[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Vermont\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":507},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,46,66,85,108,131,160,182,210,233,259,283,305,328,347,377,403,430,461,484],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100602929","contingency-management-to-improve-medication-for-opioid-use-disorder-continuation-after-the-emergency-department-100602929",false,"NCT07129902","Contingency Management to Improve Medication for Opioid Use Disorder Continuation After the Emergency Department","Contingency Management to Improve Medication for Opioid Use Disorder Continuation After Discharge From the Emergency Department","CM+ED+MOUD","Major inclusion criteria include\n\n* STAR referral to outpatient clinic (Addiction Treatment Center and Chittenden Clinic) with prescription for buprenorphine or methadone.\n* Age ≥18 years.\n* Provide informed consent.\n\nExclusion Criteria\n\n* Pending incarceration in the next 30 days.\n* Plan to leave the area (Burlington\u002FChittenden County) in the next 30 days.\n* Physical, health, or structural challenge that prevents attendance at outpatient clinic.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","Project Summary The goal of this pilot clinical trial is to assess contingency management (CM) for increasing attendance at outpatient clinics after Medication for Opioid Use Disorder (MOUD) prescription and clinic referral occurred in the hospital Emergency Department (ED).\n\n* The researchers will compare usual care (UC)+CM to UC alone to see if 1) CM works to promote MOUD clinic attendance after discharge from the ED and 2) demonstrate feasibility of providing CM in the ED and outpatient MOUD clinic settings.\n* Researchers will randomize 30 adults who started MOUD in the ED into two conditions. These conditions consist of (A) UC alone: A referral to an outpatient buprenorphine or methadone provider with reminders from STAR program staff or (B) UC+CM: UC plus financial incentives dependent on MOUD clinic attendance to receive an MOUD prescription.\n\nThe primary outcome of interest is the number of participants who receive their first MOUD prescription from the outpatient clinic after discharge from the ED in UC+CM compared to the UC-only condition. A secondary outcome will be the proportion of participants who kept attending outpatient MOUD treatment by the end of the 30-day study period between UC+CM and UC conditions. An exploratory outcome will be biochemically-verified illicit opioid abstinence measured at day 30.",[27],"Opioid Use Disorder",[29,30,31,32],"contingency management","medication for opioid use disorder (MOUD)","emergency departments","opioid use disorder","RECRUITING","2026-05-27",{"date":36,"type":37},"2026-05-29","ACTUAL",{"date":39,"type":37},"2025-09-02",{"date":41,"type":21},"2027-05",{"name":43,"class":44},"University of Vermont","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":45},"100538275","novel-telemedicine-delivered-prolonged-exposure-therapy-for-treating-ptsd-in-individuals-with-oud-100538275","NCT06288711","Novel Telemedicine-Delivered Prolonged Exposure Therapy for Treating PTSD in Individuals With OUD","Inclusion Criteria:\n\n* \\>18 years old\n* Maintained on a stable methadone or buprenorphine dose for \\>1 month prior to the study\n* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5\n* Participants receiving psychotropic medications must be maintained on a stable dose for \\>1 month prior to enrollment.\n\nExclusion Criteria:\n\n* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview\n* Cognitive impairment as evidenced by scores \\\u003C22 on the Videoconference-based Mini Mental Status Examination (MMSE; Folstein, et al., 1975)\n* Enrolled in another ongoing evidence-based treatment for PTSD.\n* Pregnancy as verified by pregnancy test\n* No access to cellular service",{"count":53,"type":21},135,[24],"Among individuals with opioid use disorder (OUD), posttraumatic stress disorder (PTSD) presents a significant clinical challenge. The prevalence of PTSD is substantially higher in individuals with OUD than in the general population, with nearly 90% reporting lifetime trauma exposure and 33% meeting diagnostic criteria for PTSD. The primary objective of this study is to evaluate the efficacy of a novel telemedicine-delivered prolonged exposure therapy protocol for improving PE attendance and reducing PTSD symptom severity in individuals with concurrent PTSD and OUD.",[27,57],"Posttraumatic Stress Disorder","2026-05-13",{"date":60,"type":37},"2026-05-18",{"date":62,"type":37},"2024-06-03",{"date":64,"type":21},"2027-11-30",{"name":43,"class":44},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":72,"minAge":18,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":45},"100567583","prolonged-exposure-therapy-to-treat-posttraumatic-stress-disorder-in-pregnant-patients-100567583","NCT06670079","Prolonged Exposure Therapy to Treat Posttraumatic Stress Disorder in Pregnant Patients","Inclusion Criteria:\n\n* Female\n* \\>18 years old\n* Gestational age ≤ 25 weeks\n* Meet current DSM-5 posttraumatic stress disorder criteria based on the Clinician Administered PTSD Scale for DSM-5\n* Participants receiving psychotropic medications must be maintained on a stable dose for \\>14 days prior to enrollment.\n\nExclusion Criteria:\n\n* Male\n* Under 18 years old\n* Gestational age \\> 25 weeks\n* No current diagnosis of PTSD\n* Current delusions or hallucinations, unstable bipolar disorder, imminent risk for suicide as assessed by the Mini International Neuropsychiatric Interview\n* Enrolled in another ongoing evidence-based treatment for PTSD.","FEMALE",{"count":20,"type":21},[24],"The goal of this clinical trial is to learn if a treatment for adults with PTSD called prolonged exposure + incentives (PE+) works to treat pregnant patients. The main question it aims to answer is:\n\nDoes PE+ decrease PTSD symptoms?\n\nAll participants will receive PE+ to see if their PTSD symptoms at the end of the trial are less than at the beginning.\n\nParticipants will:\n\n* Receive individual PE+ therapy for 1 hour weekly for 12 weeks.\n* Receive financial incentives for attending each PE+ session.\n* Attend assessment visits every 4 weeks for the 12 weeks of the trial.\n* Allow research staff to collect some information about their labor and delivery from their medical records after their babies are born.",[57,77],"Pregnancy","2026-05-08",{"date":58,"type":37},{"date":81,"type":37},"2026-02-05",{"date":83,"type":21},"2027-07-22",{"name":43,"class":44},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100631009","phase-1-phase-1b-trial-of-intratumoral-cisplatin-for-stage-iv-lung-cancer-100631009","NCT07495098","Phase 1B Trial of Intratumoral Cisplatin for Stage IV Lung Cancer","2.5.1 Inclusion criteria\n\n* Age 18 years or above\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n* Have known or suspected metastatic NSCLC at time of enrollment (including patients who progress on initial therapy or are found to have metastatic disease during therapy and are not excluded\n* Patient is able and willing to provide informed consent.\n* Rapid on-site cytopathologic examination (ROSE) performed during the procedure (if not previously diagnosed) and returns likely NSCLC. No injection will be performed if ROSE is non-diagnostic.\n* A CT scan of the chest (with or without contrast) within the prior 3 months.\n* The presence of an EBUS accessible target site determined by a treating investigator. These may be primary lung cancers or metastatic sites (including when a lymph node station has been replaced by metastatic tumor), that are accessible by EBUS.\n* MDC agreement of likely Stage IV NSCLC (confirmation from at minimum a Medical Oncologist and Radiation Oncologist on clinical stage).\n* Patients must have adequate organ and marrow function as defined below:\n\n  * Leukocytes ≥3,000\u002FmcL\n  * Platelets ≥100,000\u002FmcL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN)\n  * AST(SGOT)\u002FALT(SGPT) ≤ institutional ULN\n  * Creatinine ≤ institutional ULN\n\n2.5.2 Exclusion criteria\n\n* Use of an investigational agent in prior 30 days\n* Pregnancy\u002Flactation (pregnancy test to be performed by pre-op as part of standard of care for women of child-bearing age as defined by UVMMC Policy NPREP16)\n* Treatment with intravenous cytotoxic chemotherapy within the past 14 days\n* Allergy to cisplatin or its derivatives\n* Allergy to iodinated contrast\n* Patient not appropriate for the research study based on physician discretion",{"count":92,"type":21},12,[94],"PHASE1","The addition of intravenous (given through a vein) cisplatin to immunotherapy improves treatment outcomes for lung cancer, but unfortunately results in significantly more side effects since the rest of the body is exposed to significant amounts of the drug. Our clinical trial data indicate that injecting cisplatin directly into the tumor using a bronchoscope (a small flexible tube with a camera in it) has very few side effects, and results in significant cell death and potentially improvement in the immune response. The goal of this proposal is to evaluate a computational approach, that incorporates data from a CT scan, to determine the optimal dose and delivery location within a tumor to maximize tumor cell killing and the immune response.",[97,98],"Lung Cancer Metastatic","Lung Cancer (NSCLC)","NOT_YET_RECRUITING","2026-03-20",{"date":102,"type":37},"2026-03-27",{"date":104,"type":21},"2026-07-01",{"date":106,"type":21},"2031-06-30",{"name":43,"class":44},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":45},"100549358","accelerated-pulmonary-rehabilitation-in-the-preoperative-period-100549358","NCT06432972","Accelerated Pulmonary Rehabilitation in the Preoperative Period","PREHAB","Inclusion Criteria:\n\n* Age 18 years or older\n* Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by physicians specializing in lung cancers\n* Eligible for treatment\n* Current cigarette smoking ≥5 cigarettes per day\n* Willing to attempt smoking cessation during prehab period\n* Willing to take nicotine replacement therapy (NRT) and varenicline\n* Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days during treatment\n* Willing and able to provide informed consent; ability determined by study physician and\u002For LMDC treatment physicians\n\nExclusion Criteria:\n\n* Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and\u002For treatment physicians\n* Inability to consistently attend PR during treatment\n* Pregnancy, per patient self-report\n* Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study\n* Any other condition in the opinion of the investigator\u002Fstudy physician and or treatment physicians that would jeopardize patient safety or integrity of research results",{"count":5,"type":21},[24],"This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of a new lung nodule, either confirmed or suspicious for lung cancer, with a plan for lung cancer treatment with or without surgical resection will be recruited from the University of Vermont Medical Center (UVMMC)pulmonary, cardiothoracic surgery, and Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications.\n\nInvestigators estimate that 20 participants over a two-year period will be sufficient to measure the safety and feasibility of this study. Investigators aim to enroll, on average, 2 participants per month in order to complete this study in a timely fashion. Participants will be enrolled in prehab on a rolling basis, as to not delay surgical timeline.",[119,120],"Chronic Obstructive Pulmonary Disease","Lung Cancer",[122],"Pulmonary Rehab","2026-03-18",{"date":125,"type":37},"2026-03-23",{"date":127,"type":37},"2024-01-02",{"date":129,"type":21},"2026-06-30",{"name":43,"class":44},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":143,"conditions":144,"keywords":148,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":45},"100629649","phase-1-pdac-regression-and-intraoperative-surgical-margin-with-neoadjuvant-tamp-prism-tamp-100629649","NCT07477418","PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP)","PDAC Regression and Intraoperative Surgical Margin With Neoadjuvant TAMP (PRISM-TAMP): A Phase Ib\u002FII Open-Label Trial","PRISM-TAMP","Inclusion Criteria:\n\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC).\n* Borderline resectable disease as defined by the ABC classification criteria, incorporating one or more of the following:\n\n  * Anatomy (A): Vascular involvement consistent with borderline resectable or resectable locally advanced-PDAC (e.g., abutment of the superior mesenteric vein or artery, portal vein, or celiac axis) as determined by cross-sectional imaging\n  * Biology (B): Concern for extra-pancreatic metastasis or known N1 disease or suspicious but nonconfirmatory liver\u002Flung lesion(s). CA19-9\\>500 after normalized bilirubin\n  * Condition (C): Functional status and comorbidity profile adequate for curative-intent surgery, as assessed by the multidisciplinary team, specifically WHO PS \\>\u002F=1.\n* No prior treatment for PDAC (e.g., chemotherapy, radiation, or surgery).\n* Age ≥ 18 years.\n* ECOG performance status of 0 or 1.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Locally Advanced PDAC or metastatic PDAC\n* Histology other than adenocarcinoma\n* Non-accessible arterial anatomy\n* Gemcitabine hypersensitivity or contraindication to mFOLFIRINOX therapy based on provider assessment",{"count":140,"type":21},10,[94,142],"PHASE2","Pancreatic ductal adenocarcinoma (PDAC) is an aggressive cancer with poor survival outcomes, even when treated with modern chemotherapy and radiation. Patients with borderline resectable PDAC often receive neoadjuvant systemic therapy to improve the likelihood of successful surgical removal of the tumor, but rates of incomplete tumor regression and positive surgical margins remain high.\n\nThis Phase Ib\u002FII, single-arm study evaluates the safety and feasibility of adding trans-arterial microperfusion (TAMP) delivery of gemcitabine to standard neoadjuvant therapy for patients with borderline resectable PDAC. In this study, patients receive standard systemic chemotherapy with modified FOLFIRINOX followed by stereotactic body radiation therapy (SBRT). After completion of chemoradiation, gemcitabine is delivered directly to the tumor through the arterial blood supply using the RenovoCath® catheter system. Gemcitabine is an FDA-approved chemotherapy drug for pancreatic cancer, and the study is evaluating a novel method of delivering the drug rather than a new medication.\n\nThe primary objective of the study is to assess the safety and tolerability of neoadjuvant TAMP-delivered gemcitabine in this treatment setting. Secondary objectives include evaluation of surgical margin status and pathologic tumor regression following surgical resection. Exploratory analyses will examine relapse-free survival. Results from this study will help determine whether this locoregional chemotherapy approach can be safely integrated into neoadjuvant treatment strategies for patients with borderline resectable PDAC.",[145,146,147],"Pancreatic Ductal Adenocarcinoma (PDAC)","Borderline Resectable Pancreatic Cancer","Pancreatic Neoplasms",[149,150,151],"Neoadjuvant Therapy","Gemcitabine","Intra-arterial Chemotherapy","2026-03-12",{"date":154,"type":37},"2026-03-17",{"date":156,"type":21},"2026-12",{"date":158,"type":21},"2031-12",{"name":43,"class":44},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100421098","remote-monitoring-and-management-of-chemotherapy-induced-peripheral-neuropathy-100421098","NCT04763356","Remote Monitoring and Management of Chemotherapy Induced Peripheral Neuropathy","REMOTE-CIPN","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Age ≥ 18.\n2. Completion of taxane, platinum, vinca alkaloid-based chemotherapy, bortezomib, thalidomide, lenalidomide, ixazomib, or brentuximab vedotin for cancer in the last 540 days, or ongoing maintenance therapy with bortezomib, thalidomide, lenalidomide or ixazomib for \\> 90 days or ongoing survival, palliative or equivalent therapy with any of the above listed drugs for \\>90 days.\n3. Development of CIPN during or within 3 months of the most recently completed chemotherapy or previous neurotoxic chemotherapy for the same malignancy. For patients on ongoing maintenance therapy: Development of CIPN during current neurotoxic chemotherapy with bortezomib, thalidomide, lenalidomide, ixazomib brentuximab vendotin or vincristine. CIPN diagnosis will be based on clinical diagnosis and the Toronto Criteria for Probable Distal Symmetric Polyneuropathy including the upper and lower extremities.\n\n   The Toronto Criteria for Probable Distal Symmetric Polyneuropathy is defined as a combination of symptoms and signs of neuropathy including:\n   1. At least 1 (one) of the following neuropathic symptoms: \"asleep numbness\", prickling or stabbing, burning or aching pain AND\n   2. At least 1 (one) of the following: decreased distal sensation, or unequivocally decreased or absent ankle reflexes. (59)\n\n   Clinical Diagnosis:\n\n   a. Confirmation of CIPN diagnosis by CIPN expert (investigator\u002Fco-infestigator based on chart review +\u002F- inperson\u002Fvirtual interview with examination).\n4. Presence of at least one positive neuropathic sensory symptom on the NTSS-6 ranked as moderate or severe on the day of screening or in the preceding week based on recall.\n5. The ability to speak\u002F read sufficient English to be able to communicate with study NP over the phone, utilize the App, website and phone tree (all of which are only available in English).\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Expected treatment with another neurotoxic chemotherapy within the 13 week overall study duration (For example, platinum, taxane, vinca alkaloid, thalidomide, brentuximab vedotin or related drug, or arsenic trioxide. This exclusion does not apply to continuation of treatment for patients on maintenance therapy as described in the inclusion criteria).\n2. Presence of a neurological problem that would confound CIPN assessment (lumbar or cervical radiculopathy, or pre-existing neuropathy from another cause such as diabetes).\n3. Currently receiving treatment at a pain clinic specifically for CIPN pain.\n4. Concurrent participation in a different CIPN or pain treatment trial.\n5. For women of childbearing potential: Current pregnancy\n6. For women of childbearing potential: Unwillingness to use and acceptable form of birth control for the duration of the study. Acceptable forms of birth control include long acting implantable contraception (ie IUDs, Nexplanon), Oral contraception pills, contraception injections, or strict abstinence if it is part of the subject's current lifestyle.",{"count":168,"type":21},422,[24],"This is a prospective randomized trial designed to investigate a new care model for patients who suffer from nerve damage from chemotherapy called chemotherapy induced peripheral neuropathy (CIPN). All participants in the study will report their CIPN symptoms daily using a website, app or phone for 12 weeks. In one group the data will be collected and participants will be encouraged to reach out to their treating doctors for uncontrolled symptoms. These participants' doctors can prescribe any treatment they feel is appropriate. In the second group, if the symptoms meet the criteria for eligibility they will receive a phone call from a nurse practitioner either the same day or next day, depending on the time symptoms were logged. That nurse practitioner will determine the correct CIPN treatment using an algorithm and prescribe it. The study will track the severity of symptoms over time as well as looking at the impact on treatments for CIPN (medications and referrals).",[172],"Chemotherapy-induced Peripheral Neuropathy","2026-03-06",{"date":175,"type":37},"2026-03-10",{"date":177,"type":37},"2023-01-10",{"date":179,"type":21},"2026-09-30",{"name":43,"class":44},3,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":190,"minAge":191,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":45},"100626823","re-fit-remote-exercise-for-physical-function-in-wtc-responders-with-prostate-cancer-100626823","NCT07440641","RE-FIT (Remote Exercise for Physical Function in WTC Responders With Prostate Cancer)","A Pilot Randomized Controlled Trial of Remote Exercise to Improve Physical Function in World Trade Center (WTC) Responders With Prostate Cancer","RE-FIT","Inclusion Criteria:\n\n* World Trade Center (WTC) Health Program-certified diagnosis of prostate cancer\n* Completed initial treatment for prostate cancer (for example, surgery or radiation); participants may be on active surveillance or receiving androgen deprivation therapy\n* Low levels of regular physical activity (less than 90 minutes per week of moderate-to-vigorous activity and\u002For less than two strength-training sessions per week)\n* Able to understand and provide written informed consent (electronically or by mail)\n* Willing and able to participate in remotely delivered exercise sessions using videoconferencing\n\nExclusion Criteria:\n\n* Metastatic cancer\n* Unable to ambulate independently, with or without an assistive device\n* Moderate or severe cognitive impairment\n* Unable to communicate in English\n* Unable or unwilling to attend scheduled exercise sessions (three times per week for 16 weeks)\n* Current participation in another structured exercise program or clinical trial that could confound study outcomes\n* Unstable or serious medical conditions that would pose a safety risk or limit compliance (for example, uncontrolled cardiovascular disease, severe psychiatric illness, or organ failure)\n\nImplanted cardioverter defibrillator (ICD) or recent lower extremity deep vein thrombosis\n\n\\-","MALE","55 Years",{"count":193,"type":21},40,[24],"People who responded to the World Trade Center (WTC) disaster on September 11, 2001 were exposed to toxic dust and smoke and have higher rates of certain health problems, including prostate cancer. Many WTC Responders with prostate cancer experience ongoing physical limitations, fatigue, and reduced quality of life, even after completing cancer treatment. Regular exercise can improve strength, balance, physical function, and well-being in people with cancer, but many men with prostate cancer do not meet recommended physical activity levels. Barriers such as travel, health concerns, and lack of access to tailored programs can make it difficult to participate in exercise programs.\n\nThis pilot study will test whether a remotely delivered, supervised group exercise program is feasible and acceptable for WTC Responders with prostate cancer. The exercise program is delivered live by videoconference and is based on an established, evidence-based program for older adults. It includes aerobic, strength, balance, and flexibility exercises and is designed to be safe, supportive, and accessible to people living in different locations.\n\nA total of 40 WTC Responders with a history of prostate cancer will take part in this study. Participants will be randomly assigned to either (1) a 16-week remote exercise program or (2) a waitlist control group that receives usual care during the study period and is offered the exercise program after completing all study assessments. Participants in the exercise group will attend three one-hour exercise sessions per week using videoconferencing.\n\nThe main goals of this study are to determine whether participants can be successfully recruited and retained, whether they attend and complete the exercise sessions, and whether they find the program acceptable and helpful. The study will also explore whether the exercise program improves physical function, physical activity, and quality of life. Physical function will be measured using simple movement tests performed remotely, and physical activity will be measured using a wearable activity monitor. Participants will also complete questionnaires about their health, physical functioning, and experiences with the program.\n\nIn addition, this study will evaluate whether it is feasible for participants to collect saliva samples at home and return them by mail for future research. A subset of participants will be invited to complete interviews to share their experiences and provide feedback on how the program could be improved.\n\nResults from this pilot study will help inform the design of a larger future trial aimed at improving physical function and quality of life for WTC Responders with prostate cancer through accessible, remotely delivered exercise programs.",[197],"Prostate Cancer",[199,200,201],"exercise","World Trade Center Responders","Cancer Survivorship","2026-02-25",{"date":204,"type":37},"2026-02-27",{"date":206,"type":21},"2026-06-01",{"date":208,"type":21},"2035-01-20",{"name":43,"class":44},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":45},"100622596","comparing-the-effectiveness-of-the-think-in-nerve-length-and-layers-tinll-approach-to-traditional-treatment-for-patients-with-lateral-elbow-pain-100622596","NCT07385677","Comparing the Effectiveness of the 'Think in Nerve Length and Layers' (TINLL) Approach to Traditional Treatment for Patients With Lateral Elbow Pain.","Inclusion Criteria:\n\n* understanding of English language; adults 18 years of age or older\n* referral for lateral sided elbow pain or lateral epicondylitis\n* subjects positive on one of the following (tenderness over lateral epicondyle with palpation\n* pain with stretch of long wrist extensors\n* pain with resisted wrist or middle finger extension)\n\nExclusion Criteria:\n\n* subjects unable to cognitively follow directions\n* have a legally-mandated reporter\n* subjects scheduled for surgery, or post-up surgical patients\n* subjects with carpal tunnel syndrome, cubital tunnel syndrome\u002Fmedial elbow pain,\n* subjects who received Platelet-Rich Plasma (PRP) or percutaneous needle tenotomy (PNT)",{"count":217,"type":21},68,[24],"Lateral elbow pain can significantly limit people's ability to do the activities they want or need to do. We want to explore if one treatment technique is better than another for people with lateral elbow pain.\n\nYou will be placed in a traditional treatment group or in a non-traditional treatment group. Your placement in the group will depend on past treatments you have had for this pain.\n\nBefore you start treatment, you will be given four tests: 1) a grip strength test, 2) a pinch test, 3) a pain level survey, and 4) a functional survey. These four tests will take no longer than 15 minutes to complete. These four tests are common tests given to people with elbow pain. You will be given these four tests:\n\n* At the beginning, before you start treatment\n* At 2-weeks\n* At 4-weeks\n* At the end of your treatment\n\nTraditional treatment group: You will receive treatment 1x\u002Fweek for 4-6 weeks. The traditional treatment group will consist of the following treatments:\n\n* stretching and strengthening of the wrist extensors\n* soft tissue work to the forearm muscles\n* joint mobilization at the elbow\n* rigid and elastic taping with focus on the wrist extensor muscles\n* ergonomic strategies\n* transcutaneous electrical nerve stimulation (TENS)\n* wrist splinting\n\nNon-traditional (TINLL) treatment group: You will receive treatment 1x\u002Fevery 1-2-weeks for 4-6 weeks. The non-traditional (TINLL) treatment group will consist of the following treatments:\n\n* joint and tendon mobilization at the elbow\n* elastic tape for muscles and nerves\n* stretching\u002Fstrengthening of the muscles at the elbow and upper arm\n* ergonomic strategies",[221],"Lateral Elbow Tendinopathy (Tennis Elbow)",[223,224],"lateral elbow pain","radial nerve","2026-02-02",{"date":227,"type":37},"2026-02-04",{"date":229,"type":37},"2024-11-26",{"date":231,"type":21},"2026-11-26",{"name":43,"class":44},{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":190,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":22,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":45},"100590857","phase-2-fezolinetant-for-treating-hot-flashes-in-men-with-prostate-cancer-100590857","NCT06972875","Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer","Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms Associated With Androgen-Deprivation Therapy in Men With Prostate Cancer (FLASH): A Phase 2 Study","FLASH","Inclusion Criteria:\n\nAge ≥ 18 years Men who are currently receiving Androgen Deprivation Therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists (e.g. leuprolide, degarelix, relugolix). Men receiving Androgen Receptor Pathway Inhibitors (ARPI) such as abiraterone, enzalutamide, apalutamide, and darolutamide are eligible.\n\nPatients must be on a stable dose of all hormonal therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Additional ARPI agents (e.g. abiraterone or enzalutamide) are allowed to be added during the Extension Phase of the trial, but not during the Treatment Phase.\n\nPatients receiving radiation therapy during the study period are eligible. An eligible patient must have bothersome hot flashes for ≥ 7 days prior to consent, resulting in an average of four or more hot flashes per day of sufficient severity to cause the patient to seek therapeutic intervention.\n\nLife Expectancy of 6 months or greater. Language: In order to complete the mandatory participant-completed measures, participants must be able to speak and read English.\n\nExclusion Criteria:\n\nCurrent or future planned use of any of the following agents during the study period: drugs that are not FDA approved for use in humans, any drug with category X interactions with fezolinetant; androgens, estrogens, progesterone analogs, or complementary\u002Falternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration. Stable dosing (≥ 1 month) of gabapentin, cholinergic agonists, cholinesterase inhibitors for other indications is permitted.\n\nHistory of cirrhosis Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 X ULN or total bilirubin \\> ULN eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 based on reported MDRD estimate. Current use of CYP1A2 inhibitors (fezolinetant is a substrate of CYP1A2).",{"count":242,"type":21},32,[142],"This study is for men with prostate cancer who are experiencing hot flashes due to treatments that lower testosterone. Hot flashes can affect your quality of life and make it harder for patients to continue their treatment, so researchers want to find a better way to manage them. The study is testing a drug called fezolinetant, which might help reduce hot flashes without using hormones. Fezolinetant is a drug that is currently approved for the treatment of hot flashes in menopausal women.",[246,247],"Prostate CA","Androgen Deprivation Therapy",[249,250,251,252],"prostate cancer","androgen deprivation therapy","hot flash","fezolinetant",{"date":81,"type":37},{"date":255,"type":37},"2025-12-18",{"date":257,"type":21},"2027-02",{"name":43,"class":44},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":275,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":277,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":45},"100593329","phase-3-doac---dosing-options-in-anticoagulation-prophylaxis-100593329","NCT07005024","DOAC - Dosing Options in AntiCoagulation Prophylaxis","A Comparison of Anticoagulant Dosing Strategies to Reduce VTE and Mortality in Cancer Outpatients: A Randomized, Pragmatic Trial","DOAC","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with an active solid tumor or lymphoma\n* Starting a new systemic cancer treatment or changing cancer treatment\n* Khorana Risk Score of 2 (calculated based on lab and clinical data at treatment initiation)\n* Not currently receiving therapeutic anticoagulation\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Active bleeding or high risk of bleeding (e.g., recent major surgery, CNS tumors with hemorrhagic risk)\n* Known contraindication to apixaban (e.g., allergy, severe liver disease, dual strong CYP3A4 and P-gp inhibitors)\n* Current therapeutic-dose anticoagulation for VTE or atrial fibrillation\n* Platelet count \\\u003C 50,000\u002FµL\n* Creatinine clearance \\\u003C 25 mL\u002Fmin\n* Life expectancy \\\u003C 3 months\n* Pregnant or breastfeeding\n* Inability to comply with study procedures",{"count":268,"type":21},996,[270],"PHASE3","Blood clots, also known as venous thromboembolism (VTE), are a common and serious complication for people with cancer. They can lead to pain, hospitalizations, delayed cancer treatment, and even death. Although national guidelines recommend using blood thinners (anticoagulants) to prevent clots in cancer patients who are at higher risk, these medications are not commonly prescribed due to concerns about bleeding and inconvenience.\n\nThis study will test different ways of using a commonly prescribed blood thinner called apixaban (brand name Eliquis) to see if it can safely and effectively reduce the risk of blood clots and death in cancer patients who are at moderate risk for VTE. The study focuses on people who have a \"Khorana score\" of 2, which puts them at intermediate risk for developing blood clots.\n\nThe study will include approximately 996 participants with solid tumors or lymphoma who are starting or recently started cancer-directed therapy. Participants will be randomly assigned to one of three groups:\n\nGroup 1: Apixaban 2.5 mg twice a day (standard prophylactic dose)\n\nGroup 2: Apixaban 5 mg once a day (an alternative, more convenient dose)\n\nGroup 3: No anticoagulant (standard care)\n\nParticipants will take the assigned treatment (if applicable) for 6 months. Researchers will monitor whether participants develop blood clots, experience serious bleeding events, or die from any cause during the study period.\n\nBy comparing these three groups, the researchers hope to learn whether a once-daily dose of apixaban can work as well as the standard twice-daily dose, and whether either dosing strategy is better than no anticoagulation at all. If successful, the study may help increase the safe use of VTE prevention in cancer patients and improve overall outcomes, especially in patients at intermediate risk.\n\nThis is a pragmatic trial, meaning it is designed to fit into real-world clinical practice with minimal extra procedures. The study drug is not provided by the sponsor and will be prescribed and filled through usual care channels. Participants and their doctors will decide whether to continue the medication after the study ends.",[273,274],"Cancer","VTE (Venous Thromboembolism)",[276],"Apixaban",{"date":81,"type":37},{"date":279,"type":37},"2025-10-17",{"date":281,"type":21},"2035-08",{"name":43,"class":44},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":291,"phases":4,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":45},"100569334","defining-inflammatory-markers-of-cardiovascular-disease-in-patients-with-myelodysplastic-syndromes-100569334","NCT06692894","Defining Inflammatory Markers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes","Defining Inflammatory Biomarkers of Cardiovascular Disease in Patients With Myelodysplastic Syndromes","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed diagnosis of MDS by bone marrow biopsy morphology, using the 2022 World Health Organization (WHO) classification for myeloid neoplasms\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤3\n* Expected survival of at least 6 months\n* Ability to provide consent\n\nExclusion Criteria:\n\n* Cases meeting 2022 WHO criteria of MDS with excess blasts 2 as initial diagnosis\n* Hematopoietic stem cell transplantation expected within 6 months",{"count":20,"type":21},"OBSERVATIONAL","Why Is This Research Study Being Conducted?\n\n* The study wants to find out why people with a type of blood cancer called myelodysplastic syndromes (MDS) are more likely to have heart problems like heart disease and stroke.\n* Researchers also want to see if certain proteins related to inflammation in the body can help predict these heart issues in MDS patients.\n* By understanding this better, researchers hope to find new ways to detect and manage heart disease risks in people with MDS",[294],"Myelodysplastic Syndromes, Adult",[296,297],"Myelodysplastic Syndromes","Hematology",{"date":299,"type":37},"2026-02-03",{"date":301,"type":37},"2024-11-05",{"date":303,"type":21},"2027-11",{"name":43,"class":44},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":17,"minAge":311,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":313,"briefSummary":314,"conditions":315,"keywords":317,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":327,"locationsCount":4},"100622446","readiness-to-change-and-the-implementation-of-home-modifications-for-adults-over-60-100622446","NCT07383727","Readiness to Change and the Implementation of Home Modifications for Adults Over 60","Inclusion Criteria:\n\n* Adults over 60\n* Living independently\n* Able to read, speak, understand English\n\nExclusion Criteria:\n\n* Individuals unable to legal represent themselves","60 Years",{"count":193,"type":21},[24],"This study is focused on home modifications and the changes that older adults may experience while aging. We are conducting this study to better understand how people feel about making changes to their homes or utilizing equipment to assist with home tasks.",[316],"Older Adults (60 - 85 Years Old)",[318,319,320,321],"readiness to change","home modifications","older adults","aging-in-place","2026-01-26",{"date":299,"type":37},{"date":325,"type":21},"2026-01-28",{"date":129,"type":21},{"name":43,"class":44},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":45},"100612261","food-insecurity-and-eating-behavior-among-adults-receiving-buprenorphine-or-methadone-maintenance-treatment-pilot-study-2-100612261","NCT07251283","Food Insecurity and Eating Behavior Among Adults Receiving Buprenorphine or Methadone Maintenance Treatment: Pilot Study 2","Inclusion Criteria:\n\n* \\>18 years old\n* receiving methadone or buprenorphine treatment for OUD\n* meet criteria for current FI as measured by the 18-item US Household Food Security Survey (FSS; Economic Research Service, USDA, 2012)\n\nExclusion Criteria:\n\n* Significant psychiatric or medical illness\n* Pregnant or nursing",{"count":193,"type":21},[24],"The goal of this study is to evaluate the effects of a novel, mail-based meal delivery intervention among individuals receiving MOUD on household food security status. The main question it aims to answer is:\n\n* Will participants randomized to the NE+MD intervention will demonstrate greater reductions in USDA FSS scores from intake to Study Week 24 than NE participants?\n\nParticipants with OUD and FI will be randomly assigned to one of two 24-week experimental conditions: Nutritional Education alone (NE) or NE + Meal Delivery (NE+MD).\n\nNE control participants will receive brief NE, a list of FI-related resources in their community, and assistance with contacting any resources of interest.\n\nNE+MD participants will receive the same educational platform plus commercial weekly meal deliveries directly to the participant's home (6 meals per week per household member).\n\nAll participants will complete monthly follow-up assessments throughout the 24-week study measuring food security status, psychosocial functioning, and biometric measures of health. All participants will also complete monthly follow-up assessments for 6 months post-intervention.",[338],"Food Security","2025-11-18",{"date":341,"type":37},"2025-11-26",{"date":343,"type":37},"2025-11-07",{"date":345,"type":21},"2027-07",{"name":43,"class":44},{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":353,"sex":17,"minAge":354,"maxAge":355,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":362,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":369,"lastUpdatePostDateStruct":370,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":45},"100530870","fatty-acid-modulation-of-brain-function-in-older-adults-100530870","NCT06192407","Fatty Acid Modulation of Brain Function in Older Adults","Inclusion Criteria:\n\n* Men and women age range 65-75 years\n* Normal cognition (see Research Strategy for details on cognitive assessments)\n* \"Healthy\" (body mass index (BMI) of 20-40 kg\u002Fm2)\n\nExclusion Criteria:\n\n* Significant cognitive or behavioral impairment (see Research Strategy for testing and exclusions) or pharmacological treatment for this (e.g. antipsychotics, anxiolytics, and sedative medications).\n* Hormone replacement therapy, past 3 months.\n* Hyper-androgenic condition.\n* HbA1C≥7.5% and or Fasting plasma glucose concentration ≥130 mg\u002FdL.\n* Type 2 Diabetes if receiving any other therapy than metformin.\n* Use of nicotine or ingestion of caffeine or alcohol during the study.\n* Habitual fat intake \\\u003C 25% of kcal or strict vegetarian diet.\n* Sleep apnea requiring continuous positive airway pressure at night.\n* Lung, cardiac (heart failure or its treatment), liver disease, renal disease, cancer, and any other medical disorder known or thought to cause inflammation or abnormalities of cognition\n* Actively training for an athletic event or participating in competitive sports (such as league play or tournaments)\n* Intolerance or allergy to any of the food provided in the study.",true,"65 Years","75 Years",{"count":357,"type":21},60,[24],"In this crossover study, the investigtors will administer two experimental diets in a random order for one week, and each experimental diet will be preceded by a one-week, low fat control diet for a total four-week study period. The goal is to study how the fatty acid content of the diet affects brain functioning in healthy adults aged 65-75 years. One experimental diet will have a high palmitic acid (PA)\u002Foleic acid (OA) ratio (HPA), typical of the North American diet. The other experimental diet will have a low PA\u002FOA ratio (HOA), typical of the Mediterranean Diet. All allowed food and drink (except water) will be provided by the investigative team, and compliance will be enhanced by constant, intense dietary surveillance by a registered dietitian.",[361],"Aging",[363,364,365,366,367,368],"fatty acids","diet","aging","MRI","palmitic acid","oleic acid","2025-09-10",{"date":371,"type":37},"2025-09-17",{"date":373,"type":37},"2024-04-15",{"date":375,"type":21},"2028-10-31",{"name":43,"class":44},{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":17,"minAge":383,"maxAge":384,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":391,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":395,"lastUpdatePostDateStruct":396,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":4},"100598697","clinical-screening-and-peer-interventions-to-prevent-substance-use-in-at-risk-adolescents-100598697","NCT07074860","Clinical Screening and Peer Interventions to Prevent Substance Use in At-Risk Adolescents","Inclusion Criteria:\n\n* Diagnosis of depression, anxiety, or ADHD\n\nExclusion Criteria:\n\n* Has not initiated substance use","11 Years","14 Years",{"count":386,"type":21},50,[24],"The goal of this clinical trial is to test a method of preventing substance use among adolescents. Young people aged 11-14 who have depression, anxiety, or attention deficit hyperactivity disorder (ADHD) are at higher than usual risk for starting substances such as alcohol, tobacco products, or drugs. The main question the investigators aim to answer is:\n\n\"Will watching short videos in their doctor's office every three months that were made by other adolescents in their community about not using drugs and other substances prevent at risk adolescents from starting to use those substances?\"\n\nThe investigators will measure the outcome by asking participants to complete a survey every three months. The survey is a standard set of questions about behavior, including substance use. If they have started to use substances, they will get treatment for substance use. If they have not, they will watch another video and come back three months later to repeat the survey.",[390],"Initation of Substance Use Disorder",[392,393,394],"Substance use prevention","Peer to peer support for adolescents","Video-based awareness raising","2025-07-10",{"date":397,"type":37},"2025-07-20",{"date":399,"type":21},"2025-09",{"date":401,"type":21},"2027-06",{"name":43,"class":44},{"id":404,"slug":405,"hasResults":11,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":353,"sex":17,"minAge":411,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":22,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":429},"100563310","phase-2-nicotine-regulation-for-dual-users-of-e-cigarettes-and-cigarettes-100563310","NCT06614504","Nicotine Regulation for Dual Users of E-cigarettes and Cigarettes","A Randomized Controlled Trial of Reduced Nicotine Cigarettes and E-cigarettes Among Dual Users","RDEC","Inclusion Criteria:\n\n* Regular use of tobacco\n* 21 year of age or older\n* Speak, comprehend and read English well enough to complete study procedures\n\nExclusion Criteria:\n\n* Pregnant, trying to become pregnant, or nursing\n* Under the age of 21\n* Health conditions that could undermine ability to complete the study","21 Years",{"count":413,"type":21},308,[142],"Cigarette smoking remains the leading cause of preventable morbidity and mortality in the US. Use of multiple tobacco products is becoming increasingly prevalent, with dual use of e-cigarettes and cigarettes representing the most common combination. Though e-cigarettes are not without risk, completely switching from cigarettes to e-cigarettes likely reduces risk for tobacco-related harm. However, many established dual users maintain long-term smoking and the majority who use e-cigarettes non-daily are at an even greater risk for prolonged smoking than exclusive cigarette smokers. The Food and Drug Administration Center for Tobacco Products (FDA CTP) has announced plans to implement a nicotine-limiting product standard, capping the nicotine in cigarettes at a minimally or non-addictive level. Randomized controlled trials (RCTs) demonstrate that adults who exclusively smoke cigarettes respond to very low nicotine content (VLNC) cigarettes with reductions in smoking, demand, and dependence. However, nicotine reduction RCTs to date have excluded people who regularly use e-cigarettes and therefore it remains unclear how a nicotine-limiting standard for cigarettes would affect smoking among dual users. Given the potential substitutability of e-cigarettes for cigarettes, reducing the nicotine in cigarettes could promote a transition to exclusive e-cigarette use among dual users unable to completely quit nicotine, but only if sufficiently appealing e-cigarettes remain available. E-cigarettes containing 5% nicotine-salt solution are currently most popular in the US, but policy makers have proposed restricting e-cigarettes to ≤ 2% nicotine to curb youth e-cigarette use, and several states have already set limits to reduce nicotine in e-cigarettes. Prior laboratory studies indicate that higher vs lower nicotine e-cigarettes serve as better substitutes for cigarettes among adult dual users. As such, a restriction on e-cigarette nicotine concentration could undermine the potential for e-cigarettes to substitute for cigarettes and diminish the benefits of a nicotine-limiting standard for cigarettes among dual users. This study is a 12-week double-blind 2 cigarette level (Normal Nicotine vs Very Low Nicotine) x 2 e-cigarette level (High Nicotine vs Low Nicotine) between-subjects factorial trial to investigate how a nicotine-limiting standard for cigarettes affects adult dual users and whether these effects are impacted by constraints on e-cigarette nicotine concentration. Outcome measures include cigarettes per day, cigarette dependence, and toxicant exposure. The research is highly relevant to FDA CTP domains of Addiction and Behavior because it will test whether reducing the nicotine content of cigarettes reduces smoking and dependence, and whether these effects are moderated by the availability of high vs low nicotine e-cigarettes.",[417],"Tobacco Use Disorder",[419,420],"Cigarettes","E-cigarettes","2025-06-23",{"date":423,"type":37},"2025-06-27",{"date":425,"type":37},"2024-11-01",{"date":427,"type":21},"2028-09-30",{"name":43,"class":44},2,{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":434,"acronym":4,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":436,"maxAge":437,"enrollmentInfo":438,"targetDuration":4,"studyType":22,"phases":440,"briefSummary":441,"conditions":442,"keywords":448,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":460},"100592415","a-multi-site-hybrid-type-i-effectiveness-implementation-randomized-trial-of-an-emergency-care-action-plan-for-infants-with-medical-complexity-100592415","NCT06993129","A Multi-Site Hybrid Type I Effectiveness-Implementation Randomized Trial of an Emergency Care Action Plan for Infants With Medical Complexity","Inclusion Criteria:\n\n* Age 0 to 6 months\n* Admitted to the University of Vermont Medical Center, Cincinnati Children's Hospital, Children's Hospital of Philadelphia, or Colorado Children's Hospital Neonatal Intensive Care Unit (NICU),\n* Meets or is expected to meet Children with Medical Complexity status as determined by the treating NICU clinician and defined as \"children with multiple significant chronic health problems including multiple organ systems, which result in functional limitations, high health care needs or utilization, and often require need for, or use of, medical technology.\"\n* Has three or more documented complex chronic conditions (CCCs)\n\nExclusion Criteria:\n\n* Does not have a caregiver participant who agrees to their participation in the study to complete follow-up surveys\n* Does not intend to use the hospital or affiliated sites of which they were recruited from for care during the one-year trial period","0 Months","6 Months",{"count":439,"type":21},500,[24],"Infants with medical complexity (IMC) are a challenging population with more emergency department visits, inpatient stays, and higher healthcare costs than other children. IMC also experience lower quality emergency health care. The PI and team propose to adapt and put into place an emergency care action plan (ECAP) for IMC across four US hospitals, working directly with medical providers and families in each setting. After the tool is made available to providers and families, the PI and team will measure if the ECAP tool helps decrease the number of hospitalizations (primary research outcome) for IMC, as well as if the ECAP is feasible, acceptable, and useable for those using the ECAP over a one-year period.",[443,444,445,446,447],"Chronic Disease Management","Infants Health","Emergency","Utilization, Health Care","Caregiver Stress",[449,450,451],"Children with Medical Complexity","Hybrid Implementation Trial","Health Service Utilization","2025-06-03",{"date":454,"type":37},"2025-06-06",{"date":456,"type":21},"2026-04-01",{"date":458,"type":21},"2031-06-01",{"name":43,"class":44},4,{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":353,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":429},"100528383","preserve--connect-impact-study-of-the-bpc-100528383","NCT06160050","PRESERVE & CONNECT: Impact Study of the BPC","Randomized Control Trial of the Breakthrough Parenting Curriculum: Transforming Trauma Across Generations","(BPC)","Inclusion Criteria:\n\n\\- Parents involved in, or at risk of involvement in, the child welfare system.\n\nExclusion Criteria:\n\n* active psychosis without medication stabilization\n* ongoing major depressive episodes\n* active suicidal ideation\n* active homicidal ideation",{"count":470,"type":21},240,[24],"The PRESERVE \\& CONNECT project is a multi-site randomized control trial of the Breakthrough Parenting Curriculum: Navigating Trauma Across Generations (BPC) in rural and racially and ethnically diverse communities in Vermont and Connecticut.",[474,475],"Child Maltreatment","Trauma","2025-04-14",{"date":478,"type":37},"2025-04-17",{"date":480,"type":37},"2024-02-01",{"date":482,"type":21},"2027-09-20",{"name":43,"class":44},{"id":485,"slug":486,"hasResults":11,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":22,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":45},"100542282","phase-1-lemurs-ssi-evaluation-of-behavioral-incentives-100542282","NCT06340841","LEMURS SSI: Evaluation of Behavioral Incentives","Lived Experiences Measured Using Ring Study: Single Session Intervention to Motivate Behavioral Change","LEMURSSI","Inclusion Criteria:\n\nCurrent undergraduate student in their first year of school own a mobile device\n\nExclusion Criteria:\n\nNone","20 Years",{"count":494,"type":21},200,[94],"The goal of this substudy is to determine if a brief single-session-intervention (SSI) coupled with different incentive strategies to support engaging in wellness-related activities.",[498],"Incentives","2024-03-30",{"date":501,"type":37},"2024-04-02",{"date":503,"type":37},"2024-02-12",{"date":505,"type":21},"2028-05-31",{"name":43,"class":44},""]