003C 5x ULN with the presence of liver metastases\n14. Total bilirubin \\\u003C 1.5 x ULN if no liver metastases or \\\u003C 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n15. Absolute neutrophil count (ANC) \\> 1500 cells\u002Fmm3\n16. Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin calculated by Cockcroft and Gault's equation\n17. Willing to use highly effective contraceptive measures if child-bearing potential or if the patient's sexual partner is a woman of childbearing potential: a. Female subjects should be using a highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to starting of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: i. Post-menopausal is defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not a tubal ligation b. Male subjects should be willing to use barrier contraception\n\nExclusion Criteria:\n\n1. Patients under the age of 18\n2. Inability to provide informed consent by either the patient or the authorized representative\n3. Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)\n4. Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline\n5. Subjects with untreated CNS metastases are excluded.\n6. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.\n7. Subjects with carcinomatous meningitis\n8. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization\n9. Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical\u002Fdysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be needed during the study period.\n10. Other active malignancy requiring concurrent intervention.\n11. Subjects with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n12. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroids \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n13. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n14. Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:\n\n    1. Uncontrolled hypertension, which is defined as systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg despite optimal medical management.\n    2. Active coronary artery disease, including unstable all newly diagnosed angina within 3 months of study enrollment.\n    3. Myocardial infarction in the past 6 months.\n    4. History of congenital long QT syndrome.\n    5. History of clinically significant arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.\n    6. Uncontrolled heart failure, defined as class III of 4 by the New York Heart Association functional classification.\n    7. History of a current diagnosis of myocarditis.\n15. the Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.\n16. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n17. Subjects with Grade 2 peripheral neuropathy\n18. Life expectancy \\\u003C12 weeks",{"count":436,"type":19},108,[130],"This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.",[440],"Carcinoma, Non-Small-Cell Lung",[442,443,444,445],"Advanced Non Small Cell Lung Cancer (NSCLC)","Metastatic NSCLC","circulating tumor DNA (ctDNA)","G360",{"date":447,"type":34},"2026-02-18",{"date":449,"type":34},"2023-09-29",{"date":451,"type":19},"2027-04-28",{"name":40,"class":41},{"id":454,"slug":4,"hasResults":10,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":20,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":465,"startDateStruct":466,"completionDateStruct":468,"leadSponsor":470,"locationsCount":318},"100454574","NCT05199311","Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Transplant Eligible Multiple Myeloma","A Phase I\u002FII Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma","Inclusion Criteria:\n\n1. Documented newly diagnosed multiple myeloma\n\n   a. At least 25% of patients accrued should be high risk as defined by IMWG or mSMART criteria.\n2. Patient should be deemed transplant eligible.\n3. Patients may not have had more than 1 cycle of prior induction therapy. If a patient has had 1 cycle of prior multiple myeloma therapy, the patient must have had documented measurable disease prior to initiation of cycle 1.\n4. Subjects must satisfy the following criteria to be enrolled in the study:\n\n   1. Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n   2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments\u002Fprocedures being conducted.\n   3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.\n5. Subjects must have a documented diagnosis of MM and have measurable disease defined as:\n\n   1. M-protein (serum and\u002For urine protein electrophoresis (sPEP or uPEP)): sPEP≥0.5 g\u002FdL or uPEP ≥ 200 mg\u002F24 hours and\u002For\n   2. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg\u002FdL (100 mg\u002FL) and abnormal serum immunoglobulin kappa lambda free light chain ratio\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.\n7. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral salpingectomy, or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) and must:\n\n   a. Have two negative pregnancy tests as verified by the Investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.\n8. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with two forms of contraception: one highly effective, and one additional effective (barrier) measure of contraception without interruption 28 days prior to starting investigational product, during the study treatment (including dose interruptions), and for at least 28 days after the last dose of iberdomide.\n9. Male subjects must:\n\n   a. Male subjects must practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \\[e.g. calendar, ovulation, symptothermal or post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.) or agree to use a condom during sexual contact with a pregnant female or a FCBP while taking iberdomide, during dose interruptions and for at least 28 days following the last dose of iberdomide even he has undergone a successful vasectomy.\n10. Males must agree to refrain from donating sperm while on study treatment, during dose interruptions and for at least 28 days following last dose of study treatment.\n11. All subjects must agree to refrain from donating blood while on study treatment, during dose interruptions and for at least 28 days following the last dose of study treatment.\n12. All male and female subjects must follow all requirements defined in the Pregnancy Prevention Program.\n\nNote: A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\nExclusion Criteria:\n\n1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study\n2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n3. Subject has any condition that confounds the ability to interpret data from the study\n4. Subject has nonsecretory multiple myeloma\n5. Subjects with Plasma Cell leukemia or amyloidosis (with the exception of isolated marrow involvement).\n6. Any of the following laboratory abnormalities:\n\n   1. Absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL\n   2. Platelet count \\\u003C 50,000\u002FμL. It is not permissible to transfuse subjects to achieve minimum platelet counts.\n   3. Corrected serum calcium \\> 13.5 mg\u002FdL (\\> 3.4 mmol\u002FL)\n   4. Serum glutamic oxaloacetic transaminase (SGOT)\u002Faspartate aminotransferase (AST) or serum glutamic pyruvic transaminase (SGPT)\u002Falanine aminotransferase (ALT) ≥ 2.5 x upper limit of normal (ULN)\n   5. Serum total bilirubin, direct bilirubin, or alkaline phosphatase ≥ 1.5 x ULN\n   6. Subjects with serious renal impairment (\\[CrCl\\] \\\u003C 30 mL\u002Fmin) or requiring dialysis would be excluded\n7. Subjects with peripheral neuropathy ≥ Grade 2\n8. Subjects with gastrointestinal disease that may significantly alter the absorption of iberdomide\n9. Subjects with a prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 3 years with the exception of the following noninvasive malignancies:\n\n   1. Basal cell carcinoma of the skin\n   2. Squamous cell carcinoma of the skin\n   3. Carcinoma in situ of the cervix\n   4. Carcinoma in situ of the breast\n   5. Incidental histological findings of prostate cancer such as T1a or T1b using the Tumor\u002FNode\u002FMetastasis (TNM) classification of malignant tumors or prostate cancer that is curative\n10. Subject has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide\n11. Contraindications to the other treatment regimens, as per local prescribing information\n12. Subject has received any of the following within the last 14 days of initiating IP:\n\n    1. Plasmapheresis\n    2. Major surgery (as defined by the Investigator)\n    3. Radiation therapy other than local therapy for MM associated bone lesions\n    4. Use of any systemic myeloma drug therapy\n13. Subject has been treated with an investigational agent (ie, an agent not commercially available) within 28 days or 5 half-lives (whichever is longer) of initiating IP\n14. Subject has any one of the following:\n\n    1. Active congestive heart failure (New York Heart Association Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected QT interval (QTc) of \\> 470 msec, pericardial disease, or myocardial infarction within 4 months prior to randomization.\n    2. Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris\n    3. Subject experienced a cardiac event within 6 months prior to the first dose of IP\n15. Subject has current or prior use of immunosuppressive medication within 14 days prior to the first dose of IP. The following are exceptions to this criterion:\n\n    1. Intranasal, inhaled, topical or local steroid injections (eg, intra-articular injection)\n    2. Glucocorticoid therapy within 14 days prior to randomization that exceeds a cumulative dose of 160 mg of dexamethasone or equivalent dose of other corticosteroids.\n    3. Steroids as premedication for hypersensitivity reactions (eg, computed tomography \\[CT\\] scan premedication)\n16. Subject has taken a strong inhibitor or inducer of CYP3A4\u002F5 including grapefruit, St. John's Wort or related products within two weeks prior to dosing and during the course of study\n17. Subject known to test positive for human immunodeficiency virus (HIV), uncontrolled or active viral hepatitis.\n18. Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis\n19. Subject is a female who is pregnant, nursing or breastfeeding, or who intends to become pregnant during the participation in the study, or who will not agree to comply with contraceptive requirements or pregnancy monitoring requirements\n20. Left ventricular ejection fraction (LVEF) \\\u003C 40% as determined by echocardiogram (ECHO)\n21. Prior use of iberdomide\n22. Subject is pregnant\n23. Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment. Uncontrolled hypertension is defined as: a subject whose blood pressure exceeds ≥ 160 mmHg systolic or ≥ 100 mmHg diastolic when taken in accordance with the European Society of Hypertension\u002FEuropean Society of Cardiology 2018 guidelines",{"count":460,"type":19},66,[129,130],"This is a multi-institution, open label, phase I\u002FII study of Iberdomide, Carfilzomib, and dexamethasone (KID) in patients with newly diagnosed transplant eligible MM.",[464],"Multiple Myeloma",{"date":447,"type":34},{"date":467,"type":34},"2022-05-13",{"date":469,"type":19},"2026-06",{"name":40,"class":41},{"id":472,"slug":4,"hasResults":10,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":476,"eligibilityCriteria":477,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":20,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":68},"100355550","NCT03909412","Carfilzomib Based Chemotherapy Mobilization for Autologous Stem Cell Transplants in Multiple Myeloma","Phase I Study of Carfilzomib-based Chemotherapy Mobilization for Autologous Stem Cell Transplantation in Multiple Myeloma","CarMob","INCLUSION CRITERIA Subject has voluntarily agreed to participate by giving written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Informed Consent must be obtained prior to mobilization.\n\n* Subject has a confirmed diagnosis of multiple myeloma as specified by the International Myeloma Working Group criteria and must have measurable disease as defined by at least one of the following criteria:\n* Serum monoclonal protein ≥ 0.5 g\u002FdL\n* ≥200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n* Serum immunoglobulin free light chain: involved FLC ≥ 10 mg\u002FdL (≥ 100 mg\u002FL) AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* MRD positivity in peripheral blood by flow cytometry.\n* Subject previously received treatment with Carfilzomib.\n* Subject is ≥18 years of age at the time of signing the informed consent form.\n* Subject has an ECOG performance status of \\\u003C 2.\n* Subjects must have completed any \"induction therapy\" and have achieved less than a CR.\n* Subject has a life expectancy of \\>12 weeks.\n\n  * Absolute neutrophil count (ANC) ≥1000 cells\u002Fmm3 (≥500 for patients with bone marrow biopsy displaying \\>50% involvement by myeloma)\n  * Platelets count ≥ 50,000\u002Fmm3 (≥ 30,000 for patients with bone marrow biopsy displaying \\>50% involvement by myeloma)\n  * Hemoglobin \\> 9.0 g\u002FdL\n  * Serum SGOT\u002FAST \\\u003C3.0 x upper limits of normal (ULN)\n  * Serum SGPT\u002FALT \\\u003C3.0 x upper limits of normal (ULN)\n  * Serum total bilirubin \\\u003C1.5 x ULN\n* Subject must have a MUGA scan or echo with LVEF ≥40% within 6 months of enrollment.\n* Females of childbearing potential (FCBP) must have a negative serum pregnancy test should be done within 7 days of treatment initiation and a negative urine pregnancy test within the 24 hours prior to the first study drug administration\n* FCBP and male subjects who are sexually active with FCBP must agree to use 2 highly effective concomitant methods of contraception including a male condom during the study and for 90 days following the last dose of study treatment\n* Male subjects must agree to not donate sperm while taking carfilzomib and for 90 days after the last dose of carfilzomib.\n\nEXCLUSION CRITERIA\n\n* Subject has a history of allergic reactions to compounds containing captisol, or Carfilzomib\n* Subject has a NYHA Class III or IV heart disease and\u002For a history of active unstable angina, congestive heart disease, severe uncontrolled cardiac arrhythmia, electrocardiographic evidence of acute ischemia, active conduction system abnormalities or myocardial infarction within 6 months prior to enrollment. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.\n* Uncontrolled hypertension.\n* Pulmonary hypertension.\n* Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (subjects with hepatitis B surface antigen or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study).\n* Subject has active viral or bacterial infections or any coexisting medical problem that would significantly increase the risks of this treatment program.\n* Subject has concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place him\u002Fher at unacceptable risk, including, but not limited to, uncontrolled hypertension, uncontrolled diabetes, active uncontrolled infection, and\u002For acute chronic liver disease (i.e., hepatitis, cirrhosis).\n* Subject has ≥Grade 2 peripheral neuropathy.\n* Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.\n* Subject has received radiation therapy within 3 weeks of enrollment. Enrollment of subjects who require concurrent radiotherapy (which must be localized in its field size) should be deferred until the radiotherapy is completed and 3 weeks have elapsed since the last date of therapy.\n* Subject has had prior mobilization or stem cell transplant.",{"count":479,"type":19},18,[129],"This phase I study utilizes a 3+3 design with escalating cohorts of Carfilzomib at 20mg\u002Fm2, 27mg\u002Fm2, 36mg\u002Fm2, 45mg\u002Fm2, 56mg\u002Fm2, and 70mg\u002Fm2 to be administered concomitantly with Cyclophosphamide 2 gm\u002Fm2, Dexamethasone and Granulocyte colony-stimulating factor (G-CSF)",[464],{"date":447,"type":34},{"date":485,"type":34},"2019-10-08",{"date":487,"type":19},"2026-09",{"name":40,"class":41},{"id":490,"slug":4,"hasResults":10,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":4,"eligibilityCriteria":494,"healthyVolunteers":10,"sex":495,"minAge":16,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":20,"phases":498,"briefSummary":499,"conditions":500,"keywords":502,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":68},"100592264","NCT06991166","OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression","OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers","Inclusion Criteria:\n\n* Mother of NICU infant\n* Older than age 18\n* English-speaking\n* Gave birth more than 24 hours ago and less than 12 months prior to enrollment\n* Depression as assessed by:\n\nCurrent\u002FPrior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of \"sometimes\" or \"often\" on item #10 on the EPDS\\* (\"I have had thoughts of harming myself\")\n\nExclusion Criteria:\n\n* A diagnosis of Substance Dependency or Substance Use\n* Acute suicidal or infanticidal ideation\n* Current psychosis\n* Medical history of cognitive impairment\n* Infant death of current NICU admission\n* Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),\n* Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)","FEMALE",{"count":497,"type":19},72,[22],"Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than \"baby blues\". PPD differs greatly from \"baby blues\", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.\n\nOne-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.\n\nThis clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.",[501],"Post Partum Depression",[501,503,504,505,506],"Cognitive behavioral therapy","interpersonal therapy","psychotherapy","NICU","2026-02-09",{"date":509,"type":34},"2026-02-11",{"date":511,"type":34},"2025-09-15",{"date":513,"type":19},"2027-09-01",{"name":40,"class":41},{"id":516,"slug":4,"hasResults":10,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":521,"enrollmentInfo":522,"targetDuration":4,"studyType":20,"phases":524,"briefSummary":525,"conditions":526,"keywords":528,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":533,"startDateStruct":534,"completionDateStruct":536,"leadSponsor":538,"locationsCount":68},"100588164","NCT06937827","Transitions of Care Clinic (TOCC)","Impact of Multidisciplinary Transitions of Care Clinic on Readmission Rates for Patients With Heart Failure With Preserved Ejection Fraction at a University Medical Center","Inclusion Criteria:\n\n* Adults ages 18 to 90 years old discharged from Ocean University Medical Center (OUMC)\n* Inpatient admission for heart failure with preserved ejection fraction (HFpEF) exacerbation\n* Patient discharged home with or without homecare\n\nExclusion Criteria:\n\n* Refuse to participate in TOCC phone calls\n* Discharged to a facility\n* Discharged with homecare services\n* Discharged on hospice services\n* Hemodialysis\n* Leave against medical advice (AMA)\n* Pregnant\n* Diagnosed with dementia\n* Without medical capacity or unable to provide own consent","90 Years",{"count":523,"type":19},150,[22],"The transition period from hospital to home is a time of heightened risk for patients to experience adverse events, medication errors, and readmission to the hospital. Patients at the highest risk include older adults and patients with low health literacy, socioeconomic disadvantages, and\u002For multiple comorbidities. This project proposes to expand the existing Transitions of Care Clinic (TOCC) which was recently introduced in our institution in 2024, to bridge the gap in care between hospital discharge to home and connect discharged patients to their outpatient providers with a focus on patients with heart failure (HF).\n\nThe existing TOCC, a multidisciplinary team composed of a pharmacist and a nurse practitioner, seeks to improve the services that are currently being provided to patients and enhance the transitions of care process by providing patients with education, tools, and resources to help manage their chronic disease. With this study, we propose to expand TOCC by offering extensive education to patients via iPad videos and providing them with HF tool kits prior to their discharge. We will also assist with scheduling follow appointments with their outpatient providers and follow up with patients after the appointment takes place to re-evaluate their needs and reinforce self management of heart failure.\n\nBy targeting patients being treated for acute exacerbation of heart failure with preserved ejection fraction (HFpEF), this study aims to facilitate the transition of care, reduce hospital readmissions and improve patients' quality of life and satisfaction. Patients with HFpEF represent a majority of the HF patients that are readmitted at OUMC. HFpEF patients have fewer guideline recommended treatments and represent a vulnerable patient population. The HF tool kits will provide these patients with the essential tools, resources, and log sheets for self-management such as monitoring daily weights, monitoring blood pressure and heart rate. Patients provided with a kit will receive an initial phone call from TOCC within 1 to 3 days of discharge and a second phone call within 21-24-days post discharge.",[527],"Heart Failure With Preserved Ejection Fraction",[529,530,531,532],"Discharge plans","heart failure with preserved ejection fraction","Readmissions","transition of care",{"date":509,"type":34},{"date":535,"type":34},"2025-06-26",{"date":537,"type":19},"2027-04-15",{"name":40,"class":41},{"id":540,"slug":4,"hasResults":10,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":10,"sex":15,"minAge":125,"maxAge":545,"enrollmentInfo":546,"targetDuration":4,"studyType":20,"phases":547,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":556,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":563},"100562620","NCT06605534","Leveraging the Emergency Department (LEAD) Study","LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities","Inclusion Criteria:\n\n* Aged 50 years to 80 years\n* Currently smoke cigarettes or quit smoking cigarettes within the past 15 years\n* 20 pack-year smoking history\n* Has never had lung cancer screening\n* Able to provide informed consent\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Diagnosed with lung cancer\n* Has a history of having a lung cancer screening scan\n* Unable to speak and understand English","80 Years",{"count":155,"type":19},[22],"This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.",[414],[551,138,552,553,554],"screening","Disparities","social determinants of health","emergency department","2026-02-06",{"date":557,"type":34},"2026-02-10",{"date":559,"type":34},"2024-10-29",{"date":561,"type":19},"2026-10-30",{"name":40,"class":41},10,{"id":565,"slug":4,"hasResults":10,"nctId":566,"briefTitle":567,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":10,"sex":124,"minAge":569,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":20,"phases":572,"briefSummary":574,"conditions":575,"keywords":576,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":555,"lastUpdatePostDateStruct":585,"startDateStruct":586,"completionDateStruct":588,"leadSponsor":590,"locationsCount":591},"100489812","NCT05657990","Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery","Inclusion Criteria:\n\n* Males\n* ≥55 years old\n* Planned thoracic oncological surgical procedure of a video assisted oncological surgical procedure for suspected or confirmed cancer.\n* Surgery scheduled more than 7 days from the time of consent\n\nExclusion Criteria:\n\n* Using Tamsulosin already\n* Known allergy to Tamsulosin or sulfa drugs\n* Current use of Boceprevir\n* Resting systolic blood pressure \\\u003C100\n* Orthostatic hypotension of \\>20mm Hg systolic and\u002For 10mm Hg diastolic pressure from sitting to standing (after 2 minutes of standing) as measured at the time of consent\n* Known history of hypotension\n* Known diagnosis of congestive heart failure (CHF) and valvular heart disease\n* History of prior prostate surgery (prostatectomy, trans-urethral resection)","55 Years",{"count":571,"type":19},46,[573],"EARLY_PHASE1","This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.",[133],[133,577,578,579,580,581,582,583,584],"post surgery Urinary Retention","thoracic surgery","spontaneous voiding","bladder retention","Tamsulosin (FlomaxTM)","kidney injury","men undergoing thoracic oncological surgical procedure","BladderScanner",{"date":557,"type":34},{"date":587,"type":34},"2023-04-03",{"date":589,"type":19},"2026-12",{"name":40,"class":41},4,{"id":593,"slug":4,"hasResults":10,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":597,"eligibilityCriteria":598,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":20,"phases":600,"briefSummary":601,"conditions":602,"keywords":605,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":68},"100489348","NCT05651945","Cardiac Rehabilitation of Stroke Survivors (SRP-CROSS)","Stroke Recovery Program-Cardiac Rehabilitation of Stroke Survivors","SRP-CROSS","Inclusion Criteria:\n\n* 18 years or older\n* Stroke diagnosis (ischemic or hemorrhagic) \u002F radiologic evidence of acute stroke\n* Medically cleared by a cardiologist for participation in the cardiac rehabilitation program with no contraindications to cardiac rehabilitation per American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines\n* Ability to transfer on\u002Foff the recumbent bike with or without an assistive device safely, with or without assistance from another person\n* Ability to follow simple commands and communicate pain or distress\n* Admission to an Inpatient Rehabilitation Facility post-stroke\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Presence of subarachnoid hemorrhage, intracranial aneurysm, intracranial hemangioma, or arteriovenous malformation\n* Medical disorders that preclude participation in the study as determined by the Principal Investigator.\n* Inability to have baseline assessment within 60 days post-stroke diagnosis\n* Patient considered unable to comply with study requirements\n* Known terminal illness with life expectancy less than 1 year\n* Compliant diagnosis eligible for traditional cardiac rehabilitation covered by insurance\n* Unable to understand\u002Fspeak English",{"count":523,"type":19},[22],"This study examines the effectiveness of the cardiac rehabilitation program for stroke patients. The study will examine if patients with stroke, who receive cardiac rehabilitation in addition to their standard of care treatments, demonstrate improved recovery of function. It will also examine if these patients have reduced hospital readmission, reduced rate of recurrent stroke, and mortality.",[603,604],"Stroke","Cerebrovascular Accident",[606,607,608,609,610,611,612,613,614,615,616],"cardiac rehabilitation","stroke","stroke rehabilitation","stroke recovery","exercise","cardiovascular disease","cardiovascular function","cognitive function","physical function","neurorehabilitation","transition of care post stroke","2026-02-03",{"date":619,"type":34},"2026-02-05",{"date":621,"type":34},"2023-01-20",{"date":623,"type":19},"2031-01-20",{"name":40,"class":41},""]