[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Methodist Hospital Research Institute\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":598},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,49,75,101,128,149,171,192,210,234,258,279,302,323,345,370,392,412,439,461,479,500,529,551,575],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100642024","phase-1-interleukine-2-il-2-plus-semaglutide-in-alzheimers-disease-100642024",false,"NCT07651319","Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease","A Phase Ib Clinical Trial, Using Interleukin-2 (IL-2) and Semaglutide in Patients With Alzheimer's Disease","Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.\n* Male or female age 50 to 86 years\n* MMSE between 16-26\n* Albumin greater than or equal to 3.0mg\u002FdL\n* White Blood Count (WBC) \\>3,500\u002Fmm3; platelets \\>100,000\u002Fmm3; hematocrit (HCT) \\>32%.\n* INR\\\u003C1.4\n* If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study.\n* English language speaking\n* Formal education of eight or more years\n* Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening\n* A family member or caretaker who is expected to be consistently available, administer study drugs of IL-2 and attend study visits throughout the study.\n* For AD patients with limited decision-making capacity, the legally authorized representative (LAR) should be present and consent based on the patient's best interest.\n\nExclusion Criteria:\n\n* Any untreated bacterial, fungal or viral infection\n* Renal dysfunction indicated by serum creatinine greater than 1.5 mg\u002FdL\n* Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal\n* Clinically significant pulmonary dysfunction, including a history of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease \\[COPD\\]) associated with functional limitation, or FEV₁ \\\u003C 75% of predicted for age and height when pulmonary function testing indicated to evaluate ongoing respiratory symptoms\n* Clinically significant cardiac dysfunction, including a history of uncontrolled cardiac arrhythmias, prior cardiac tamponade, or unstable angina or myocardial infarction within 3 months prior to screening, or clinically significant abnormalities on baseline electrocardiogram (ECG). LVEF\\\u003C 40% in echocardiography if clinically indicated based on ongoing cardiac symptoms or abnormal ECG findings\n* Hypersensitivity or allergy to IL-2\n* History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening.\n* History of hemorrhage or infarct or \\> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.\n* Clinical or laboratory findings consistent with:\n\n  1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)\n  2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)\n  3. Seizure disorder\n  4. History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)\n  5. Clinically significant abnormal T4 or TSH\n* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:\n\n  1. Respiratory insufficiency\n  2. Bradycardia (\\\u003C45\u002Fmin.) or tachycardia (\\>100\u002Fmin.)\n  3. Poorly managed hypertension (systolic \\>160 mm Hg and\u002For diastolic \\>95 mm Hg) or hypotension (systolic \\\u003C90 mm Hg and\u002For diastolic \\\u003C60 mm Hg)\n  4. Uncontrolled diabetes defined by HbA1c \\>8%\n* History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.\n* History of acute\u002Fchronic hepatitis B or C and\u002For carriers of hepatitis B\n* History of organ allografts\n* Current treatment with insulin or insulin secretagogues (including sulfonylureas or meglitinides)\n* Prior GLP-1 RA administration or natural GLP1 supplements intake within the past 6 months\n* Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty, etc.).\n* Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg\u002Fday, quetiapine ≤100 mg\u002Fday, olanzapine ≤5 mg\u002Fday, and aripiprazole ≤10 mg\u002Fday), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests.\n* Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.\n* Use of concomitant CYP-metabolized medications with a narrow therapeutic index including warfarin, calcineurin inhibitors, or theophylline)\n* Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening\n* Suspected or known allergy to any components of the study treatments.\n* Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.\n* Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR \\>1.4 or other coagulopathy; platelet count of \\\u003C100,000\u002FμL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.\n* Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.","ALL","50 Years","86 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited. Growing evidence suggests that inflammation in the brain and the body plays a key role in the onset and progression of AD. In particular, immune cells called regulatory T cells (Tregs), which normally help control inflammation, are impaired in AD individuals. This leads to increased activity of harmful immune pathways that worsen brain injury. Interleukin-2 (IL-2) is a drug that can restore the function of Tregs. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, are a class of drugs currently used to treat diabetes and obesity. Beyond their metabolic effects, GLP-1RAs also reduce inflammation, protect brain cells, and improve cellular energy balance. Laboratory studies, including our own, show that combining IL-2 with semaglutide has stronger effects than either drug alone. Together, they enhance Treg function, dampen harmful inflammatory responses, and improve cell survival. These findings support testing IL-2 plus semaglutide as a novel combination therapy for AD. We now propose a clinical trial to evaluate the safety, feasibility, and biological effects of this strategy. The study will enroll 30 individuals with AD, ages 50 to 86, who have a confirmed diagnosis by amyloid PET brain imaging and a Mini-Mental State Exam score between 16 and 26. Participants will be randomly assigned to one of three groups: (1) placebo, (2) low-dose IL-2 alone, or (3) IL-2 combined with semaglutide. Throughout the trial, participants will undergo regular medical exams, blood tests, and safety monitoring. We will measure how the treatment affects Tregs and other immune cells, inflammatory markers in blood and CSF, and established Alzheimer's biomarkers such as amyloid beta, tau, and neurofilament light chain. Cognitive and functional assessments will also be conducted to explore potential benefits on memory and daily living skills. If successful, this study will provide the first evidence that a dual immunotherapeutic strategy can safely modify disease-related processes in AD. Such findings would lay the foundation for larger clinical trials and could open the door to a new, multimodal approach to slowing or preventing Alzheimer's progression.",[29],"Alzheimer Dementia (AD)",[31,32,33,34,35],"Alzheimer's Disease","inflammation","Immunotherapy","IL-2","Semaglutide","RECRUITING","2026-06-10",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":22},"2026-07",{"date":44,"type":22},"2029-12",{"name":46,"class":47},"The Methodist Hospital Research Institute","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100643250","vr-based-cognitive-stimulation-games-for-delirium-prevention-100643250","NCT07641153","VR-Based Cognitive Stimulation Games for Delirium Prevention","Virtual Reality-Based Cognitive Stimulation Games for Enhancing Attention and Preventing Delirium in Older Surgical Patients With Cognitive Impairment","Inclusion Criteria:\n\n* Men and women ≥65 years of age\n* Have a pre-existing diagnosis of cognitive impairment (Montreal Cognitive Assessment Score of 15-24)\n* Elective or emergency major surgery with the expectation of admission to the Intensive Care Unit following the surgery for three days following surgery\n\nExclusion Criteria:\n\n* Pre-existing Intubation and invasive ventilation;\n* history of severe mental illness;\n* admission for a drug overdose;\n* severe vertigo;\n* history of severe postoperative nausea and vomiting;\n* hearing and visual impairment;\n* preexisting severe dementia (Montreal Cognitive Assessment Score \\\u003C 15; and\n* active delirium at the time of screening for eligibility criteria.\n* Active suicidal ideation or behavior Screen failure after surgery\n* Prolonged intubation after surgery (more than 24 hours)","65 Years",{"count":58,"type":22},90,[60],"NA","This trial aims to evaluate the feasibility, safety, and acceptability of a virtual reality (VR)-based cognitive stimulation game to reduce postoperative delirium among older surgical patients at high risk due to pre-existing cognitive impairment.",[63,64,65],"Surgery","Delirium - Postoperative","Delirium","2026-06-08",{"date":68,"type":40},"2026-06-11",{"date":70,"type":40},"2026-04-24",{"date":72,"type":22},"2029-05-01",{"name":46,"class":47},2,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100489973","phase-2-alpelisibinos-inhibitornab-paclitaxel-in-patients-with-her2-negative-metaplastic-breast-cancer-mpbc-100489973","NCT05660083","Alpelisib\u002FiNOS Inhibitor\u002FNab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)","Phase II Trial of Alpelisib With iNOS Inhibitor and Nab-paclitaxel in Patients With HER2 Negative Metastatic or Locally Advanced Metaplastic Breast Cancer (MpBC)","Inclusion Criteria:\n\n1. The patient (or legally acceptable representative if applicable) provides written informed consent for the study.\n2. At least 18 years of age on the day of informed consent signing.\n3. Histologically confirmed HER2 negative MpBC and\u002For Triple Negative Breast Cancer (TNBC) with squamous and\u002For sarcomatoid elements, including osseous, chondroid, and spindle morphology.\n4. HER2 negative status as defined by the current American Society of Clinical Oncology and College of American Pathologists guidelines at time of study entry.\n5. Locally advanced inoperable or metastatic MpBC with measurable disease by RECIST 1.1 Both first- and second-line patients will be eligible for this trial. Patients may have received prior immunotherapy, per standard of care.\n6. Eastern Cooperative Oncology Group performance status of 0 or 1.\n7. Adequate organ and marrow function as defined below:\n\n   * Hemoglobin ≥9.0 g\u002Fdl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Absolute neutrophil count ≥1000\u002FμL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n   * Platelet count ≥100,000\u002FμL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n   * Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB \\[\\>1.5 x ULN\\] is allowed),\n   * Aspartate transaminase\u002Falanine transaminase ≤5 x institutional ULN\n   * Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL\u002Fmin\u002F1.\n8. Fasting blood glucose of ≤140 mg\u002Fdl and HgbA1c ≤7.0.\n9. Ability to swallow oral medication.\n10. Ability to take aspirin.\n11. Women of childbearing potential must agree to use contraception for the duration of the study through 90 days after the last dose of study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm during the study and up to the time period as specified in labels of study drugs.\n12. If patient received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting the study treatment.\n13. Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n1. Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. The patient must have discontinued strong CYP3A4 inhibitors or strong CYP3A4 inducers for at least 1 week prior to study treatment initiation (Examples included in Appendix 2).\n2. Currently receiving warfarin or other coumarin-derived anticoagulant for treatment, prophylaxis, or otherwise. Therapy with DOACs, heparin, low molecular weight heparin, direct oral anticoagulants or fondaparinux is allowed.\n3. Concurrent use of medications that interact with nitrate\u002Fnitrite levels (Examples included in Appendix 3).\n4. Received previous treatment with nab-paclitaxel, Pl3K inhibitor, AKT inhibitor, or mTOR inhibitor.\n5. Known history of Steven Johnson's syndrome or toxic epidermal necrolysis.\n6. Since HAART agents are metabolized by CYP3A4, HIV positive patients will be excluded from this trial.\n7. Poorly controlled hypertension at baseline (defined as systolic blood pressure \\>150 mm Hg). Isolated, unconfirmed systolic BP elevations will NOT exclude participation. Patients with medication-controlled hypertension are allowed provided they have been on their current medications for at least 4 weeks prior to Cycle 1, Day 1.\n8. Has any of the following cardiac abnormalities:\n\n   * Symptomatic congestive heart failure\n   * History of documented congestive heart failure (New York Heart Association functional classification III-IV)\n   * Documented cardiomyopathy\n   * Left ventricular ejection fraction \\\u003C50% as determined by multigated acquisition scan or echocardiogram\n   * Myocardial infarction \\~6 months prior to enrollment\n   * Unstable angina pectoris\n   * Serious uncontrolled cardiac arrhythmia\n   * Symptomatic pericarditis\n   * History of congenital QT prolongation\n   * Absolute corrected QT interval of \\>480 msec in the presence of potassium \\>4.0 mEq\u002FL and magnesium \\>1.8 mg\u002Fdl.\n9. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 3 weeks prior to study treatment administration. NOTE: Patients who have entered the follow-up phase of an investigational study may participate as long as it has been 3 weeks after the last dose of the previous investigational agent.\n10. Known or suspected hypersensitivity to any component or excipient of the proposed regimen (nab-paclitaxel, alpelisib, iNOS inhibitor, aspirin).\n11. Known additional malignancy that requires active treatment.\n12. Pneumonitis\u002F interstitial lung disease on baseline CT scan of the chest or moderate to severe chronic lung disease\n13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n14. Manifestations of malabsorption due to prior gastrointestinal surgery, gastrointestinal surgery disease, or an unknown reason.\n15. Symptomatic\u002Funtreated metastatic central nervous system disease.\n16. Type I diabetes mellitus irrespective of Hgb A1c OR uncontrolled type II diabetes mellitus defined as hemoglobin A1c \\>7%.\n17. Uncontrolled gastric ulcer\n18. ≥ Grade 2 sensory neuropathy\n19. Osteonecrosis of jaw\n20. Pancreatitis\n21. Pregnant, breastfeeding or expecting to conceive children within the projected duration of the study, starting with the prescreening or screening visit through 30 days after the last dose of study treatment.","18 Years",{"count":84,"type":22},36,[26],"This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments.\n\nParticipants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle) until disease progression, toxicity or until the participant withdraws from the study. The nab-paclitaxel chemotherapy will be administered intravenously on Day 1 of the 3 week cycles. Participants will take the drug alpelisib by mouth once daily at a dose determined by a safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week cycles.",[88,89,90,91],"HER2-negative Breast Cancer","Metastatic Breast Cancer","Metaplastic Breast Carcinoma","TNBC - Triple-Negative Breast Cancer","2026-06-03",{"date":94,"type":40},"2026-06-04",{"date":96,"type":40},"2023-01-12",{"date":98,"type":22},"2028-12-02",{"name":46,"class":47},3,{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":48},"100587615","phase-1-dexamethasone-for-ureteral-stent-symptoms-dusts-100587615","NCT06930690","Dexamethasone for Ureteral STent Symptoms (DUSTS)","Dexamethasone for Ureteral STent Symptoms (DUSTS): A Randomized, Double-blinded Controlled Study","DUSTS","Inclusion Criteria:\n\n1. Age 18-70 years old\n2. Patients who are undergoing unilateral retrograde ureteroscopy (semi-rigid or flexible) with planned ureteral stent placement for treatment of renal\u002Fureteral stones\n3. Patients who can read and understand English\n4. Patients who can follow up post-operatively within 7 days at Houston Methodist Hospital\n\nExclusion Criteria:\n\n1. Untreated UTI\n2. HbA1c ≥6.5 on preoperative testing\n3. Patients with prior diagnosis of any type of diabetes mellitus\n4. Patients with immunosuppression, including chronic corticosteroid use\n5. Patients with bleeding disorder\n6. Patients with chronic liver disease, cirrhosis, and liver failure.\n7. Patients taking strong CYP3A4 inducers or inhibitors within two weeks of screening\n8. Chronic opioid analgesic use\n9. Congenital renal abnormalities (e.g. pelvic kidney, ureteric duplication) that may impair stent placement\n10. Concurrent genitourinary malignancy\n11. Urinary diversion\n12. Renal transplantation\n13. History of interstitial cystitis\u002Fpainful bladder syndrome, prostatitis, pelvic pain due to other conditions (e.g. endometriosis)\n14. Neurologic disorder (e.g. spinal cord injury, multiple sclerosis, spina bifida)\n15. Pregnant or breastfeeding\n16. Patients with cognitive impairments or untreated psychiatric illness","70 Years",{"count":111,"type":22},70,[25,26],"The purpose of this study to learn if high-dose dexamethasone, a type of long-acting steroid, works to decrease urinary symptoms and pain after ureteroscopy and stent placement for kidney stones. The main question it aims to answer is:\n\n1\\) Does high-dose steroid change the quality of life score on day 2 after surgery\n\nResearchers will compare high-dose of dexamethasone (20 mg) to a standard dose of dexamethasone (4 mg) to see if a higher dose of the drug will help with urinary symptoms and pain\n\nParticipants will:\n\n1. randomly receive 20 mg or 4 mg of dexamethasone (20 mg) at the time of surgery\n2. fill out a questionnaire day 1 and day 2 after surgery\n3. fill out a medication diary for one week after surgery\n4. visit the clinic on day 2 after surgery for checkup\n5. visit the clinic on day 4-7 after surgery for check up",[115],"Ureteral Stent-Related Symptom",[117,118,119,115],"Ureteral Stent","Nephrolithiasis","Ureteral Stent Discomfort","2026-05-27",{"date":122,"type":40},"2026-05-29",{"date":124,"type":22},"2026-06",{"date":126,"type":22},"2027-04",{"name":46,"class":47},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":48},"100559616","phase-1-honokiol-in-early-stage-resectable-non-small-cell-lung-cancer-100559616","NCT06566443","Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer","Phase I Trial Evaluating the Safety of the Dietary Supplement Honokiol in Early-Stage Resectable Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. The patient provides written informed consent for the trial. Spanish speaking patients will be included and translation services will be provided as needed.\n2. Male or female, 18 years of age or older, on the day of informed consent signing.\n3. Early stage NSCLC eligible for upfront definitive surgical resection\n4. Measurable disease according to the Response evaluation criteria in solid tumors (RECIST 1.1) within 30 days of treatment.\n5. Expected life expectancy of at least 6 months\n6. Adequate organ and marrow function as defined below:\n\n   Hemoglobin ≥9.0 g\u002Fdl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility) Absolute neutrophil count ≥1000\u002FμL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility) Platelet count ≥100,000\u002FμL (without transfusion within 2 weeks of laboratory test used to determine eligibility)- Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB \\[\\>1.5 x ULN\\] is allowed), Aspartate transaminase\u002Falanine transaminase ≤5 x institutional ULN Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL\u002Fmin\u002F1.\n7. Willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.\n\nExclusion Criteria:\n\n1. 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 3 weeks of trial treatment administration.\n2. Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to trial treatment administration or who has not recovered (i.e., ≤ Grade 1 or at baseline) from Adverse Events (AEs) due to a previously administered agent.\n3. Use of agents that target the mitochondrial metabolism.\n4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n5. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n6. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.\n7. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of ≥ 2.\n9. Patients must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Patients with ≤ Grade 2 neuropathy may be eligible. If patient received major surgery, she must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting the trial treatment.\n10. Active infection requiring systemic therapy.\n11. Confirmed positive pregnancy test in women of childbearing potential (WOCBP).",{"count":136,"type":22},15,[25],"This is a Phase I Trial evaluating the safety of the dietary supplement honokiol for lung cancer chemoprevention. Female or male patients aged 18 years, or older, with early stage lung cancer who have been scheduled for curative surgery will be eligible for participation in the study. The study will only enroll patients with stage I lung cancers less than 4 cm, given the recent approval of neoadjuvant chemotherapy and nivolumab for stage IB tumors \\> 4 cm. Approximately, 15 patients will be enrolled in the study. They will take the study drug, honokiol, for 2 weeks prior to the surgery. The primary endpoint will be the Maximum Tolerated Dose (MTD) of honokiol.",[140],"Carcinoma, Non-Small-Cell Lung","2026-05-26",{"date":143,"type":40},"2026-05-28",{"date":145,"type":40},"2025-02-13",{"date":147,"type":22},"2027-08",{"name":46,"class":47},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":4},"100614705","io-vancomycin-into-the-medial-malleolus-vs-iv-administration-in-revision-tka-100614705","NCT07283068","IO Vancomycin Into the Medial Malleolus vs IV Administration in Revision TKA","Intraosseous (IO) Vancomycin Into the Medial Malleolus vs Intravenous (IV) Administration in Revision Total Knee Arthroplasty (TKA)","Inclusion Criteria:\n\n* Patient is undergoing a revision total knee arthroplasty where in the opinion of the investigator, the patient's existing tibial component excludes the tibial tubercle as a valid intraosseous injection site.\n* Patient is able to understand the study design and intervention and gives informed consent to participate in the study.\n* Age \\> 18 years.\n\nExclusion Criteria:\n\n* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).\n* Patient received or is scheduled to receive intravenous Vancomycin within 7 days prior to their planned revision procedure.\n* Any hardware, condition, or anatomic status that prevents the medial malleolus from being a viable intraosseous injection site.\n* Refusal to participate\n* Any condition, in the opinion of the primary investigator, that deems the participant unsuitable for participation in the research study.",{"count":157,"type":22},40,[60],"Purpose of this study is to compare the efficacy of intravenous and intraosseous antibiotic administration techniques during revision total knee arthroplasty",[161],"Revision Total Knee Arthroplasty","NOT_YET_RECRUITING","2026-04-17",{"date":165,"type":40},"2026-04-20",{"date":167,"type":22},"2026-06-15",{"date":169,"type":22},"2030-06-15",{"name":46,"class":47},{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":23,"phases":179,"briefSummary":180,"conditions":181,"keywords":183,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":48},"100580174","phase-1-phase-i-trial-of-5-fluorouracil-5fu--based-therapy-in-combination-with-hydroxytyrosol-ht-in-patients-with-advanced-or-metastatic-colorectal-cancer-100580174","NCT06833866","Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\nA subject will be eligible for inclusion in this study only if all the following criteria are met:\n\n1. Male or female ≥18 years of age.\n2. Histopathologically or cytologically confirmed advanced or metastatic CRC.\n3. Patient who is eligible for first-line therapy for advanced or metastatic CRC, such as 5FU-based therapy.\n4. Measurable disease per the RECIST v1.1.\n5. Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Life expectancy ≥6 months.\n7. Females of childbearing potential must agree to use birth control during the study and for 30 days after your last dose of HT, at least 9 months after your last dose of oxaliplatin, at least 3 months after your last dose of 5-FU, and at least 6 months after your last dose of irinotecan.\n8. Male who are sexually active and their partner can become pregnant, must agree to use birth control during the study and for 30 days after their last dose of HT, at least 6 months after their last dose of oxaliplatin, at least 3 months after his last dose of 5-FU, and at least 3 months after his last dose of irinotecan.\n\n   \\-\n\nExclusion Criteria:\n\nSubjects must meet all the inclusion criteria listed above in Section 10.1 and none of the following exclusion criteria:\n\n1. Hematology laboratory values of:\n\n   1. WBC of \\\u003C3000 and absolute neutrophil count ≤1500 cells\u002Fmm3 with the Fy null phenotype.\n   2. Platelets ≤100,000 cells\u002Fmm3\n   3. Hemoglobin ≤9 g\u002FdL (Fe infusion is allowed to correct anemia in iron deficient anemia patients, per standard-of-care)\n2. Hepatic laboratory values of aspartate transaminase or alanine aminotransferase:\n\n   1. \\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or\n   2. \\>2.5 × ULN if no liver metastases are present.\n3. Serum albumin \\\u003C2.8 g\u002FdL.\n4. Total bilirubin \\>1.5 × ULN or \\>1.5 mg\u002FdL.\n5. Prothrombin time (PT) or international normalized ratio (INR) \\>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.\n6. Estimated glomerular filtration rate \\\u003C50 mL\u002Fmin.\n7. Positive pregnancy test, pregnant, or breastfeeding (female patients only).\n8. Any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.\n9. Any clinically significant and\u002For uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:\n\n   1. Arrhythmia\n   2. Bradycardia\n   3. Tachycardia\n   4. Symptomatic valvular disease\n   5. Symptomatic congestive heart failure classified by the New York Heart Association as Class III or IV\n   6. Unstable angina pectoris.\n10. Myocardial infarction within the past 6 months.\n11. Active bleeding diathesis (platelets less than 100,000 or active bleeding)\n12. Current complaints of persistent constipation or history of chronic constipation, bowel obstruction, or fecaloma within the past 6 months.\n13. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other immunosuppressive agents\n14. Known history and\u002For uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.\n15. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.\n16. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month. Note: Influenza vaccine will be allowed if administered \\>21 days.\n17. Receipt of any investigational agent or study treatment within the past 30 days.\n18. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months.\n19. Patients must be able to swallow oral capsules.\n20. Participants with metastatic CRC and microsatellite instability-high or deficient mismatch repair tumors.\n21. surgical Surgery, within 12-months or less.\n22. For patients to be treated with bevacizumab: history of gastrointestinal fistula or perforation, major surgery within 28 days of study treatment initiation, recent hemorrhage, arterial thromboembolic events or deep venous thrombosis within 6 months, uncontrolled hypertension (i.e., BP \\> 150\u002F90 mm Hg), proteinuria, and hemoptysis.\n\n    \\-",{"count":178,"type":22},33,[25],"This is a phase I study investigating the safety and antitumor activity of 5FU-based therapy (FOLFIRI\u002FFOLFOX + Biologics) in combination with Hydroxytyrosol (HT) as a treatment for patients with advanced or metastatic colorectal cancer.\n\nPatients will receive: 1 capsule of HT 25 mg daily for 2 weeks before beginning 5FU-based therapy (FOLFIRI\u002FFOLFOX + Biologics), 1 capsule of HT (25 mg) daily for 2 weeks while receiving the FOLFIRI\u002FFOLFOX + Biologics, until sign of disease progression.\n\nThe prescribed FOLFIRI\u002FFOLFOX administer as: Irinotecan 180 mg\u002Fm² intravenously (IV) over 90 minutes concurrently with Leucovorin 400 mg\u002Fm² IV over 120 minutes, followed by Fluorouracil 400-500 mg\u002Fm² IV bolus then 2400-3000 mg\u002Fm² IV infusion over 4-6 hours with or without, the designated Biologics, a standard dose of Cetuximab or Bevacizumab will be administered in 2-week cycles until disease progression or un-tolerated toxicity",[182],"Advanced or Metastatic CRC",[184],"Colorectal Cancer","2026-04-16",{"date":163,"type":40},{"date":188,"type":40},"2024-12-04",{"date":190,"type":22},"2027-12-01",{"name":46,"class":47},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":48},"100577463","phase-1-anterior-cruciate-ligament-acl-reconstruction-with-autologous-fat-pad-derived-mesenchymal-stem-cells-100577463","NCT06798623","Anterior Cruciate Ligament (ACL) Reconstruction With Autologous Fat Pad Derived Mesenchymal Stem Cells","Inclusion Criteria:\n\n* Patients 18 years of age or older who are scheduled to undergo anterior cruciate ligament (ACL) reconstruction with bone-to-bone (BTB) patellar tendon autograft with the Principal Investigator (PI).\n* Receiving post-surgery physical therapy at a Houston Methodist physical therapy (PT) clinic.\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Prior surgery on affected knee\n* Diabetes\n* Root repair, inflammatory arthropathy, or any other concomitant procedure that cannot follow an accelerated PT protocol or any concomitant procedure that the PI deems exclusionary\n* Unable to attend physical therapy at Houston Methodist\n* Vulnerable populations\n* Immunocompromised patients such as those being treated for cancer, kidney failure, etc.\n* Heart disease (including systolic blood pressure \\>180 mm Hg or heart failure)\n* Active infections\n* Non-English-speaking patients\n* Any known metal implants or allergy to contrast agents\n* Pregnancy (as part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative result is required to proceed with surgery per SOC and thus, participate in the study) and those planning to become pregnant during the duration of the study\n* Any condition with known bleeding disorders, thrombus formation risk factors, or overlying wound and skin infections\n* Any condition in the opinion of the primary investigator that would compromise the integrity of the data collection or outcomes being assessed\n* Any other medical condition that in the opinion of the primary investigator would constitute a relative contraindication to study participation (e.g., Ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, SLE, scleroderma, polymyositis, Ehlers-Danlos syndrome, osteoporosis)",{"count":136,"type":22},[25],"This study is designed as a prospective, open label, single arm pilot clinical study that will establish the safety and efficacy of a single injection of mesenchymal stromal cells in patients. Each subject will receive one intra-articular injection of autologous mesenchymal stromal cells derived from infrapatellar fat pad (FP-MSC) tissue samples collected from the subject during anterior cruciate ligament (ACL) reconstruction surgery.",[202],"Anterior Cruciate Ligament Reconstruction","2026-04-15",{"date":185,"type":40},{"date":206,"type":40},"2026-03-24",{"date":208,"type":22},"2030-03",{"name":46,"class":47},{"id":211,"slug":212,"hasResults":12,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":220,"briefSummary":221,"conditions":222,"keywords":225,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100545429","phase-1-cbd-for-pain-following-orthopedic-shoulder-surgery-100545429","NCT06381791","CBD for Pain Following Orthopedic Shoulder Surgery","Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial","CBD","Inclusion Criteria:\n\n* Above the age of 18 years old\n* Undergoing a rotator cuff repair surgery\n* Receiving standard anesthesia during surgery\n* If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment.\n\nExclusion Criteria:\n\n* Under the age of 18 years old\n* History of revision shoulder arthroplasty\n* History of liver disease or impairment\n* Are currently taking valproate or clobazam\n* Are currently taking a moderate\u002Fstrong CYP3A4 or CYP2C19 inhibitor\n* Are currently taking a strong CYP3A4 or CYP2C19 inducer\n* Are currently taking narcotics\n* History of substance\u002Falcohol abuse\n* Those currently or previously under the care of a pain management specialist\n* History of marijuana\u002Fcannabidiol (not including topical) regular use within the past 6 months\n* Allergy related to cannabidiol\n* Allergy related to sesame seeds\n* Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.)\n* If you are taking any medications with known risks for suicidal behavior and ideation\n* If you have a diagnosed psychiatric disorder\n* If you are untreated for a diagnosed sleeping disorder\n* If you are actively breastfeeding\n* Patients currently taking central nervous system (CNS) depressants\n* Patients currently taking other drugs with known hepatotoxicity\n* Vulnerable populations.\n\nPatients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.",{"count":219,"type":22},80,[25,26],"The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.\n\nResearchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.\n\nParticipants will:\n\n* track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.\n* Complete two short surveys. Once before surgery and once after.\n* Have bloodwork tested after surgery",[223,224],"Shoulder Osteoarthritis","Rotator Cuff Injuries",[216,226,227],"Cannabidiol","Epidiolex",{"date":185,"type":40},{"date":230,"type":40},"2024-05-24",{"date":232,"type":22},"2027-12-30",{"name":46,"class":47},{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":23,"phases":243,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":48},"100596225","phase-2-trial-of-5-fluorouracil-5fu-based-therapy-in-combination-with-fruquintinib-in-patients-with-locally-advanced-unresectable-or-metastatic-colorectal-cancer-100596225","NCT07042685","Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Male or female ≥18 years of age.\n2. Written informed consent is required before performing any trial-specific tests or procedures. Signing of the informed consent form can occur outside the 28-day screening period.\n3. Histopathologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer. The study will include an all-comer population, meaning that patients will not be excluded based on specific molecular markers such as microsatellite instability-high (MSI-H) or B-Raf proto-oncogene mutations (BRAF mutations). However, as part of the Standard of Care, comprehensive molecular testing will be performed to assess MSI status, and other relevant biomarkers. For patients with MSI-H or BRAF mutations confirmed, treatment may be adjusted per Standard of Care practices.\n4. Measurable disease per RECISTv1.1.\n5. No prior systemic treatment. Patients with resected disease who later develop unresectable recurrence without prior systemic therapy remain eligible.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy ≥6 months per treating physician's assessment.\n8. Patients of childbearing potential must agree to use an adequate method of contraception during the study and for 30 days after the last dose of study treatment.\n9. Patients must be able to swallow oral tablets.\n\nExclusion Criteria:\n\n1. Hematology laboratory values of:\n\n   1. Absolute neutrophil count ≤1500 cells\u002Fmm3\n   2. Platelets ≤100,000 cells\u002Fmm3\n   3. Hemoglobin ≤9 g\u002FdL\n   4. White blood count ≤3000 cells\u002Fmm3.\n2. Hepatic laboratory values of aspartate transaminase (AST) or alanine aminotransferase (ALT):\n\n   1. \\>5 × upper limits of normal (ULN) if the documented history of hepatic metastases; or\n   2. \\>2.5 × ULN if no liver metastases are present.\n3. Serum albumin \\\u003C2.8 g\u002FdL.\n4. Total bilirubin \\>1.7 mg\u002FdL × ULN.\n5. Prothrombin time (PT) or international normalized ratio (INR) \\>1.5 × ULN. Note: Patients receiving therapeutic doses of anticoagulant therapy may be considered eligible if PT and INR are within the acceptable institutional therapeutic limits.\n6. Serum creatinine or serum urea \\>1.5 × ULN.\n7. Estimated glomerular filtration rate \\\u003C50 mL\u002Fmin.\n8. Urine dipstick or urinalysis with protein ≥2+ or 24-hour urine protein ≥1.0 g\u002F24-h. Subjects with 1+ proteinuria must undergo a 24-hour urine collection to assess urine protein level.\n9. Positive pregnancy test, pregnant, or breastfeeding for all women of child-bearing potential.\n10. Per treating physician's assessment, any other clinically significant laboratory abnormality that would compromise patient safety or the outcome of the study.\n11. Any clinically significant and\u002For uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study including, but not limited to:\n\n    1. Arrhythmia\n    2. Bradycardia\n    3. Tachycardia\n    4. Symptomatic valvular disease\n    5. Symptomatic congestive heart failure is classified by the New York Heart Association as Class III or IV\n    6. Unstable angina pectoris.\n12. Myocardial infarction within the past 6 months from consent.\n13. Active bleeding diathesis.\n14. Current complaints of persistent constipation or history of chronic constipation, untreatable bowel obstruction, or fecaloma within the past 6 months from consent.\n15. Receiving chronic treatment with corticosteroids ≥5 mg of prednisone per day (or equivalent) or other systemic immunosuppressive agents. Topical or nasal corticosteroids are allowed.\n16. Known history and\u002For uncontrolled hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV)-1 or HIV-2.\n17. History of galactose intolerance, deficiency of Lapp lactase, or glucose-galactose malabsorption.\n18. History of malignancy or active treatment for malignancy other than CRC (i.e., radiation or chemotherapy, including monoclonal antibodies) within 5 years. Note: Patients with squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ, resected low-grade prostate cancer, or other malignancies that in the opinion of the investigator are considered cured may participate.\n19. Receipt of live, attenuated vaccine (e.g., intranasal influenza, measles, mumps, rubella, varicella) or close contact with someone who has received a live, attenuated vaccine within the past 1 month from consent. Note: Influenza vaccine will be allowed if administered \\>21 days.\n20. Receipt of any investigational agent or study treatment within the past 30 days from consent for a condition other than CRC.\n21. Receipt of any protein or antibody-based therapeutic agents (e.g., growth hormones or monoclonal antibodies) within the past 3 months from consent for a condition other than CRC.\n22. Uncontrolled hypertension\n23. Active infection requiring treatment\n24. Recent history of major surgery\n25. Thromboembolic events during the past 6 months\n26. Adults unable to consent\n27. Prisoners",{"count":242,"type":22},50,[26],"This Phase II clinical trial at Houston Methodist Neal Cancer Center is evaluating the safety and efficacy of combining 5-Fluorouracil (5FU) -based chemotherapy (either FOLFIRI: folinic acid, 5FU, irinotecan; or mFOLFOX6: folinic acid, 5FU, oxaliplatin) with fruquintinib as a first-line treatment for patients with locally advanced unresectable or metastatic colorectal cancer. Fifty patients will receive treatment in 28-day cycles, with fruquintinib initially dosed at 4 mg daily and potentially increased to 5 mg if no significant toxicities are observed. After six months, patients showing stable disease or better will transition to a maintenance phase with 5FU and fruquintinib, continuing until disease progression or other discontinuation criteria are met. The primary endpoint is time to progression based on RECIST v1.1 criteria, while secondary endpoints include safety, tolerability, and duration of response. The trial is being conducted across multiple Houston Methodist hospitals and is currently the only first-line CRC trial available in the system. If successful, it could offer a new therapeutic option and inform future treatment guidelines for advanced colorectal cancer.",[246],"Metastatic Colorectal Cancer (CRC)",[248,249,250],"first line","CRC","metastatic","2026-04-08",{"date":253,"type":40},"2026-04-09",{"date":255,"type":40},"2026-01-27",{"date":44,"type":22},{"name":46,"class":47},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":48},"100622440","phase-2-trial-to-study-anti--hcmv-therapy-in-breast-cancer-patients-with-progressive-intracranial-metastases-and-cmv-infection-100622440","NCT07383649","Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection","Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV Study)","Inclusion Criteria:\n\n1. Male or female aged \\>18 years at the time of consent\n2. Breast cancer with progressive brain metastases supra and\u002For infratentorial. Patients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon\u002Fradiation oncologist.\n3. At least one non irradiated, untreated progressive brain metastases site\n4. Serum HCMV DNA by real time PCR \\> 250 copies\u002Fml or positive CMV Ig G or Ig M.\n5. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. If the patient is unable to consent for any reason a legally authorized guardian may provide consent on their behalf. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act) will be obtained from the patient prior to performing any protocol-related procedures, including screening evaluations.\n6. Metastatic breast cancer who has systemically no evidence of disease, complete remission, partial remission, stable or progressive disease\n7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n8. Adequate hematology without ongoing transfusion support (hemoglobin \\> 9 g\u002Fdl, absolute neutrophil count (ANC) \\> 1500 per mm3 , platelets \\> 100,000 per mm3)\n9. Adequate renal and hepatic function (creatinine clearance \\[CrCL\\] \\> 60 mL\u002Fmin, bilirubin x:≤1.5 upper limit of normal (ULN), aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] ≤ 2.5 x ULN and serum albumin ≥ 3 g\u002Fdl.\n10. Other CMV treatment if clinically indicated per physician's choice\n11. Evidence of postmenopausal status or negative serum pregnancy test for premenopausal female patients. Negative serum β-human chorionic gonadotropin pregnancy test within 7 days prior to the first dose of study treatment for premenopausal patients. Women will be considered postmenopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n\n    The following age-specific requirements apply:\n12. Women \\\u003C50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n13. Women ≥50 years of age would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \\>1 year ago, had chemotherapy-induced menopause with last menses \\>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n14. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up.\n\nExclusion Criteria:\n\n1. Single resectable intracranial lesion\n2. Last intracranial progression free survival \\> 12 months\n3. All progressive brain metastases have been radiated\n4. Brain metastases needing immediate local intervention such as mass effect, herniation, active neurological symptoms, increased intracranial pressure, those near vital structures like the motor cortex, proximity to the optic nerve\u002Fchiasm or brain stem etc (can still be included if there are any other non-radiated progressive brain metastases) Multidisciplinary discussion with neurosurgery and radiation oncology will be needed to determine which patients may be safely enrolled on the trial.\n5. Active pregnancy or breast feeding\n6. Women of childbearing potential or fertile men unwilling to use effective contraception (Section 6.2, Table 6) during study and up to three months after treatment discontinuation.\n7. Known psychiatric disorder that causes poor cooperation with the trial requirements.\n8. Participants with previous other malignancies must have had at least a 3-year disease free interval, except those with non-melanoma skin cancer or carcinoma in situ of cervix\n9. Participation in another clinical study with an investigational product within 28 days prior to the first dose of study treatment.\n10. Concurrent enrollment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n11. Unresolved or unstable adverse events (AEs) from prior administration of another investigational drug, per investigators' discretion.\n12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of study treatment.\n13. Non-English-speaking subjects will not be enrolled in this study since the neurocognitive tests including DKEFS, RAVLT and TMT are not validated to be scored in other languages.",{"count":266,"type":22},28,[26],"This is a phase II trial with an initial safety lead-in evaluating the efficacy, safety, neurocognitive, and quality-of-life outcomes of anti-cytomegalovirus (CMV) therapy and standard-of-care (SOC) in patients with anti-human cytomegalovirus (HCMV)-reactivated brain metastases. Male and female patients, aged ≥18 years, who have metastatic breast cancer with progressive brain metastases and CMV viremia (\\> 250 copies\u002Fml) or positive CMV IgG or IgM will be eligible to participate in the trial.\n\nPatients can proceed with SRS as long as at least 1 lesion which is 2 cm or less in a noncritical area in the brain is spared as per the discretion of treating neurosurgeon\u002Fradiation oncologist. At least 10 patients will be enrolled in the initial safety lead-in followed by the Phase II trial which will include 18 patients.\n\nAnti-HCMV therapy, oral Valganciclovir will be given to patients at 900 mg twice a day for 2 weeks. After the induction period, the maintenance will be continued with valganciclovir at 450 mg twice daily for 4 weeks (28 days).",[270,271],"Brain Cancer Metastatic","CMV Viremia","2026-04-07",{"date":251,"type":40},{"date":275,"type":22},"2026-05",{"date":277,"type":22},"2030-05",{"name":46,"class":47},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":296,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":48},"100555372","phase-4-intraosseous-morphine-administration-during-anterior-cruciate-ligament-reconstruction-100555372","NCT06511232","Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction","Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: A Randomized Control Trial","Inclusion Criteria:\n\n* Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft\n* Patients aged between 18-40 years old at the time of surgery\n\nExclusion Criteria:\n\n* Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB\n* Patients younger than 18 years old or older than 40 years old\n* Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status\n* Patients with a history of substance abuse\n* Vulnerable populations\n* Patients on chronic pain medication within the last 6 months\n* BMI \\>\u002F= 35\n* Allergy to morphine\n* Unwilling to participate\n* Any additional reason the PI deems reasonable","40 Years",{"count":288,"type":22},84,[290],"PHASE4","The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.",[293,294,295],"Anterior Cruciate Ligament Tear","Anterior Cruciate Ligament Injuries","Anterior Cruciate Ligament Rupture",{"date":253,"type":40},{"date":298,"type":40},"2024-08-19",{"date":300,"type":22},"2029-07-31",{"name":46,"class":47},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":308,"sex":17,"minAge":309,"maxAge":56,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":48},"100533394","augmenting-rehabilitation-outcomes-and-functional-neuroplasticity-using-epidural-stimulation-of-cervical-spinal-cord-100533394","NCT06225245","Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord","Inclusion Criteria:\n\n* All participants must provide a signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female aged 22 - 65 years old.\n* Must provide documentation from personal primary treating physician that reports stable medical condition.\n* Able to passively range bilateral upper extremities within normal mobility parameters including:\n\n  * greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension;\n  * greater than 120 degrees of elbow flexion and reach elbow extension of approximately 150 degrees;\n  * neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;\n  * ability to passively flex and extend fingers.\n* Maintain current oral anti-spasticity regimen\u002Fdosage as approved by study physician with no change in regular use that may affect study outcomes.\n* Six (6) months to 20 years post spinal cord injury.\n* Non-progressive spinal cord injury.\n* Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.\n* Neurological level of injury above T2.\n* Eligible for fMRI per safety questionnaire.\n* Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.\n\nExclusion Criteria:\n\n* Currently involved in another rehabilitation training study.\n* Lower motor neuron injury revealed in the upper limbs.\n* Stabilization hardware in the cervical spine, preventing implantation of ESS system.\n* Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).\n* Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).\n* Intrathecal baclofen pump therapy for spasticity.\n* Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.\n* Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).\n* Clinically significant depression, psychiatric disorders, or ongoing drug abuse.\n* Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.\n* Body Mass Index (BMI) over 30.\n* Pregnancy.",true,"22 Years",{"count":311,"type":22},12,[60],"The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training.\n\nThis is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury",[315,316],"Spinal Cord Injuries","Cervical Spinal Cord Injury",{"date":251,"type":40},{"date":319,"type":40},"2024-08-06",{"date":321,"type":22},"2027-01-01",{"name":46,"class":47},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":308,"sex":17,"minAge":82,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":332,"phases":4,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":48},"100483989","selective-pet-imaging-of-astrocytes-and-microglia-in-alzheimers-disease-100483989","NCT05582200","Selective PET Imaging of Astrocytes and Microglia in Alzheimer's Disease","Patients with Alzheimer's disease\n\nInclusion criteria:\n\n* Individuals of either sex, 50-90 years of age.\n* Meeting research criteria for AD (McKhann, Knopman et al. 2011).\n* With a CDR (Morris 1993) score of 1-3.\n* Fluent in English or Spanish.\n* Have sufficient communication and comprehension ability to consent to the performance of the study or have a legally authorized representative.\n\nExclusion criteria:\n\n* Inability to undergo MRI or PET for any reason, including severe claustrophobia.\n* History of large stroke or brain trauma, multiple sclerosis or other brain disorder that, in the judgment of the PI may confound the study.\n* Pregnancy. In women in whom the possibility of pregnancy cannot be excluded, a pregnancy test must be performed on site the morning of any PET visit and a negative result together with a physician interview are required prior to the administration or any radiopharmaceutical.\n* Research radiation exposure greater than 50 mSv effective dose within 12 months including radiation exposure from this study.\n\nHealthy volunteers:\n\nInclusion criteria:\n\n* Individuals of 18-90 years of age.\n* Negative amyloid accumulation determined by PET (only for the comparison with AD).\n* Fluent in English.\n* Have enough communication and comprehension ability to consent to the performance of the study.\n\nExclusion criteria:\n\n* Inability to undergo MRI or PET for any reason, including severe claustrophobia.\n* Brain disorder, other than idiopathic headache.\n* Current primary Axis I or II psychiatric disorder.\n* Current use of psychotropic or anti-epileptic medication.\n* Substance abuse during the past two years.\n* Active cancer, metabolic encephalopathy, infection, cardiovascular disease.\n* Active hematological, renal, pulmonary, endocrine or hepatic disorders, except for treated thyroid disease.\n* Pregnancy. In women in whom the possibility of pregnancy cannot be excluded, a pregnancy test must be performed on site the morning of any PET visit and a negative result together with a physician interview are required prior to the administration or any radiopharmaceutical\n* Research radiation exposure greater than 50 mSv effective dose within 12 months including radiation exposure from this study.\n* Only for the subjects undergoing the blocked scan with selegiline: known contraindications to selegiline, including hypersensitivity to the drug and use of opioids, such as meperidine and some antidepressants such as bupropion.","90 Years",{"count":331,"type":22},71,"OBSERVATIONAL","Inflammation occurs in many brain diseases including Alzheimer's disease. In Alzheimer's disease, an abnormal protein called amyloid starts accumulating decades before the start of forgetfulness. However, scientists have reported that inflammation but not amyloid is linked to forgetfulness and the topography of brain inflammation and tau buildup are closely correlated in patients with mild cognitive impairment due to Alzheimer's disease. New medications are under development to help healing and prevent permanent damage in the brain. To see if inflammation is improving or getting worse with these medications, investigators can watch inside of the brain using a special camera called positron emission tomography (PET). It is currently possible to watch inflammation in the brain by taking pictures of a molecule called translocator protein (TSPO). But the problem is that by imaging TSPO, investigators can catch changes in more than one kind of cells. The information is not specific to each cell type. Such vague information is not completely useful to monitor the effect of new medications for inflammation. This proposal attempts to develop a novel method to capture changes in each of two major players in inflammation, microglia and astrocytes. To do so, investigators will take selective pictures of one cell type by using a novel imaging agent for PET. Investigators will also take PET pictures of TSPO. Investigators will process these two kinds of PET pictures using advanced mathematical methods and extract specific information on microglia and astrocytes. Our novel method will be useful to monitor new therapies to treat inflammation in the brain.",[335,336],"Alzheimer Disease","Healthy","2026-03-31",{"date":339,"type":40},"2026-04-06",{"date":341,"type":40},"2023-01-20",{"date":343,"type":22},"2028-10-31",{"name":46,"class":47},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":360,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":48},"100360313","phase-1-ocrelizumab-for-psychosis-by-autoimmunity-100360313","NCT03971487","Ocrelizumab for Psychosis by Autoimmunity","Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity","OPA","Inclusion Criteria:\n\n* Individuals of either sex, 18-35 years of age.\n* Having an active psychotic disorder meeting DSM-5 criteria, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI).\n* A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms.\n* Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age.\n* Ability to assent or consent to the performance of the study and participate in testing procedures.\n\nExclusion Criteria:\n\n* The dose of antipsychotic medication (if they are on one) has been changed less than two weeks prior to baseline PANSS testing (Visit 2, see below).\n* Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization.\n* Vaccinated with a live-attenuated vaccine less than 4 weeks before ocrelizumab infusion or with a non-live vaccine less than 2 weeks before infusion.\n* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus, syphilis, tuberculosis, PML).\n* History of brain tumor, stroke, severe head trauma or multiple sclerosis.\n* Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.\n* In the judgment of the PI, psychosis related to substance abuse or metabolic disorders.\n* Pregnancy or lactation.\n* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.\n* History of or currently active primary or secondary immunodeficiency.\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Contraindications to or intolerance of oral or IV corticosteroids.","35 Years",{"count":157,"type":22},[25,26],"Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to \"friendly fire.\" Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.",[358,359],"Schizo-Affective Type of Psychosis","Schizophrenia",[361,362],"schizo-affective psychosis","schizophrenia",{"date":364,"type":40},"2026-04-01",{"date":366,"type":40},"2019-10-01",{"date":368,"type":22},"2028-10-30",{"name":46,"class":47},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":376,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":48},"100557307","phase-1-atra-and-carfilzomib-in-plasma-cell-myeloma-patients-100557307","NCT06536413","ATRA and Carfilzomib in Plasma Cell Myeloma Patients","Phase IB\u002FII Study Combining All-Trans Retinoic Acid (ATRA) With Carfilzomib Based Therapy in Plasma Cell Myeloma Patients Refractory to Carfilzomib","ATRA","Inclusion Criteria:\n\n1. Age ≥ 18 years with relapsed\u002Frefractory multiple myeloma documented according to International Myeloma Working Group (IMWG) criteria.\n2. Previously treated with at least three lines of therapy which would include Immunomodulatory drugs (IMiDs), Proteosome inhibitors (including carfilzomib), anti-CD 38 antibodies and failed to achieve a minor response after completing at least 2 cycles of carfilzomib-based therapy or are relapsed while on therapy.\n3. Patient or legal guardian voluntarily can sign informed consent.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2\n5. Adequate organ function defined as:\n\n   1. Hemoglobin ≥8 g\u002FdL (baseline or after Peripheral Red Blood Cell transfusion), Platelet count \\>75,000 and Absolute Neutrophil Count \\>1000\u002F micro liter.\n   2. Left Ventricular Ejection fraction ≥50%\n   3. Creatinine Clearance ≥ 30 ml\u002Fmin\n   4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n   5. Total bilirubin ≤ 1.5 × ULN\n6. Measurable disease requiring treatment defined as patients having one or more of the criteria below:\n\n   1. Serum M protein ≥ 0.5 g\u002FdL or\n   2. Urine M-protein ≥ 200 mg\u002F24 hours or\n   3. Serum free light chain (SFLC) ≥ 100 mg\u002FL (involved light chain) and an abnormal serum\n   4. kappa lambda ratio.\n7. If previous autologous stem cell transplantation, must have fully recovered from transplant related toxicities and be \\>60 days from transplant and have had hematologic recovery independent of growth factor support.\n8. Willingness to undergo interim bone marrow biopsy as scheduled or if felt to be medically indicated.\n9. Life Expectancy ≥ 6 months\n10. Women with childbearing potential and men should practice at least one of the following methods of birth control:\n\n    1. Total abstinence from sexual intercourse (periodic abstinence not acceptable);\n    2. Surgically sterile partner(s) including vasectomy, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy;\n    3. Intrauterine device with an additional method of contraception to make two effective methods of contraception during treatment with Vesanoid;\n    4. Double-barrier method (condom + diaphragm or cervical cap with spermicide, contraceptive sponge, jellies, or cream);\n    5. Hormonal contraceptives (oral, parenteral, vaginal ring, or transdermal) for at least 3 months prior to study drug administration. If hormonal contraceptives are used, the specific contraceptive must have been used for at least 3 months prior to study drug administration. If the patient is currently using a hormonal contraceptive, she should also use a barrier method during this study Women of child-bearing potential must have a negative results of a pregnancy test performed at initial screening on a serum sample obtained within 21 days prior to C1D1, and prior to dosing on a urine sample obtained within 72 hours of the first study drug administration. Males must refrain from sperm donations from date of C1D1 to 90 days after the last date of the study drug.\n\nExclusion Criteria:\n\n1. Non-secretory or hyposecretory multiple myeloma, defined as \\\u003C0.5 g\u002FdL M-protein in serum, \\\u003C200 mg\u002F24-hour urine M-protein, or disease only measured by serum free light chain.\n2. Plasma Cell Leukemia (Previously treated Plasma Cell Leukemia can be included per PI discretion)\n3. Concurrent light chain amyloidosis\n4. Central nervous system involvement (patients with known brain metastases have poor prognosis and often develop progressive neurologic dysfunction that may confound the evaluation of neurologic and other Adverse Events while on ATRA).\n5. Pregnant or breast feeding\n6. Severe, active, recurrent, or intercurrent infection (viral, bacterial, fungal), or diagnosis of neutropenia and fever within one week of C1D1.\n7. History of Allogeneic hematopoietic cell transplantation or solid organ transplantation.\n8. Unstable angina pectoris, cardiac arrhythmia or \\> New York Heart Failure association class II cardiac failure, defined as comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain.\n9. Patient has a significant history of renal, neurologic (peripheral neuropathy), psychiatric, endocrinologic (diabetes mellitus), metabolic, immunologic, cardiovascular, pulmonary, hepatic disease, or significant social situation within the past 6 months that, in the opinion of the investigator, would impede his\u002Fher ability to fully participate in the study. For patients who have required an intervention for the above diseases within the past 6 months, a case-by-case discussion with the investigator must occur.\n10. On investigational therapies within 12 weeks of enrollment.\n11. Previous allergic reaction or intolerance to a proteasome inhibitor, including carfilzomib, bortezomib, or ixazomib.\n12. Or deemed unfit for the study on evaluation by Investigator.",{"count":379,"type":22},42,[25,26],"This is a Phase IB\u002FII trial that will investigate the safety, tolerability and efficacy of combination therapy using All-Trans Retinoic Acid (ATRA) with Carfilzomib based therapies in plasma cell myeloma also commonly referred as Multiple Myeloma (MM), in patients considered refractory to proteasome inhibitors (PIs). Multiple myeloma is an incurable clonal plasma cell disorder that comprises 10% of all hematologic malignancies. Over the past 30 years the global prevalence of multiple myeloma has risen to 126%, with 85% of diagnoses occurring in patients \\>55 years of age. In the past 15 years, survival has improved considerably, which is attributed to the development of multiple different classes of medications, including proteasome inhibitors. Proteasome inhibitors are the foundation of many multiple myeloma treatments in both transplant eligible and ineligible patients for the past 2 decades. While proteasome inhibitors have improved both progression free survival (PFS) and overall survival (OS), many patients eventually develop disease progression arising from resistance to therapies. As a result, there is an unmet need to overcome resistance and find ways to enhance multiple myeloma sensitivity to proteasome inhibitor toxicity. Carfilzomib, a modified peptide epoxyketone that selectively targets intracellular proteasome enzymes, is approved in combination with dexamethasone in patients that have received ≥1 line of therapy or in combination. There are few studies assessing ways to enhance carfilzomib-mediated multiple myeloma toxicity. All-Trans Retinoic Acid (ATRA) is an oxidative metabolite of retinol (vitamin A) and plays an important role in the regulation of cellular proliferation and differentiation. In a recent pre-clinical study, ATRA was found to enhance sensitivity of carfilzomib-mediated apoptosis in vitro via an interferon beta (IFN-β) response pathway. In the clinical setting, ATRA is a well-tolerated drug that has shown little change in the rate of adverse events in early clinical trials with multiple myeloma. The investigators hypothesize that ATRA enhances sensitivity of multiple myeloma to carfilzomib therapy.",[383],"Multiple Myeloma","2026-03-30",{"date":386,"type":40},"2026-04-03",{"date":388,"type":40},"2024-07-29",{"date":390,"type":22},"2030-07",{"name":46,"class":47},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":17,"minAge":309,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":48},"100532454","harnessing-neuroplasticity-of-postural-sensorimotor-networks-using-non-invasive-spinal-neuromodulation-to-maximize-functional-recovery-after-spinal-cord-injury-100532454","NCT06213012","Harnessing Neuroplasticity of Postural Sensorimotor Networks Using Non-Invasive Spinal Neuromodulation to Maximize Functional Recovery After Spinal Cord Injury","Inclusion criteria\n\n1. All participants must be able to provide a provision of a signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, aged 22-75 years old.\n4. Documentation from the participant's primary treating physician confirming a stable medical condition.\n5. Inability to maintain standing independently without external support due to SCI AIS A-C.\n6. Ability to tolerate at least 15 minutes in an upright (supported) position.\n7. Able to self-transfer from the wheelchair and demonstrate active range of motion of bilateral upper extremities in gravity dependent plane.\n8. Able to passively range bilateral lower extremities within normal mobility parameters including:\n\n   1. greater than 90 degrees of hip flexion and 165 degrees of hip extension;\n   2. greater than 90 degrees of knee flexion and reach neutral knee extension of 180 degrees;\n   3. neutral ankle position reaching a minimum of 90 degrees of dorsiflexion.\n9. Participants should be on a stable intrathecal baclofen or oral anti-spasticity regimen\u002Fdose for the period of the study unless advised otherwise by their physician.\n10. 1 to 30 years post spinal cord injury.\n11. Non-progressive spinal cord injury.\n12. Neurological level of injury below C4 and above T12 (excluding conus injury and\u002For indications of lower motor neuron injury).\n13. Eligible for fMRI per safety questionnaire.\n14. Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.\n15. Able to commit to the full study.\n\nExclusion Criteria:\n\n1. Ability to maintain standing independently without external support.\n2. Currently involved in another rehabilitation training of the lower extremities.\n3. Active pressure sores, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including but not limited to contractures in the upper and lower extremities).\n4. Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).\n5. Intrathecal baclofen pump therapy for spasticity not compatible with 3T MRI.\n6. Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months, resulting in absence of muscle tone and precluding response to electrical stimulation therapy.\n7. Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).\n8. Clinically significant depression, psychiatric disorders, or ongoing drug abuse, including heavy alcohol use.\n9. Any reason the PI or treating physician may deem as harmful to the participant to enroll or continue in the study.\n10. Body Mass Index (BMI) over 30.\n11. Pregnancy.\n12. Use a ventilator or diaphragmatic pacer.\n13. Participants with the following conditions will be excluded from TMS, but may take part in the overall study:\n\n    * Personal or first-degree family history of seizures or epilepsy.\n    * Metal in the head, except mouth implants.\n    * History of suicide attempts.\n    * History of intracranial lesions, increased intracranial pressure, or stroke.\n    * Current use of tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRIs), buproprion (Wellbutrin), or tramadol.","75 Years",{"count":400,"type":22},60,[60],"It has been demonstrated that the human lumbosacral spinal cord can be neuromodulated with epidural (ESS) and transcutaneous (TSS) spinal cord stimulation to enable recovery of standing and volitional control of the lower limbs after complete motor paralysis due to spinal cord injury (SCI). The work proposed herein will examine and identify distinct electrophysiological mechanisms underlying transcutaneous spinal stimulation (TSS) and epidural spinal stimulation (ESS) to define how these approaches determine the ability to maintain self-assisted standing after SCI.",[315,404],"Neuromodulation","2026-03-25",{"date":384,"type":40},{"date":408,"type":40},"2023-12-06",{"date":410,"type":22},"2027-08-31",{"name":46,"class":47},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":428,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":48},"100478536","phase-2-venous-ethanol-for-ventricular-tachycardia-100478536","NCT05511246","Venous Ethanol for Ventricular Tachycardia","Venous Ethanol for Ischemic Left Ventricular Tachycardia","VELVET","Inclusion Criteria:\n\n* Male and female, ages of 18 and 85 years and with a prior ICD implant\n* Diagnosed with ischemic cardiomyopathy: Prior myocardial infarction (pathological Q waves or imaging evidence of regional myocardial akinesis\u002Fthinning in the absence of a non-ischemic cause)\n* One of the following VT events (within last 6 months): a) ≥3 episodes of VT treated with anti-tachycardia pacing (ATP) or anti-arrhythmic drugs; b) ≥1 appropriate ICD shocks; c) ≥3 VT episodes within 24 hr; d) sustained VT below detection rate of the ICD documented by EKG\u002Fcardiac monitor\n* Patients deemed candidates for RF ablation of VT\n* Able and willing to comply with pre-, post-, and follow-up requirements\n* Willing to sign the informed consent\n\nExclusion Criteria:\n\n* Serum creatinine \\>1.5 mg\u002FdL, or creatinine clearance \\\u003C30 ml\u002Fmin\n* Left ventricular (LV) ejection fraction ≤10%\n* Mobile LV thrombus on echocardiography\n* Absence of vascular access to the LV\n* Disease process likely to limit survival to \\\u003C12 months\n* New York Heart Association class IV heart failure\n* Cardiac surgery within the past 2 months (unless VT was incessant),\n* Acute coronary syndrome in the past 2 months (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on EKG)\n* Another reversible cause of VT (e.g. electrolyte abnormalities, drug-induced arrhythmia)\n* Severe aortic stenosis or mitral regurgitation with a flail leaflet\n* Pregnancy\n* Unwilling or unable to provide informed consent\n* Covid-19 positive testing within 14 days of randomization procedure\n* Enrolled, or planning to get enrolled, in another research study during his\u002Fher participation on the Velvet trial","85 Years",{"count":422,"type":22},156,[26],"Comparative effectiveness randomized clinical trial, comparing endocardial radiofrequency ablation alone vs radiofrequency ablation combined with venous ethanol in patients with ischemic ventricular tachycardia -Venous Ethanol for Left Ventricular Ischemic Ventricular Tachycardia -VELVET clinical trial",[426,427],"Ventricular Tachycardia","Ischemic Cardiomyopathy",[429,430,431,432],"Ventricular tachycardia","Coronary veins","Ethanol","Ablation",{"date":384,"type":40},{"date":435,"type":40},"2023-04-12",{"date":437,"type":22},"2028-12-12",{"name":46,"class":47},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":48},"100332064","phase-1-hsv-tk-and-xrt-and-chemotherapy-for-newly-diagnosed-gbm-100332064","NCT03603405","HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM","Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination With Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.","Inclusion Criteria:\n\n* All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses.\n* Life expectancy ≥ 12 weeks.\n\n  \\- Patient can receive second treatment of HSV-tk after 6 months\n* Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers).\n* Patients with leptomeningeal disease may be considered for enrollment into the study.\n* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his\u002Fher designee) with the aid of written information.\n* Willing to provide biopsies as required by the study.\n* WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.\n* WOCBP and men must practice an effective method of birth control\n* Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:\n* serum creatinine \\\u003C 1.5 mg\u002FdL\n* T. bilirubin \\\u003C 2.5 mg\u002FdL, ALT, AST, GGT and Alk Phos \\\u003C 2 x normal\n* Platelet count \\> 100,000\u002Fml , ANC\\> 1500\u002Fml , Hgb\\> 10 gm\u002FdL\n* Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)\n\nExclusion Criteria:\n\n* Prior treatment with immunomodulatory therapy, immunotherapy, and\u002For gene vector therapy in the past 3 months.\n* Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start.\n* Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor.\n* Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.\n* Patients on immunosuppressive drugs (other than steroids for brain edema).\n* In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.\n* In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled.\n* Liver disease, such as cirrhosis or active\u002Fchronic hepatitis B or C.\n* History of or current alcohol misuse\u002Fabuse within the past 12 months.\n* Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector\u002FValacyclovir).\n* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).\n* No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 3 years.\n* The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging\n* The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria.\n* Active IV drug abuse or severe opioid abuse\n* Pregnant or breastfeeding women or women\u002Fmen able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment.\n* Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.\n* Patients \\\u003C 18 years of age\n* Unwilling or unable to comply with the study protocol.",{"count":447,"type":22},62,[25,26],"Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).",[451,452],"Glioblastoma","Anaplastic Astrocytoma",[454],"GBM, AA, Glioblastoma, Astrocytoma",{"date":384,"type":40},{"date":457,"type":40},"2018-02-28",{"date":459,"type":22},"2026-12-31",{"name":46,"class":47},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":476,"leadSponsor":478,"locationsCount":48},"100573581","phase-2-io-vancomycin-spine-100573581","NCT06748144","IO Vancomycin Spine","Intraosseous vs. Intravenous Vancomycin Administration in Spine Surgery","Inclusion Criteria:\n\n* Patient is undergoing open posterior instrumented spinal fusion (PSIF) or transforaminal lumbar interbody fusion (TLIF)\n* Patient is able to give informed consent to participate on the study. LAR consents will not be utilized for this study\n* Age Range \\>18\n\nExclusion Criteria:\n\n* Previous spine surgery if surgeon deems it will affect the study\n* BMI \\> 40\n* Contraindication to receiving vancomycin, cefepime, ancef, or other standard of care pre-operative antibiotic (allergy, medical issue, etc).\n* Inability to administer the IO infusion\n* Refusal to participate\n* Diabetes as defined as uncontrolled A1C \\> 7.5 and eGFR \\\u003C59\n* Immunocompromised or immunosuppressed patients (HIV, Hep C, ESRD, dialysis, transplant, chemo\u002Fradiation treatment in last 6 months, medications)\n* No vulnerable populations",{"count":21,"type":22},[26,470],"PHASE3","The goal of this research is to learn if injecting the antibiotic vancomycin directly into the bone marrow (intraosseous) or IO) during a lumbar (spinal) fusion surgery, is as effective or better than the standard method of giving it vancomycin through a vein (intravenous) or IV) during lumbar fusion surgery.",[473],"Lumbar Fusion Surgery",{"date":405,"type":40},{"date":275,"type":22},{"date":477,"type":22},"2030-04",{"name":46,"class":47},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":486,"maxAge":286,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":490,"conditions":491,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":495,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":499,"locationsCount":48},"100567316","bone-stimulator-for-spondylolysis-100567316","NCT06666608","Bone Stimulator for Spondylolysis","The Efficacy of Bone Stimulator in Treatment and Return-to-Sport for Spondylolysis","Inclusion Criteria:\n\n* Patients between the ages of 16 to 40 years of age diagnosed with symptomatic spondylolysis by one of the investigators\n* Patients who plan to attend prescribed physical therapy\n* Patients who participate in a regular sport whether that be professional, collegiate or recreational\n\nExclusion Criteria:\n\n* Any condition which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions\n* Patients with contraindications to bone stimulator therapy\n* Patients with pacemaker and implantable cardioverter defibrillator\n* Patients with previous spine surgery\n* Patients with metabolic bone conditions\n* Patients who use nicotine products\n* Vulnerable populations\n* Non-English speaking services","16 Years",{"count":488,"type":22},48,[60],"This prospective study aims to investigate the effectiveness of bone stimulator therapy as adjunct treatment of spondylolysis in athletic populations. By evaluating its impact on pain reduction, functional improvement, osseous bony union and return-to-sport time, the investigators seek to provide valuable insights into the role of bone stimulation therapy as a potential treatment modality for this challenging condition.",[492,493,494],"Spondylolysis","Symptomatic Spondylolysis","Athletes",{"date":405,"type":40},{"date":497,"type":40},"2025-12-03",{"date":44,"type":22},{"name":46,"class":47},{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":506,"eligibilityCriteria":507,"healthyVolunteers":12,"sex":508,"minAge":82,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":23,"phases":511,"briefSummary":512,"conditions":513,"keywords":517,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":528,"locationsCount":48},"100521677","neuromodulating-cortical-regions-involved-in-neurogenic-bladder-in-ms-100521677","NCT06072703","Neuromodulating Cortical Regions Involved in Neurogenic Bladder in MS","A Randomized, Sham-Controlled Clinical Trial Evaluating Individualized Neuromodulation of Cortical Regions Involved in Neurogenic Overactive Bladder in Multiple Sclerosis","MSBLADDER","Inclusion Criteria:\n\n* Adult women (≥ 18 years of age)\n* Clinically stable MS defined as ExpandedDisability Status Score (EDSS) ≤ 7.5without exacerbation worsening in the preceding 6 months prior to study entry\n* Neurogenic Lower Urinary Tract Dysfunction symptoms ≥ 3 months with NBSS total ≥ 15\n* Individuals with Montreal Cognitive Assessment (MoCA) score \\>10 will be eligible\n* At least one bladder storage symptoms (e.g., urinary frequency, urinary urgency, nocturia with or without incontinence) indicated by OAB -AT≥ 8\n* Individuals with active urinary tract infection (UTI) will be treated and will be enrolled after negative urinalysis\n\nExclusion Criteria:\n\n* Pregnant\u002Fplanning to become pregnant or nursing\n* Urodynamic findings of bladder outlet obstruction\n* Baclofen or other intrathecal pumps, Pacemakers.\n* History of seizure disorder (SZ), immediate family of SZ disorder, in addition to individuals who are taking any medications such as (bupropion) Wellbutrin or substances (ex: heavy alcohol use) that would lower seizure threshold will be excluded.\n* History of bipolar disorder, or individuals who are taking medications that can exacerbate the condition such as tricyclic antidepressants, selective serotonin reuptake inhibitors, serotonin-nor-epinephrine reuptake inhibitors, anti-psychotics, lithium, bupropion (Wellbutrin) and antihistamines will be excluded.\n* All intracranial lesions and hemorrhagic stroke will be excluded\n* History of moderate to severe heart disease or unstable angina\n* History of Autonomic Dysreflexia\n* History of interstitial cystitis, pelvic radiation\n* Intra-detrusor botulinumtoxinA (BTX-A) injection over the past 6 months\n* Incarcerated patients will be excluded.\n* Active sacral nerve stimulation (SNS) device or any other spinal stimulators\n* Indwelling urethral or suprapubic catheter","FEMALE",{"count":510,"type":22},29,[60],"Neurogenic overactive bladder (NOAB), characterized by urinary frequency, urgency or urgency incontinence symptoms occurring during the storage phase of the bladder, is the most common urinary complaint in multiple sclerosis (MS). Current management options for NOAB in MS have limited efficacy and considerable adverse effects, which underscores the significance of this study and highlights the need for better, less invasive therapies. This novel study investigates brain therapeutic targets that could shift the focus of NOAB management in MS from a bladder-centric focus to brain restoration; specifically modulating the brain regions identified in the prior functional magnetic resonance imagining studies. Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive brain stimulation that can modulate neurons (excite or inhibit) to improve the connectivity of the regions of interest (ROI). The preliminary data demonstrate, for the first time, significant improvement in bladder symptoms in ten women with MS who have voiding dysfunction following multifocal transcranial magnetic stimulation without any treatment-related adverse effects.\n\nThis randomized double-blind, sham-controlled single center clinical trial with an optional open-label extension (OLE) phase is designed to evaluate the effects of targeted rTMS in women with MS and NOAB by investigating restorative reorganization of brain function The main purpose of this study is to determine the effects of individualized repetitive Transcranial Magnetic Stimulation (rTMS) for improving overactive bladder symptoms such as urinary frequency and urgency with or without incontinence in individuals with multiple sclerosis (MS). Patients will undergo initial screening that includes a demographics information, physical exam, past medical and surgical history, medication list, urine pregnancy test (female subjects with childbearing potential), and completion of questionnaires to confirm the eligibility of patients. All eligible patients will be required to complete a functional MRI scan followed by locating the regions of interest through neural navigation system and finally receiving 10 treatment sessions.\n\nSince this is a randomized trial, some patients will receive active treatment\u002F therapy sessions while others will only receive sham or placebo treatments. The total duration to complete all treatment sessions and follow up visits is approximately 4-5 months.",[514,515,516],"Neurogenic Bladder","Multiple Sclerosis","Overactive Bladder",[518,519,520,404],"Neurogenic bladder","Functional Neuroimaging","repetitive Transcranial Magnetic Stimulation (rTMS)","2026-03-18",{"date":523,"type":40},"2026-03-23",{"date":525,"type":40},"2023-10-30",{"date":527,"type":22},"2027-12-31",{"name":46,"class":47},{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":536,"minAge":286,"maxAge":109,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":162,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":48},"100596657","phase-1-stem-cells-for-erectile-dysfunction-post-ralp-100596657","NCT07048314","Stem Cells for Erectile Dysfunction Post RALP","A Randomized Clinical Trial to Assess Safety and Efficacy of Allogeneic Adipose-derived Mesenchymal Stem Cells in Promoting the Recovery of Erectile Function Post Radical Retropubic Prostatectomy of Localized Prostate Cancer","Inclusion Criteria:\n\n1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.\n2. Men aged between 40 and 70 (inclusive) years old\n3. Localized prostate cancer: Clinical stage T1-T2, N0, M0\n4. Gleason score \\\u003C 7\n5. Pre-op IIEF-5 \\>20 (Appendix A)\n6. Testosterone serum: \\> 300ng\u002Fdl with normal Free Testosterone\n7. Life expectancy of at least 10 years\n8. Performance status of ≤ 2 (Zubrod scale). (Appendix B)\n9. Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution\n10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery\n11. Supportive partner willing to complete sexual survey questionnaire (Appendix D)\n12. PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery.\n13. Patient need cardiac clearance by the cardiologist\n\nExclusion Criteria:\n\n1. Penile anatomical abnormalities (Peyronie's disease)\n2. Hypogonadism\n3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)\n4. Patients with AST levels above 40U\u002FL ; ALT levels above 33 U\u002FL and Glucose levels above 180 mg\u002Fdl and psychiatric disorders that require medication\n5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.\n6. Any previous penile implant or penile vascular surgery\n7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .\n\n   \\-","MALE",{"count":157,"type":22},[25,26],"This is a phase 1\u002F2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.",[541,542],"Erectile Dysfunction","Prostate Cancer","2026-03-16",{"date":545,"type":40},"2026-03-19",{"date":547,"type":22},"2026-03-10",{"date":549,"type":22},"2027-06-30",{"name":46,"class":47},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":557,"targetDuration":559,"studyType":332,"phases":4,"briefSummary":560,"conditions":561,"keywords":563,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":569,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":48},"100576192","mri-guided-management-of-occlusive-peripheral-arterial-disease-100576192","NCT06782100","MRI Guided Management of Occlusive Peripheral Arterial Disease","Inclusion Criteria:\n\nA. General Inclusion Criteria:\n\ni. All patients will be ≥ 18 years old with PAD (Rutherford Category 4, 5, 6)\n\nB. Anatomic inclusion criteria:\n\ni. At least 1 target lesion below-the-knee in native vessels in one or both limbs ii. Target lesion reference vessel diameter between 2.0 - 4.0 mm by investigator visual estimate iii. Target lesion with \\> 50% stenosis by investigator visual estimate\n\nExclusion Criteria:\n\nA. General Exclusion Criteria:\n\ni. Rutherford category 0, 1, 2, 3 of target limb, Failure or refusal to provide written informed consent, MRI Contraindications\n\nB. Anatomic Exclusion Criteria:\n\nii. Aim 2 only - Chronic total occlusions",{"count":558,"type":22},175,"12 Months","The goal of this observational study is to identify which plaque lesions in patients with peripheral arterial disease are impenetrable and to determine which devices minimize vessel wall injury.\n\nPatients undergoing intervention will have an MRI scan prior to their planned percutaneous vascular intervention to assess the plaque and predict procedural difficulty.\n\nPatients undergoing lower limb amputation due to peripheral arterial disease will have their limbs included into a second arm of the study The limb will undergo an MRI scan to assess the plaque. The investigator will then test two different devices and assess the effects of these devices on the vessel wall.",[562],"Peripheral Vascular Diseases",[555,564,565,566,567,568],"PAD","Peripheral Vascular Disease","PVI","MRI","MRA",{"date":545,"type":40},{"date":571,"type":40},"2024-07-01",{"date":573,"type":22},"2029-06",{"name":46,"class":47},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":82,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":23,"phases":584,"briefSummary":585,"conditions":586,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":48},"100596845","phase-2-comprehensive-multimodal-prehabilitation-alone-or-with-neoadjuvant-therapy-before-major-cancer-surgery-100596845","NCT07050771","Comprehensive Multimodal Prehabilitation Alone or With Neoadjuvant Therapy Before Major Cancer Surgery","Comprehensive Multimodal Prehabilitation Alone or in Combination With Planned Neoadjuvant Therapy in High-risk Patients Prior to Elective Major Cancer Surgery","Inclusion Criteria:\n\nPatients are eligible for entry into the study (First Registration) only if ALL of the following criteria apply. No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.\n\n* Signed informed consent form.\n* Age ≥18 years at time of signing informed consent form.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 per the treating cancer surgeon (Arm 1, Neoadjuvant therapy) or per both the treating cancer surgeon and the medical and\u002For radiation oncologists (Arm 2, no neoadjuvant therapy).\n* Pre-frail or frail (based on the Fried Frailty Phenotype\n* Probable or proven (histologically confirmed) pancreaticobiliary\u002Fperiampullary (i.e., pancreatic cancer, cholangiocarcinoma, duodenal cancer, or ampullary cancer), ovarian cancer, kidney cancer, or bladder cancer based on central pathological review at Houston Methodist Hospital.\n* Clinically non-metastatic (stage I-III) or metastatic (IV) disease.\n* Technically resectable disease (no significant vascular, neural, or bony involvement and potential to safely achieve R0 resection) and potentially medically fit for EMCS per the treating cancer surgeon (surgical oncologist\u002FHBP surgeon, gynecologic oncologist, or urologic oncologist).\n* Tentatively scheduled to undergo elective pancreatectomy (open or minimally invasive pancreaticoduodenectomy or open distal pancreatectomy) for pancreaticobiliary\u002Fperiampullary cancer, elective surgical cytoreduction for ovarian cancer, elective open radical nephrectomy for kidney cancer, or elective (open or minimally invasive) total cystectomy for bladder cancer by one of the study MPI or Co-Is \\> 28 days after trial registration.\n* Neoadjuvant therapy group only: Completed planned NAT (if any) at least 2 weeks prior to Study Registration.\n* No neoadjuvant therapy group only: Medically fit and planned to receive NAT per the treating medical and\u002For radiation oncologist.\n* Ability to comply with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.\n* Willing and able to consume a lactose-free, whey protein supplement (if not allergic to milk protein\u002Fsoy and no history of galactosemia), marine protein supplement (if not allergic to marine protein\u002Fshellfish), or pea protein supplement (if not allergic to pea protein).\n* Willing to provide tissue and blood specimens as per protocol.\n* For patients receiving therapeutic anticoagulation: stable anticoagulant regimen.\n* Access to a smart phone (personally or via caretaker who resides with the patient).\n* Understands, speaks, and reads English.\n\nExclusion Criteria:\n\nPatients are NOT eligible for entry into the study (First Registration) only ANY of the following criteria apply. No exceptions or waivers will be granted for patients who do not meet the eligibility criteria.\n\n* Difficulty or inability to hear and\u002For understand loud speech and sounds.\n* Unable to eat by mouth (e.g., tube feed dependent, on total parenteral nutrition, etc.)\n* Oxygen dependent (or rest and\u002For with exertion).\n* Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification III or IV, unstable angina, unstable arrhythmia, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of trial treatment.\n* Dependence on mobility device for ambulation other than a cane (e.g., crutches, walker, wheelchair).\n* Active brain metastasis or leptomeningeal disease.\n* Active bone metastasis and\u002For recent bone fracture.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). NOTE: Patients with indwelling catheters (e.g., PleurX) are allowed\n* Planned receipt of investigational therapy\u002Ftreatment (other than the protocol-mandated CMMP intervention) during the trial treatment.\n* Major procedure\u002Fsurgery within 12 weeks prior to initiation of trial treatment that would prevent the patient from complying with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.\n* Active physical\u002Fmental condition or personal\u002Fsocial circumstance that would prevent the patient from complying with the CMMP intervention and study assessments as per protocol, in the MPI's judgment.",{"count":583,"type":22},148,[26],"In this 2-arm, non-randomized, phase II trial, the investigators will evaluate the efficacy and safety of comprehensive multimodal prehabilitation (CMMP) alone or in combination with planned neoadjuvant (NAT) in pre-frail\u002Ffrail patients with probable\u002Fproven pancreaticobiliary, ovarian, kidney, or bladder cancer prior to elective major cancer surgery (EMCS).",[587,588,589,590],"Hepatopancreaticobiliary (HPB) Malignancy","Ovarian Cancer (OvCa)","Kidney Cancers","Bladder Cancer",{"date":592,"type":40},"2026-03-12",{"date":594,"type":40},"2025-08-14",{"date":596,"type":22},"2027-10-01",{"name":46,"class":47},""]