[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Vermont Medical Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":428},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,49,78,105,130,153,174,200,234,257,276,301,330,379,403],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100592815","phase-2-mohs-surgery-and-short-course-radiation-therapy-with-structured-follow-up-for-head--neck-squamous-cell-skin-cancer-100592815",false,"NCT06998342","MOHs Surgery and Short-Course Radiation Therapy With Structured Follow-Up for Head & Neck Squamous Cell Skin Cancer","MOHs Surgery and Adjuvant Short-course Hypofractionated Radiation Therapy With Structured Surveillance for Cutaneous Head & Neck Squamous Cell Carcinoma: a Phase II Pilot Study (MOHSAHRTSS-Study)","MOHSAHRTSS","Inclusion Criteria:\n\n* Pathologically confirmed cutaneous squamous cell carcinoma of the head \\& neck region, defined as extending from vertex of head to supraclavicular region.\n* Mohs micrographic surgery with or without further surgery following Mohs to achieve negative margins (i.e. R0 margin status) within 70 days prior to registration\n* Appropriate stage for study entry (T1-T3 N0 M0; AJCC 8th ed.) based on the following diagnostic workup:\n\n  * Clinical exam within 60 days prior to registration\n  * CT head \\& neck\u002Fsoft tissue with IV contrast within 60 days prior to registration or MR face and neck with IV contrast. IV contrast may be held if medically contraindicated.\n  * Bilateral neck ultrasound within 60 days prior to registration\n* Risk Factors fitting either the High-Risk or Moderate-Risk Categories:\n\n  * Risk Factor Definitions\n\nMajor Risk Factors: Microscopic Extensive PNI (defined as PNI for \\>3 nerves with all involved nerves either \\>0.1 mm in size and\u002For deeper than the dermis), Gross PNI (defined as perineural spread evidenced on by MRI imaging, with cranial nerve deficit, or both), Size \\>6 cm, or Recurrent disease status post prior Mohs\n\nModerate-Risk Factors: Poor differentiation, 4-6 cm, PNI (defined as \\>0.1 mm in size)\n\nBWH Risk factors: \\>2 cm, poor differentiation, deep invasion, PNI (\\>0.1 mm in size)\n\n• BWH: T2a = 1 risk factor; T2b = 2-3 risk factors, T3 = 4 risk factors\n\nHigh-Risk Group (Group H) Any 1 major OR 2-3 moderate OR BWH T3\n\nModerate-Risk Group (Group M) BWH T2b not meeting criteria for High-Risk.\n\nExclusion Criteria:\n\n* Patients receiving any other investigational agents.\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\nSerious medical comorbidities that, in the opinion of the radiation oncologist, would prevent participation in this study.\n\nPrior systemic chemotherapy for the study cancer; note that prior chemotherapy for different cancer(s) is allowable\n\nPrior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n\nActively receiving systemic cytotoxic chemotherapy, immunosuppressive, anti-monocyte or immunomodulatory therapy.","ALL","18 Years",{"count":20,"type":21},24,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate if short-course radiation therapy (SCRT) can effectively treat high-risk cutaneous squamous cell carcinoma (cSCC) and if active surveillance is a safe alternative to radiation for moderate-risk cSCC in adults with head and neck cSCC who have undergone surgery.\n\nThe main questions it aims to answer are:\n\nDoes short-course radiation therapy (5 treatments over 2 weeks) effectively prevent cancer recurrence in high-risk patients? Can moderate-risk patients be safely monitored with active surveillance instead of receiving radiation?\n\nResearchers will compare:\n\nShort-course radiation therapy (SCRT) for high-risk patients to historical data on long-course radiation to determine effectiveness.\n\nActive surveillance for moderate-risk patients to expected recurrence rates to assess safety.\n\nParticipants will:\n\nHigh-Risk Group (SCRT): Receive short-course radiation therapy and attend follow-up visits.\n\nModerate-Risk Group (Active Surveillance): Have regular check-ups, including clinical exams and imaging, to monitor for cancer recurrence.\n\nOptionally provide blood samples for future biomarker research.",[27],"Cutaneous Squamous Cell Carcinoma (CSCC)",[29,30,31,32,33,34,35],"Cutaneous Squamous Cell Carcinoma","Head and Neck Cancer","Neoadjuvant Therapy","Immunotherapy","Surgical Oncology","Clinical Trial","Radiation","RECRUITING","2026-05-20",{"date":39,"type":40},"2026-05-26","ACTUAL",{"date":42,"type":40},"2025-06-04",{"date":44,"type":21},"2031-05",{"name":46,"class":47},"University of Vermont Medical Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":48},"100590972","phase-2-avoiding-radiation-therapy-due-to-intracranial-response-to-chemotherapy-targeted-therapy-andor-immuno-oncology-therapy-for-brain-metastases-pilot-pragmatic-trial-100590972","NCT06974370","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial","Avoiding Radiation Therapy Due to Intracranial Response to Chemotherapy, Targeted Therapy and\u002For Immuno-ONcology Therapy for Brain Metastases: Pilot Pragmatic Trial (ACTION-Brain Metastases: Pilot Pragmatic Trial)","ACTION-Brain","Inclusion Criteria:\n\nPathologically (histologically or cytologically) proven diagnosis of a solid tumor malignancies within 5 years prior to registration. If the original histologic proof of malignancy is greater than 5 years, then more recent pathologic confirmation (e.g., from a systemic site or brain metastasis) or unequivocal imaging confirmation of extracranial metastatic disease (e.g. CT of the chest\u002Fabdomen\u002Fpelvis, PET\u002FCT, etc.) is required. These scans are considered standard-of-care (SOC) and will not be ordered for research purposes.\n\nInitiation or planning for initiation of systemic therapy to include one or more of the following categories expected to cause an intracranial response:\n\n* Brain penetrant targeted therapies (e.g. tyrosine kinase inhibitors, multikinase inhibitors, EGFR inhibitor, ALK inhibitor, BRAF\u002FMEK inhibitor)\n* Checkpoint inhibitor immunotherapy (e.g. PDL-1 inhibitors, PD1 inhibitors, CTLA-4 inhibitors)\n* HER2 antibody-drug conjugate (e.g. TDM1, TDX-D)\n* Anti-Hormone therapies for Breast Cancer\n* Cytotoxic chemotherapy alone may be started initially, but with plan for immunotherapy or eligible targeted therapy noted above before the re-evaluation MRI head\n\nAt least 1 brain metastasis that not planned for radiation therapy or surgery.\n\nAll brain metastases not planned for resection much be ≤3 cm, with no minimum size required.\n\nSystemic therapy has started within 4 weeks of MRI brain showing new or progressive disease or plan to start systemic therapy within 4 weeks of MRI brain showing new or progressive disease.\n\nAbility to obtain MRI head scans with contrast. All MRI head scans must have slice thickness ≤1.5 mm.\n\nAge ≥ 18 years\n\nKPS \\>60\n\nAbility to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nNo use of the planned new systemic therapy meeting 2.1.2 criteria to address brain metastases within the last 6 months.\n\nPrior radiotherapy to the active brain metastases (partial or whole brain irradiation, or prophylactic cranial irradiation \\[PCI\\])\n\nPatients pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. Negative urine pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n\nSerious medical comorbidities that in the opinion of the investigator would prevent participation in this study.\n\nKnown leptomeningeal disease (LMD)\n\n\\-",{"count":58,"type":21},45,[24],"This pilot pragmatic trial evaluates the feasibility of avoiding radiation therapy in patients with brain metastases who demonstrate an intracranial response to systemic therapy-including immunotherapy, targeted therapy, and\u002For chemotherapy. The study will prospectively enroll 45 patients, divided into two cohorts: 30 with non-small cell lung cancer (NSCLC) receiving immunotherapy, and 15 with brain metastases from other solid tumors. Eligible participants must have at least one brain metastasis not planned for radiation or surgery and must be initiating or planning to initiate a systemic therapy regimen expected to penetrate the blood-brain barrier and achieve intracranial activity.\n\nAll patients will undergo a re-evaluation brain MRI 4-8 weeks after initiating systemic therapy. If lesions are stable or regressing, patients will continue surveillance without radiation. If progression is noted, standard-of-care radiation may be administered at the discretion of the treating physician. The primary objective is to assess 6-month radiation therapy-free survival (RTFS) in NSCLC patients based on PD-L1 expression status. Secondary endpoints include intracranial progression-free survival, overall survival, radiation necrosis rate, and quality of life. This study seeks to inform future trial design and identify patients who may safely avoid brain radiation.",[62,63],"Brain Metastases, Adult","Brain Metastases From Non-small Cell Lung Cancer (NSCLC)",[65,66,67,68,69,70,71],"Brain Metastases","Radiation Therapy","NSCLC","Quality of Life","FACT-Br","NANO Scale","Pragmatic Trial",{"date":39,"type":40},{"date":74,"type":40},"2025-06-05",{"date":76,"type":21},"2030-12",{"name":46,"class":47},{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":4},"100636454","gardening-for-health-for-cancer-survivors-100636454","NCT07565896","Gardening for Health for Cancer Survivors","Gardening for Health for Cancer Survivors (G4H-CS)","G4H-CS","Inclusion Criteria:\n\n* Age 18 years or older\n* Self-reported current or prior diagnosis of cancer\n* Self-identifies as a cancer survivor\n* Ability to read, write, and speak English\n\nExclusion Criteria:\n\n* Currently significantly immunosuppressed",{"count":5,"type":21},[88],"NA","This study is testing whether a gardening and nutrition program can improve well-being in people who have had cancer. Many cancer survivors continue to experience challenges after treatment, including changes in appetite, nutrition, stress, and quality of life. Programs that combine healthy eating, physical activity, and social connection may help address these issues.\n\nIn this study, participants will take part in a 6-week, in-person program called Gardening for Health. The program includes weekly group sessions held at a garden at the University of Vermont Medical Center. Each session lasts about two hours and includes hands-on gardening activities, nutrition education, cooking demonstrations, and guided wellness practices such as mindfulness and light movement. Participants will also receive educational materials to support healthy eating and gardening at home.\n\nThe main goal of the study is to determine whether this program is feasible and acceptable for cancer survivors, meaning whether people are willing to participate, attend sessions, and find the program helpful and satisfying. The study will also explore whether participation is associated with improvements in quality of life, stress, sense of belonging, and nutrition-related behaviours.\n\nParticipants will complete questionnaires before starting the program and again after the 6-week program ends. These surveys will ask about overall health, stress levels, social connection, and lifestyle habits.\n\nThe researchers hypothesize that participation in the Gardening for Health program will be feasible and well-received by cancer survivors, and that it may lead to improvements in quality of life, reduced stress, and increased feelings of connection and well-being.\n\nThis is a single-group study, all participants receive the intervention and there is no comparison group. The results will help determine whether this type of program should be studied further in larger trials.",[68,91],"Lifestyle Intervention",[93,94,95],"Cancer Survivors","Gardening Therapy","Horticultural Therapy","NOT_YET_RECRUITING","2026-04-29",{"date":99,"type":40},"2026-05-04",{"date":101,"type":21},"2028-07",{"date":103,"type":21},"2042-07",{"name":46,"class":47},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":48},"100494828","care-coordination-educational-intervention-study-for-patients-from-rural-areas-with-early-stage-cancer-100494828","NCT05723250","Care Coordination Educational Intervention Study for Patients From Rural Areas With Early Stage Cancer","Patient-Centered Video Education Intervention to Improve Rural Cancer Care Delivery in Vermont: A Feasibility Study","Inclusion Criteria:\n\n* 18+ years of age\n* Breast, lung, or colon cancer diagnosis\n* Stage I, II or III cancer\n* Adjuvant chemotherapy started \\\u003C 30 days or planned within the next 30 days\n* Rural residence location in Vermont (outside Chittenden County)\n* Proficient in English\n\nExclusion Criteria:\n\n* History of prior malignancy treated with chemotherapy in last 3 years\n* Known or suspected neuro-cognitive impairment\n* Resident of Chittenden County, Vermont\n* Patients with current diagnosis other than stage I, II or III breast, colon or lung cancer",{"count":113,"type":21},40,[88],"Care Coordination is an essential component of cancer care delivery. Many patients experience poor care coordination. In this study, we hypothesize that provision of a video educational intervention to teach patients about cancer, care coordination and self-advocacy will improve patients' perception of care coordination. Cancer patients with early stage disease scheduled to receive adjuvant therapy, and who reside in a rural area, will be enrolled onto the study. Patients will be randomized to receive a table-based educational intervention tool initially (arm1) or after 4 months of therapy (arm2). Assessment of cancer knowledge, self-advocacy and care coordination will be obtained at baseline and after 4-6 months.",[117],"Cancer",[119,120,121,122],"healthcare delivery","care coordination","early stage cancer","educational intervention","2026-04-27",{"date":99,"type":40},{"date":126,"type":40},"2023-03-31",{"date":128,"type":21},"2028-01-31",{"name":46,"class":47},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100633649","feasibility-and-expansion-trial-of-transcutaneous-vagus-nerve-stimulation-tvns-for-immune-related-fatigue-in-patients-receiving-immune-checkpoint-inhibitors-100633649","NCT07529431","Feasibility and Expansion Trial of Transcutaneous Vagus Nerve Stimulation (tVNS) for Immune-Related Fatigue in Patients Receiving Immune Checkpoint Inhibitors","Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically confirmed advanced or metastatic solid tumor\n* Receiving immune checkpoint inhibitor therapy and completed at least two cycles\n* Clinically significant fatigue (FACIT-F score ≤ 34)\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months\n* Ability to provide informed consent\n* Access to a smartphone or tablet\n\nExclusion Criteria:\n\n* Current or planned chemotherapy, targeted therapy, or radiation during the 4-week intervention period.\n* Have received targeted therapy in the last 2 weeks\n* Have received chemotherapy or radiation therapy in the last 4 weeks\n* Symptomatic brain metastases defined as active neurologic complaint (headache, blurry vision, neurologic deficits or other symptom requiring treatment with steroids)\n* Long term steroid use \\>10 mg prednisone equivalent daily\n* Active autoimmune disease requiring systemic immunosuppression\n* Implanted electronic medical devices (e.g., pacemakers, defibrillators)\n* History of epilepsy or vagal hypersensitivity\n* Known arrhythmia or bradycardia (Baseline HR \\\u003C 50 bpm)\n* Open wounds or dermatologic issues at the stimulation site\n* Pregnancy or breastfeeding\n* Participation in other fatigue-focused intervention trials\n* Severe uncontrolled psychiatric illness (PHQ-9 \\>20)",{"count":137,"type":21},13,[88],"This study evaluates whether a non-invasive device called transcutaneous vagus nerve stimulation (tVNS) can be safely and feasibly used to help reduce fatigue in patients receiving immunotherapy for cancer. Fatigue is a common and often severe side effect of immune checkpoint inhibitors, and there are currently limited effective treatment options.\n\nIn this study, participants will use a small device at home that delivers mild electrical stimulation to the ear for 60 minutes each day over a 6-week period. The study will assess whether patients are able to use the device as prescribed (feasibility), how well it is tolerated, and whether it may improve fatigue and quality of life.\n\nThe study will also explore changes in biological markers of inflammation and measures of nervous system function to better understand how tVNS may work. The results of this study will help determine whether this approach should be tested in larger future trials.",[141],"Cancer-related Fatigue",[143,144],"Cancer-related fatigue","Vagus nerve stimulation","2026-04-07",{"date":147,"type":40},"2026-04-14",{"date":149,"type":21},"2026-07-01",{"date":151,"type":21},"2035-07",{"name":46,"class":47},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":48},"100485641","phase-2-pyridostigmine-for-the-treatment-of-constipation-in-parkinson-disease-100485641","NCT05603715","Pyridostigmine for the Treatment of Constipation in Parkinson Disease","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Be able to provide signed informed consent\n3. Stated ability and willingness to comply with all study procedures\n4. Able to take oral medications\n5. Females of reproductive potential who are sexually active must be willing to use two of the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (female condom, diaphragm, cervical cap with\u002Fwithout spermicide), hormonal contraception, or intrauterine device; OR one of the previously mentioned methods AND partner must use barrier contraception (male condom with\u002Fwithout spermicide)\n6. Males of reproductive potential who are sexually active must be willing to use the following highly effective methods of contraception for the duration of study participation and for an additional 28 days after the end of study drug administration: barrier contraception (male condom with\u002Fwithout spermicide) AND partner must be postmenopausal, use hormonal contraception, have an intrauterine device, or use barrier contraception (female condom, diaphragm, cervical cap with\u002Fwithout spermicide)\n7. Meet United Kingdom Parkinson's Disease Society Brain Bank Criteria:\n\n   A. Diagnosis of a parkinsonism:\n   * Bradykinesia, plus at least one of the following:\n   * Muscular rigidity\n   * 4-6 Hz resting tremor\n   * Postural stability not caused by primary visual, vestibular, cerebellar or proprioceptive dysfunction\n\n   B. At least three supportive criteria:\n   * Unilateral onset of symptoms\n   * Rest tremor\n   * Progressive symptoms\n   * Persistent asymmetry affecting the side of onset most\n   * Excellent response to levodopa\n   * Severe levodopa-induced chorea\n   * Levodopa response for five years or more\n   * Clinical course of 10 years or more\n8. Fulfill the ROME IV Criteria for Functional Constipation, with a specific requirement that the patient must have three or fewer defecations per week (criterion Ai):\n\n   * Must include two or more of the following:\n\n     i. Three or fewer defecations per week ii. Straining during \\> 25% of defecations iii. Lumpy or hard stools in \\> 25% of defecations iv. Sensation of incomplete evacuation for \\> 25% of defecations v. Sensation of anorectal obstruction\u002Fblockage for \\> 25% of defecations vi. Manual maneuvers to facilitate \\> 25% of defecations\n   * Loose stools are rarely present without the use of laxatives\n   * Insufficient criteria for irritable bowel syndrome\n   * Criteria 1-3 must be fulfilled for at least three months with onset of symptoms at least six months prior to diagnosis\n\nExclusion Criteria:\n\n1. Diagnosis of atypical parkinsonism\n2. Diagnosis of drug-induced parkinsonism\n3. Diagnosis of vascular parkinsonism\n4. Known allergy to pyridostigmine bromide or other study drug components\n5. Current or recent (within 90 days of enrollment) use of pyridostigmine for any reason\n6. History of any bowel surgery\n7. History of bladder or bowel obstruction\n8. Severe asthma or chronic obstructive pulmonary disease\n9. Meet exclusion criteria noted in the UK Parkinson's Disease Society Brain Bank Criteria, at the PI's discretion:\n\n   A.Exclusion of any of the following:\n   * Repeated strokes with stepwise progression of parkinsonian features\n   * Repeated head injury\n   * Definite encephalitis\n   * Oculogyric crises\n   * Neuroleptic treatment at onset of symptoms\n   * Greater than one affected relative\n   * Sustained remission\n   * Strictly unilateral features after 3 years\n   * Supranuclear gaze palsy\n   * Cerebellar signs\n   * Early severe autonomic involvement\n   * Early severe dementia\n   * Babinski sign\n   * Cerebral tumor or communicating hydrocephalus\n   * Negative response to large doses of levodopa\n   * 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine exposure\n10. Significant abnormalities on laboratory analysis (complete blood count, comprehensive metabolic panel, thyroid stimulating hormone) conducted at the screening visit or within the three months prior if available for review\n11. Significant abnormalities on screening electrocardiogram conducted at the screening visit or within the three months prior if available for review\n12. Positive pregnancy test (if female of child-bearing age)\n13. Antibiotic use within two weeks prior to enrollment",{"count":160,"type":21},16,[24],"Constipation is a common and debilitating non-motor symptom of Parkinson disease (PD) that often precedes the onset of classic motor symptoms by decades. There is no standardized algorithm for managing constipation in this patient population, nor are there dedicated treatments. Studies suggest that constipation can affect quality of life to a significant degree, in many cases just as much as motor symptoms. There is an unmet need for effective treatment options for constipation in this patient population. The goal of this study is to determine the efficacy and safety of pyridostigmine as a treatment for chronic constipation in patients with PD.",[164,165],"Parkinson Disease","Constipation","2026-02-20",{"date":168,"type":40},"2026-02-23",{"date":170,"type":40},"2022-08-10",{"date":172,"type":21},"2026-12-31",{"name":46,"class":47},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":182,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":48},"100624204","gut-microbiome-changes-during-abemaciclib-therapy-in-breast-cancer-100624204","NCT07406594","Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer","MICRO-VERZ: MICRObiome Changes During VERZenio Therapy","MICRO-VERZ","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.\n* Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\n  * Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.\n* Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.\n* Known allergy or intolerance to resistant starch or any component of the study supplement.\n* Pregnant or breastfeeding individuals.\n* Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.","FEMALE",{"count":184,"type":21},12,[88],"Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms.\n\nThe purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely.\n\nInformation gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.",[188,189],"Breast Cancer","HER-2 Positive Breast Cancer",[191],"microbiome","2026-02-05",{"date":194,"type":40},"2026-02-12",{"date":196,"type":21},"2027-10",{"date":198,"type":21},"2031-10",{"name":46,"class":47},{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":218,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":48},"100598506","nutritional-prehabilitation-to-improve-cancer-outcomes-n-pico-100598506","NCT07072377","Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)","N-PICO","Inclusion Criteria:\n\n* Diagnosis of invasive cancer with plans to initiate chemo-, immune-, targeted-, or hormonal therapy for treatment of their malignancy, or within one month of starting treatment.\n* Age ≥ 18 years of age.\n* Patients must be able to read, write, and speak English as study material and virtual nutrition consultation calls are only available in English.\n* Patients receiving treatment at a participating ambulatory medical oncology site.\n* Willingness to have a remote nutritional consultation and complete questionnaires\u002Fsurveys.\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.\n\nExclusion Criteria:\n\n* Diagnosis of acute leukemia (these patients generally receive predominantly inpatient care).\n* Diagnosis of head \\& neck cancer, esophageal cancer, gastric cancer, patients presenting with recognized cachexia or severe malnutrition, or patients with PEG tubes for enteral feeding.\n\nRationale: These patients would normally be referred for dietary consultation and may need ongoing clinical intervention from an on-site dietitian beyond the period of the proposed study",{"count":208,"type":21},240,[88],"Brief Summary\n\nThe goal of this clinical trial is to evaluate the acceptability and adherence of low- and high-intensity remote nutritional interventions for cancer patients in rural and urban areas, specifically focusing on those with invasive cancer who are about to start treatment. The main question\\[s\\] it aims to answer are:\n\nCan low- and high-intensity remote nutritional interventions improve adherence to cancer treatment and quality of life? What is the impact of nutritional support on treatment delays, unplanned healthcare utilization, and dietary modifications? Researchers will compare the low-intensity arm (initial nutritional consultation plus written materials) to the high-intensity arm (1-hour consultation, monthly follow-ups, and written materials) to see if higher intensity interventions lead to better outcomes in terms of adherence, quality of life, and healthcare utilization.\n\nParticipants will:\n\nReceive either a low- or high-intensity nutritional consultation. Complete surveys assessing quality of life, dietary habits, treatment delays, and unplanned healthcare use.\n\nBe asked to participate in monthly follow-up consultations (for the high-intensity group) to track progress and provide additional support.",[212,213,214,215,216,217],"Malnutrition","Cancer-related Malnutrition","Quality of Life (QOL)","Nutritional Support","Nutritional Interventions","Rural Health",[219,220,221,222,223,224,225,226],"Cancer Nutrition Intervention","Malnutrition in Cancer Patients","Nutritional Support for Cancer","Prehabilitation Program for Cancer","Rural Cancer Nutrition","Quality of Life and Cancer Nutrition","Remote Nutritional Consultations","Cancer Treatment Outcomes and Nutrition","2026-02-02",{"date":192,"type":40},{"date":230,"type":40},"2025-09-10",{"date":232,"type":21},"2028-09",{"name":46,"class":47},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":48},"100575909","phase-2-hybrid-arc-palliative-radiation-therapy-hart-a-single-arm-phase-ii-trial-100575909","NCT06778408","Hybrid Arc Palliative Radiation Therapy (HART): A Single Arm Phase II Trial","HART","Inclusion Criteria:\n\nHistological confirmation of cancer with radiographic (CT, MRI or PET) evidence of metastatic disease\n\nPalliative radiotherapy indicated for bone or soft tissue metastases, or primary targets, located in the thorax, abdomen, or pelvis as part of their standard of care treatment plan\n\nAge ≥ 18 years.\n\nWomen of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nIn lieu of a pregnancy test, participants may sign the Pregnancy Attestation Form, a standard form routinely used in clinical practice at UVMCC.\n\nRecommended methods of birth control are:\n\nThe consistent use of an approved hormonal contraception (birth control pill\u002Fpatches, rings), An intrauterine device (IUD), Contraceptive injection (Depo-Provera), Double barrier methods (Diaphragm with spermicidal gel or condoms with contraceptive foam), Sexual abstinence (no sexual intercourse) or Sterilization.\n\nMen must agree to use a condom and not father a child or donate sperm for the duration of the study and for 90 days after completion of therapy.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nAbility to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\nPatients receiving any other investigational agents or concurrent cytotoxic chemotherapy\n\nPatients who are pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\nSerious medical comorbidities, which in the opinion of the radiation oncologist preclude the delivery of RT",{"count":242,"type":21},103,[24],"This is a prospective single-center single-arm Phase II trial of HART for patients with metastatic cancer. The primary objective is to assess the incidence of acute GI toxicity following HART. PRO-CTCAE GI scores observed in the study patients will be compared to historical rates. Secondary outcomes include measuring changes in health-related quality of life, esophageal quality of life, toxicity, dosimetric outcomes, and pain.",[246,247],"Palliative Radiotherapy","Metastatic Cancer (Different Solid Tumour Types)",[249,250],"palliative","radiotherapy",{"date":192,"type":40},{"date":253,"type":40},"2025-04-28",{"date":255,"type":21},"2028-03",{"name":46,"class":47},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":48},"100537628","multi-disciplinary-care-for-brain-metastases-100537628","NCT06280300","Multi-disciplinary Care for Brain Metastases","Intensive Multi-Disciplinary Care Initiative for Patients With Newly Diagnosed Brain Metastases","Inclusion Criteria:\n\n* Patients of all genders must be at least 18 years of age.\n* Patients must have histologically confirmed, newly diagnosed brain metastases from known or suspected solid tumor primary neoplasms.\n* Patients must be able to accurately provide self-report data (e.g. per clinical judgment, cognitive function is intact).\n* Patients must be able to complete questionnaires in English.\n* Patients must have the ability to provide informed consent.\n\nExclusion Criteria:\n\n* Patients who are \\\u003C 18 years of age are not eligible.\n* Patients who are Pregnant are not eligible.",{"count":113,"type":21},[88],"This is a health services intervention study aimed at understanding the impact of intensive multi-disciplinary care compared with standard care on patient-reported symptom outcomes and prognostic awareness in patients with brain metastases.",[62],"2026-01-27",{"date":270,"type":40},"2026-01-29",{"date":272,"type":40},"2023-11-16",{"date":274,"type":21},"2027-07-01",{"name":46,"class":47},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":290,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":48},"100491797","phase-2-venous-thromboembolism-prevention-in-outpatients-with-glioma-100491797","NCT05683808","Venous Thromboembolism Prevention in Outpatients With Glioma","VTE-POG","Inclusion Criteria:\n\n* Histologic diagnosis of malignant glioma, World Health Organization (WHO) grade 4, including glioblastoma and astrocytoma, based on recent biopsy or resection.\n* Age 18 and old\n* Karnofsky performance status (KPS) 60-100\n* Acceptable labs, including platelets of greater than or equal to 100,000, glomerular filtration rate (GFR) greater than or equal to 25.\n* Ability to provide informed consent.\n* Planning for treatment with radiation and chemotherapy.\n\nExclusion Criteria:\n\n* Evidence of deep venous thrombosis (DVT), pulmonary embolism (PE), or cerebral vein thrombosis (CVT) within 6 months prior to enrollment on the study.\n* Pregnancy.\n* Significant bleeding risk including: history of symptomatic intracranial hemorrhage, active bleeding at time of study registration, clinically significant bleeding within 14 days of study registration, intracranial trauma in the past 6 months, including stroke or traumatic brain injury, major surgery or major procedure within 48 hours.\n* Allergy to apixaban or contraindication to prophylactic anticoagulation. Contraindications include patients who are currently on unfractionated heparin, low molecular weight heparin, heparin derivatives (examples: fondaparinux), or other direct oral anticoagulants (examples: dabigatran, edoxaban, rivaroxaban), who are either unable or unable to discontinue these agents in favor of the investigational drug. Apixaban is also contraindicated in patients who are on strong CYP3A4 inhibitor and P-glycoprotein inhibitors.\n* Indication for full anticoagulation (i.e. atrial fibrillation, mechanical valve, etc.).\n* Estimated life expectancy of \\\u003C3 months.",{"count":113,"type":21},[24],"This is an open label study of apixaban for venous thromboembolism prevention in patients with newly diagnosed grade 4 glioma.",[287,288,289],"Glioblastoma","Astrocytoma","Venous Thromboembolism",[291,287,288,292,293],"High grade glioma","Venous thromboembolism","Apixaban",{"date":295,"type":40},"2026-01-30",{"date":297,"type":40},"2023-01-16",{"date":299,"type":21},"2027-06-30",{"name":46,"class":47},{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":308,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":48},"100589223","optimizing-aerobic-fitness-in-older-adults-100589223","NCT06951620","Optimizing Aerobic Fitness in Older Adults","Optimizing Aerobic Fitness and Functional Response to Exercise in Older Adults","Inclusion Criteria:\n\n* \\>65 years old\n* ambulatory\n* enrolled in CR at our center following a recent clinical diagnosis of myocardial infarction or percutaneous intervention will be recruited\n\nExclusion Criteria:\n\n* have an active malignancy (excluding non-melanoma skin cancer or low grade prostate cancer under surveillance)\n* unwilling to comply with the exercise prescription they may be assigned to\n* have a submaximal performance on entry exercise tolerance test, defined as respiratory exchange ratio \\\u003C1.0","65 Years",{"count":310,"type":21},114,[88],"Hospitalization and treatment for cardiovascular disease is one of the main contributors to disability in older adults. Moderate intensity continuous aerobic and resistance training have been the cornerstone of cardiac rehabilitation (CR) for decades to remediate hospital-acquired functional deficits, but some groups receive less or minimal functional benefit from this training. The proposed studies seek to optimize recovery of aerobic fitness and physical function among older cardiac patients using a novel high intensity training regimen with the long-term goal of reducing subsequent disability and improving clinical outcomes.",[314,315],"Aerobic Capacity","High Intensity Interval Training",[317,318,319,320,321],"cardiac rehabilitation","HIIT","MICT","exercise in older adults","aerobic capacity","2025-06-06",{"date":324,"type":40},"2025-06-08",{"date":326,"type":40},"2025-04-17",{"date":328,"type":21},"2029-06-30",{"name":46,"class":47},{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":337,"sex":17,"minAge":338,"maxAge":308,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":352,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":48},"100578956","avocado-and-postprandial-responses-100578956","NCT06818032","Avocado and Postprandial Responses","Acute Avocado Consumption on Postprandial Glycemic and Appetite\u002FSatiety Responses","Inclusion Criteria:\n\n* Biological sex males or females\n* Age 21 to 65 years\n* BMI between 18.5 and 34.9 kg\u002Fm2\n\nExclusion Criteria:\n\n* Actively pregnant or lactating women\n* Diagnosis of prediabetes or diabetes (fasting glucose \\>100 mg\u002FdL)\n* Current diagnosis of uncontrolled hypertension (systolic BP: \\>160 mmHg, diastolic BP: \\>95 mmHg), may receive treatment for hypertension as long as on a stable regimen for the previous one month\n* Current diagnosis of uncontrolled hyperlipidemia (fasting total blood cholesterol \\>200 mg\u002FdL, fasting triglycerides \\>200 mg\u002FdL), may receive treatment for hyperlipidemia as long as on a stable regimen for the previous one month\n* Presence of kidney disease, liver disease, hyperthyroidism, untreated or unstable hypothyroidism, certain cancers, gastrointestinal disease, pancreatic disease, other chronic metabolic diseases or malabsorption syndromes, HIV, or inflammatory conditions (such as arthritis, asthma, Crohn's disease, inflammatory bowel disease, gout, Lupus)\n* History of bariatric or certain other surgeries related to weight control\n* Any medication used to lower blood glucose\u002Fantidiabetic medications \\[including, but not limited to metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues, sodium-glucose cotransporter-2 (SGL2) inhibitors, thiazolidinediones, dipeptidyl peptidase (DPP)-IV inhibitors\\] as well as medications affecting weight, appetite\u002Fhunger or gut motility.\n* Smoking or use of other tobacco products (during 6 months prior to the start of the study)\n* Antibiotic use during the intervention or for 3 weeks prior to any treatment period\n* History of eating disorders or other significant food preferences that would interfere with the diet intervention (e.g., vegan lifestyle, very low-fat diets, high-protein diets)\n* Allergies or adverse reactions to study foods (e.g., gluten intolerance), or food aversions that would interfere with diet adherence\n* Body weight loss of \\>10% within the last 6 months prior to study start\n* Unable or unwilling to give informed consent or communicate with study staff\n* Self-report of alcohol or substance abuse within the past 12 months and\u002For current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)\n* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol\n* Undergoing hormonal therapy of any kind, with the exception of a stable regime for the prior 6 months to study start.",true,"21 Years",{"count":340,"type":21},30,[88],"The purpose of this study is to see how adding avocado to a breakfast meal affects blood sugar control and signals of hunger and fullness after eating.\n\nThe investigators will test the effects of 3 breakfast meals on blood sugar control and signals of hunger and fullness after eating:\n\n1. Whole-wheat bread and strawberry jam\n2. Whole-wheat bread, strawberry jam, and avocado\n3. Whole-wheat bread and strawberry jam (meal enriched with fat and fiber to mimic that of an avocado)\n\nParticipants will undergo 3 test periods, each separated by a week. Each test period consists of one day with set meals that the investigators will provide (breakfast, lunch, and dinner), and then the next morning, participants will eat a breakfast meal and have blood drawn several times over 4 hours.",[344,345,346,347,348,349,350,351],"Healthy","Healthy Volunteer","Healthy Volunteers","Healthy Adult","Healthy Male and Female Subjects","Healthy Subjects","Healthy Volunteers Only","Healthy Non-smokers",[353,354,355,356,357,358,359,360,361,362,363,364,365,366,367,368,369,370],"Persea Americana","blood glucose","blood insulin","adiponectin","leptin","GLP-1","appetite","satiety","glucose tolerance","GIP","ghrelin","Peptide YY (PYY)","glucose metabolism","dietary fats","meal challenge","meal tolerance test","dietary fiber","glycemia","2025-03-24",{"date":373,"type":40},"2025-03-28",{"date":375,"type":21},"2025-03",{"date":377,"type":21},"2026-06",{"name":46,"class":47},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":392,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":48},"100495992","remote-smoking-cessation-in-hospitalized-cardiac-patients-100495992","NCT05738408","Remote Smoking Cessation in Hospitalized Cardiac Patients","Remote Smoking Cessation in Hospitalized Cardiac Patients: Bridging the Post-discharge","Inclusion Criteria:\n\nPatients will be recruited if they:\n\n1. Hospitalization for an acute coronary event which includes myocardial infarction or coronary revascularization (percutaneous intervention or coronary artery bypass)\n2. live within 30 miles of UVMMC and are \\>18 years of age\n3. Current cigarette smoker (defined as reporting any use of cigarettes in the week before admission and \\>5 cigarette\u002Fday on average over the past 3 months)\n\nExclusion Criteria:\n\nPatients will be excluded if they have:\n\n1. severe dementia\u002FAlzheimer's disease\n2. an active malignancy, excluding non-melanoma skin cancer or low-grade prostate cancer under active surveillance\n3. exercise limiting vascular or neuromuscular disease\n4. Non-English Speaking\n5. No reliable smart-phone\n6. Current, regular use of smokeless tobacco or other form of non-combusted tobacco",{"count":387,"type":21},50,[88],"The investigators are proposing to examine new strategies for helping patients hospitalized for an acute coronary event adhere to recommendations to quit smoking. The investigators are interested to see whether offering financial incentives for smoking cessation, combined with medications to ameliorate withdrawal, can significantly reduce smoking in a population for which continued smoking has disproportionately negative health effects. The proposed trial can provide significant knowledge for promoting adherence to smoking cessation guidelines in patients with cardiac disease",[391],"Smoking Cessation",[393,394],"smoking cessation","secondary prevention","2025-01-16",{"date":397,"type":40},"2025-01-20",{"date":399,"type":40},"2022-08-12",{"date":401,"type":21},"2025-12",{"name":46,"class":47},{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":4,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":22,"phases":411,"briefSummary":412,"conditions":413,"keywords":417,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":4},"100574428","phase-2-phase-ii-clinical-trial-of-de-intensified-therapy-in-human-papilloma-virus-hpv-associated-oropharyngeal-squamous-cell-carcinoma-100574428","NCT06759155","Phase II Clinical Trial of De-Intensified Therapy in Human Papilloma Virus (HPV) Associated Oropharyngeal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Histologically confirmed or suspected HPV associated squamous cell carcinoma of the oropharynx.\n* p16 immunohistochemistry is the surrogate marker for HPV positivity and will be scored as positive if there is strong and diffuse nuclear and cytoplasmic staining present in greater than 70% of the tumor specimen. (A negative result excludes the patient from the trial)\n* In the case of equivocal p16, High Risk HPV (HR HPV), In-Situ Hybridization (ISH) \u002F Polymerase Chain Reaction (PCR) may be performed to determine HPV positivity\n* AJCC TNM 7th edition stage T1-T3, N0-N2b (or AJCC TNM 8th edition stage T1-T3 N0-N1) disease.\n* Staging will be based on cross sectional imaging investigations and clinical exam.\n* Patients who initially have an unknown primary but subsequently have a primary site identified on pathology after surgical resection may be included in the study.\n* Multidisciplinary team decision to treat with primary transoral resection and neck dissection.\n* Patients considered fit for surgery and adjuvant therapy.\n* Aged 18 or over.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* HPV negative squamous cell carcinomas of the head and neck\n* T4 and\u002For T1-T3 tumors where transoral surgery is considered not feasible or there is a high likelihood of positive margins.\n* AJCC TNM 7th edition N2c-N3 nodal disease (or AJCC TNM 8th edition N2-N3 nodal disease) or high likelihood of gross extranodal extension.\n* Patients for whom transoral surgery and neck dissection is not considered the primary treatment modality.\n* Distant metastatic disease as determined by routine pre-operative staging radiological investigations e.g. CT thorax and upper abdomen or PET CT.\n* Women who are pregnant or breastfeeding\n* Prior history of radiation to head and neck",{"count":410,"type":21},20,[24],"HPV-associated Oropharyngeal Squamous Cell Carcinoma (OPSCC) is a type of cancer that affects parts of the throat, like the tonsils and the base of the tongue. The treatments for OPSCC, which may include surgery, radiation, and chemotherapy, often cause serious side effects, such as loss of taste, dry mouth, and long-term problems with swallowing. These side effects can lower patients' quality of life and make it difficult for them to eat and speak normally.\n\nThis study aims to explore whether using lower doses of radiation after surgery can help improve long-term swallowing function in patients with HPV-positive OPSCC. By doing this, the study team hopes to reduce treatment-related side effects while maintaining good cancer control.",[414,415,416],"OPSCC","Oropharyngeal Squamous Cell Carcinoma (SCC)","HPV Associated Cancers",[418,419],"radiation","de-intensify","2024-12-27",{"date":422,"type":40},"2025-01-06",{"date":424,"type":21},"2025-01",{"date":426,"type":21},"2030-01",{"name":46,"class":47},""]