[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ohio State University Comprehensive Cancer Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":584},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,76,0,25,[9,41,73,98,116,135,159,176,197,217,244,276,298,322,341,363,390,411,433,453,479,502,521,545,565],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100610277","spine-oncology-registry-100610277",false,"NCT07225491","Spine Oncology Registry","A Prospective Registry of Patients Undergoing Surgical Decompression Followed by Radiation Therapy for Spine Tumors","Inclusion Criteria:\n\n* Diagnosis of primary or metastatic disease to the spine who undergo surgical decompression and stabilization followed by radiation therapy\n\nExclusion Criteria:\n\n* Inability to obtain a standard MRI or CT \u002F CT myelogram for radiation treatment planning and dosimetry\n* Inability to receive radiation treatment.\n* Patients under 18 years of age","ALL","18 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","This is an observational study to evaluate hardware related and oncologic outcomes in adult patients with primary and metastatic spine disease undergoing separation surgery followed by radiation treatment.",[25,26,27],"Spine Tumor","Spine Metastases","Spine Cancer","RECRUITING","2026-08-15",{"date":31,"type":32},"2026-08-18","ACTUAL",{"date":34,"type":32},"2025-11-24",{"date":36,"type":21},"2037-12-31",{"name":38,"class":39},"Ohio State University Comprehensive Cancer Center","OTHER",5,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100631687","phase-4-thrive-study-understanding-how-oral-nicotine-pouches-affect-public-health-100631687","NCT07503925","THRIVE Study: Understanding How Oral Nicotine Pouches Affect Public Health","THRIVE Study: Informing Oral Nicotine Pouch Regulations to Promote Public Health","THRIVE","Inclusion Criteria:\n\n* Age 21 or older\n* Able to read and speak English\n* Willing to abstain from tobacco, nicotine, and marijuana for at least 12 hours prior to study visits\n* Exclusive use of ONPs (other product use \\\u003C10x\u002Fmo).\n* Exhaled CO reading \\\u003C10 ppm\n* Owns a smartphone and can receive SMS text messages with embedded survey links\n* Negative pregnancy test at V1 and V2 (if applicable)\n* Uses ≥1.5 cans of ONPs\u002Fweek\n* Daily use of ONPs for the past 3 months\n* At least half of ONPs used are 6mg nicotine concentration.\n\nExclusion Criteria:\n\n* Non-English speaker\n* Individuals currently pregnant, planning to become pregnant, or breastfeeding are excluded due to potential risks associated with nicotine exposure and study procedures (e.g., blood draws).\n* Individuals with unstable or significant psychiatric conditions are excluded to minimize risk and ensure reliable participation.\n* Individuals actively attempting to quit nicotine use are excluded to avoid ethical concerns and ensure that study participation does not interfere with cessation efforts\n* Non-nicotine users and regular tobacco users are excluded from the clinical trial component to ensure that participants have established use patterns appropriate for assessing ONP use behaviors.",true,"21 Years",{"count":52,"type":21},15,"INTERVENTIONAL",[55],"PHASE4","Although nicotine pouches have been gaining popularity over the last few years, little known about how nicotine pouch users actually use these products.\n\nThis study will be comprised of adults who use nicotine pouches. If eligible, participants will be asked to complete three study visits and participate in two switching periods where participants use study-provided nicotine pouches.",[58],"Tobacco-Related Carcinoma",[60,61,62,63],"Tobacco","Oral Nicotine Pouches","Particle Size","Tobacco Regulation","2026-08-13",{"date":66,"type":32},"2026-08-17",{"date":68,"type":32},"2026-06-26",{"date":70,"type":21},"2027-12-31",{"name":38,"class":39},1,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":80,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":53,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":72},"100604077","early-phase-1-effects-of-a-probiotic-intervention-on-the-gut-and-vaginal-microbiome-in-patients-with-advanced-or-recurrent-ovarian-cancer-undergoing-treatment-with-platinum-chemotherapy-100604077","NCT07144826","Effects of a Probiotic Intervention on the Gut and Vaginal Microbiome in Patients With Advanced or Recurrent Ovarian Cancer Undergoing Treatment With Platinum Chemotherapy","A Randomized, Double-Blind, Placebo Controlled, Study to Investigate Efficacy of a Probiotic Intervention on the Gut and Vaginal Microbiome of Ovarian Cancer Patients Undergoing Treatment With Platinum Chemotherapy","Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written consent form. In patients who do not speak English, ability to have informed consent form translated in their native language and have their native language translator present for consenting process\n* Age \\> 18 years old\n* Patient with advanced (stage II, III or IV) or recurrent ovarian cancer who will receive platinum-based chemotherapy as standard of care (cisplatin, carboplatin containing regimens)\n* Agreeable to participate in all research activities defined in the study\n* Agreeable to not take any other probiotic and\u002For prebiotic supplements outside of study intervention during the study\n* Agreeable to not make significant changes to their diet throughout the course of the study\n* Patients with ileostomy, colostomy are permitted to participate\n\nExclusion Criteria:\n\n* Borderline ovarian tumors\n* Prior allergy or food intolerance to any probiotic product\n* History of chronic inflammation or active structural abnormality of the digestive tract (e.g., inflammatory bowel disease requiring medications, active duodenal or gastric ulcer, complete large or small bowel intestinal obstruction, active fistula)\n* Patients who do not meet laboratory parameters for platinum-based chemotherapy, including absolute neutrophil count (ANC) \\\u003C 1500\n* Known hypersensitivity to any component of study product (Akkermansia muciniphila, Anaerobutyricum hallii, Clostridium beijerinckii, Clostridium butyricum and Bifidobacterium infantis, chicory inulin, magnesium stearate, grape food color, and silica)\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: penicillin, piperacillin, tetracycline, amoxicillin, ampicillin\n* Known hypersensitivity to \\> 4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26\\^Trademark (TM): gentamicin, kanamycin, streptomycin, tetracycline, erythromycin, clindamycin, ampicillin, vancomycin","FEMALE",{"count":82,"type":21},161,[84],"EARLY_PHASE1","This clinical trial evaluates the effects a probiotic intervention has on the gut and vaginal microbiome in patients undergoing chemotherapy for ovarian cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Gut health is also known as the gut microbiome. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. Probiotics are dietary supplements containing live microorganisms that may help keep the gastrointestinal tract healthy. A probiotic intervention during platinum chemotherapy in ovarian cancer patients may impact the gut and vaginal microbiota, quality of life, symptoms, and oncologic outcomes.",[87,88,89,90,91],"Advanced Ovarian Carcinoma","Recurrent Ovarian Carcinoma","Stage II Ovarian Cancer AJCC v8","Stage III Ovarian Cancer AJCC v8","Stage IV Ovarian Cancer AJCC v8",{"date":66,"type":32},{"date":94,"type":32},"2026-03-06",{"date":96,"type":21},"2027-07-09",{"name":38,"class":39},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":53,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":72},"100540364","phase-2-informing-oral-nicotine-pouch-regulations-to-promote-public-health-100540364","NCT06315881","Informing Oral Nicotine Pouch Regulations to Promote Public Health","Inclusion Criteria:\n\n* Read and speak English\n* At least 21 years old\n* Willing to provide informed consent and abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to Phase 1 study visits\n* Willing to attend all study visits and use study ONPs\n* Owns a smartphone and able to receive short messaging service (SMS) text messages with embedded survey link (for daily diary reports of ONP and other tobacco use)\n* Negative pregnancy test produced during Phase 1 visits 1-5 and Phase 2 visit 1 if capable of becoming pregnant\n* Exhaled carbon monoxide (CO) reading \\\u003C 10 (Phase 1)\n* CIGARETTE SMOKERS ONLY: Established cigarette smoker (has smoked at least 100 cigarettes, has smoked daily for at least the past 3 months, now smokes at least 5 cigarettes per day)\n* ST USERS ONLY: Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans\u002Fweek (as in Pickworth et al., 2014)\n\nExclusion Criteria:\n\n* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test before each Phase 1 study visit \\[acute use of usual product and study ONPs\\] and Phase 2 study visit 1 \\[distribution of study ONPs for outpatient ad libitum use\\])\n* Currently engaging in tobacco quit attempt, interested in quitting all tobacco, or planning on quitting all tobacco in the next 3 months\n* Oral or systemic health issues that affect oral microbiome or epithelium, including having fewer than 21 teeth, diabetes mellitus, or autoimmune disease (e.g., rheumatoid arthritis, lupus)\n* CIGARETTE SMOKERS ONLY: Use of non-cigarette tobacco products ≥ 10 of the past 30 days\n* CIGARETTE SMOKERS ONLY: Self-reported diagnosis of lung disease including asthma (if uncontrolled or worse than usual), cystic fibrosis, or chronic obstructive pulmonary disease\n* CIGARETTE SMOKERS ONLY: Roll-your-own cigarette smokers\n* ST USERS ONLY: Use of non-moist-snuff tobacco products ≥ 10 of the past 30 days",{"count":105,"type":21},160,[107],"PHASE2","This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs.",[58],{"date":66,"type":32},{"date":112,"type":32},"2025-01-13",{"date":114,"type":21},"2028-08-31",{"name":38,"class":39},{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":53,"phases":124,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},"100535296","effects-of-tobacco-cut-and-nicotine-form-on-the-abuse-liability-of-moist-snuff-100535296","NCT06249984","Effects of Tobacco Cut and Nicotine Form on the Abuse Liability of Moist Snuff","Inclusion Criteria:\n\n* Adults aged 21 and older who reside in Appalachian counties and surrounding rural areas under the RUCA code 10 classification and use SLT daily for at least 3 months and using 1.5 cans\u002Fweek will be considered for this project\n* Established moist snuff user (has used moist snuff daily for at least the past 3 months, uses at least 1.5 cans\u002Fweek.\n* Age 21 years or older\n* Reside in Appalachian counties and surrounding rural areas under the RUCA code 10 classification\n* Willing to complete 5 study visits and provide informed consent study procedures, including abstaining from all tobacco, nicotine, and marijuana for 12 hours before clinic visits\n* Willing to abstain from nicotine and tobacco products 12-hours before study visit\n* Ability to read and speak English\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant, or breastfeeding (will be verified with a urine pregnancy test at the first session visit)\n* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)\n* History of cardiac event or distress, including but not limited to uncontrolled high blood pressure, chest pain, and shortness of breath, within the past 3 months\n* Working with a cessation counselor, using cessation devices such as Chantix or Wellbutrin, or planning to quit within the next 3 months\n* Severe periodontal or oral lesions",{"count":123,"type":21},80,[125],"NA","This clinical trial tests the effects of tobacco cut and nicotine form on the abuse liability in participants who use moist snuff (smokeless tobacco \\[SLT\\]). Two features of moist snuff that are key targets of manipulation from the tobacco industry and drivers of its addiction potential are length of tobacco cut (long versus fine) and nicotine form (low versus high levels of nicotine in the free-base form). Finer tobacco cuts and higher levels of free-base nicotine (FBN) result in faster, greater nicotine delivery. Researchers want to gain information on how certain characteristics of moist snuff affect how long people use it, how it delivers nicotine, or how much people like it. This clinical trial may provide justifications for local, state, or federal regulations aimed at reducing the appeal and addictiveness of moist snuff.",[58],{"date":66,"type":32},{"date":130,"type":32},"2024-12-20",{"date":132,"type":21},"2028-01-31",{"name":38,"class":39},2,{"id":136,"slug":137,"hasResults":12,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":12,"sex":80,"minAge":18,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":53,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":158,"locationsCount":72},"100645793","a-navigation-program-to-improve-survivorship-support-service-participation-among-non-metastatic-breast-cancer-survivors-100645793","NCT07699991","A Navigation Program to Improve Survivorship Support Service Participation Among Non-metastatic Breast Cancer Survivors","Implementation of a Navigation Program for Breast Cancer Survivors","Inclusion Criteria:\n\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Ages 18+\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Diagnosed with non-metastatic breast cancer\n* GENERAL INCLUSION (PRIMARY OBJECTIVE): Received care at Stefanie Spielman Breast Center\n* COACHING INCLUSION (SECONDARY OBJECTIVE): Referred patients who fall under any of the following:\n\n  * Black and\u002For Hispanic\n  * Ages ≥ 70\n  * Reside in a ZIP code classified as rural by United States Department of Agriculture (USDA) Rural-Urban Commuting Area (RUCA) codes\n\nExclusion Criteria:\n\n* Metastatic breast cancer at time of referral\n* Prisoners or individuals unable to consent\n* Non-English and non-Spanish speakers",{"count":143,"type":21},330,[125],"This clinical trial studies whether a navigation program improves survivorship support service participation among survivors of breast cancer that has not spread from where it first started (primary site) to other places in the body (non-metastatic). Advances in treatment have caused the number of breast cancer survivors to grow. As this number increases, there are reported unmet supportive care needs in this population, including psychological distress and limitations in physical functioning. To address these needs, many cancer centers offer programming on a variety of topics including psychological services, exercise counseling, and nutrition counseling. Research has shown that while interest in these survivorship programs is high, participation remains low, especially among minority women. Navigation is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The navigation program in this trial is specifically focused on helping breast cancer survivors schedule and attend survivorship consultation appointments as well as providing additional support to underserved\u002Fvulnerable patients. A navigation program may be effective in improving survivorship support service participation among non-metastatic breast cancer survivors.",[147,148,149,150,151],"Anatomic Stage 0 Breast Cancer AJCC v8","Anatomic Stage I Breast Cancer AJCC v8","Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","Localized Breast Carcinoma","2026-08-12",{"date":154,"type":32},"2026-08-14",{"date":156,"type":21},"2026-09-01",{"date":70,"type":21},{"name":38,"class":39},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":53,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":171,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":175,"locationsCount":72},"100550536","manipulating-e-cigarette-nicotine-to-promote-public-health-100550536","NCT06448351","Manipulating E-Cigarette Nicotine to Promote Public Health","Inclusion Criteria:\n\n* Current exclusive young adult EC user for at least the past 3 months (confirmed by cotinine testing strip) between 21-24 years old with no\u002Fminimal history of smoking cigarettes (≤ 10 cigarettes in entire life)\n* Current older adult smoker (daily use, ≥ 100 cigarettes in entire life) aged 25-65 with interest in trying an EC\n* Willing to abstain from all nicotine, tobacco products, and marijuana for at least 12 hours for Study 1 and 2 hours for Study 2 before study visits\n* Read, write, and speak English\n\nExclusion Criteria:\n\n* Currently attempting to quit nicotine or tobacco products\n* Currently pregnant (will be verified with urine pregnancy test), planning to become pregnant, or breastfeeding\n* If age 21-24 years old AND use of any tobacco products other than ECs (use of \\>10 cigarettes in entire life; use of \\>10 traditional cigars, cigarillos, or filtered cigars in entire life; use of smokeless tobacco products \\>10 times in entire life; or hookah in the last 30 days).\n* Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease\n* New or unstable cardiovascular disease diagnosed within the past 3 months\n* Use of medications that are inducers of CYP2A6 enzyme such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsion drugs","65 Years",{"count":167,"type":21},375,[125],"This clinical trial explores the manipulation of e-cigarette (EC) nicotine to promote public health. Researchers are trying to understand and gather information about how the strength, form, and structure of nicotine in products play a significant role in their potential for addiction and how they might affect health risks. The information gained from this study may allow researchers to understand how these aspects of nicotine influence the potential for addiction, how people puff on ECs, how the body processes nicotine, and any potential harmful effects it might have on health. Exploring these specific characteristics of nicotine may also determine if an EC product standard could help identify optimal nicotine levels for users.",[58],{"date":154,"type":32},{"date":173,"type":32},"2024-05-20",{"date":114,"type":21},{"name":38,"class":39},{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":165,"enrollmentInfo":183,"targetDuration":4,"studyType":53,"phases":185,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":72},"100646695","the-abuse-liability-of-iqos-heated-tobacco-products-among-adults-who-smoke-100646695","NCT07688304","The Abuse Liability of IQOS Heated Tobacco Products Among Adults Who Smoke","Studying User Sensory Experiences and Smoking Behavior of IQOS Heated Tobacco Products to Improve Harm Reduction Among Adult Cigarette Smokers","Inclusion Criteria:\n\n* Adults 21-65 years\n* Adults who smoke (defined as ≥ 5 days weekly use of either menthol or non-menthol cigarettes over the past 3 months)\n* Willing to provide informed consent and abstain from using nicotine products 12 hours before each visit\n* Willing to bring UBC to each study visit\n* Read, write and speak English\n\nExclusion Criteria:\n\n* Current use of other non-combustible nicotine products (e.g., electronic \\[e\\]-cigarettes, HTPs; \\[defined as ≥ 5 days weekly use in the past 30 days\\])\n* Planning to quit nicotine use and\u002For use of any smoking cessation medication in the past 30 days\n* Current diagnosis of any lung diseases (e.g., asthma, cystic fibrosis, or chronic obstructive pulmonary disease)\n* Self-reported unstable or significant psychiatric conditions (past\u002Fstable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Deaf, hard of hearing, or have a severe motor disability\n* Are currently pregnant, planning to become pregnant, or breastfeeding (urine pregnancy test will be completed at each visit throughout the study)",{"count":184,"type":21},30,[125],"This clinical trial aims to evaluate user sensory experiences and smoking behavior when using IQOS heated tobacco products (HTPs) among adults who smoke cigarettes.",[60],"NOT_YET_RECRUITING","2026-08-05",{"date":191,"type":32},"2026-08-10",{"date":193,"type":21},"2026-08",{"date":195,"type":21},"2027-10",{"name":38,"class":39},{"id":198,"slug":199,"hasResults":12,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":53,"phases":206,"briefSummary":207,"conditions":208,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":216,"locationsCount":72},"100522960","weighted-blanket-use-to-reduce-anxiety-in-oncology-patients-100522960","NCT06089408","Weighted Blanket Use to Reduce Anxiety in Oncology Patients","Weighted Blanket Use in Oncology Patients to Reduce Anxiety","Inclusion Criteria:\n\n* Age 18 years of age and older\n* About to begin either targeted or cytotoxic chemotherapy\n* Able to comprehend and sign a consent form\n* Able to read and complete surveys\n* Alert and oriented\n\nExclusion Criteria:\n\n* Currently using a weighted blanket at home\n* Non-English speaking\n* Peripheral neuropathy\n* Fibromyalgia\n* Open pressure ulcer\n* Recent surgical flap\n* Claustrophobic\n* Weight 45 kg or less",{"count":205,"type":21},114,[125],"This clinical trial compares the effect of using weighted blankets versus regular blankets during first time infusions (e.g. chemotherapy, targeted therapy etc.) to decrease adverse side effects such as anxiety and distress in cancer (oncology) patients. Feeling safe, comforted, and grounded in the world are some of the benefits noted by individuals who use weighted blankets. Deep touch pressure (DTP) has been found to reduce symptoms of stress and anxiety and is defined as a sensation one feels when being hugged, squeezed, or held. DTP affects the nervous system by creating a calming effect which may lower stress and increase feelings of well-being. The use of weighted blankets may help to manage anxiety and distress during chemotherapy or immunotherapy infusions.",[209,210],"Hematopoietic and Lymphoid Cell Neoplasm","Malignant Solid Neoplasm","2026-08-03",{"date":189,"type":32},{"date":214,"type":32},"2023-08-01",{"date":70,"type":21},{"name":38,"class":39},{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":53,"phases":226,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":72},"100420405","phase-1-combining-immunotherapy-salvage-surgery--iort-tx-persistentrecurrent-head--neck-cancer-100420405","NCT04754321","Combining Immunotherapy Salvage Surgery & IORT Tx Persistent\u002FRecurrent Head & Neck Cancer","HNSALV Trial: Combining Immunotherapy With Salvage Surgery and IORT for Treatment of Persistent\u002FRecurrent Head and Neck Cancers","Inclusion Criteria:\n\n* Pathologically confirmed either persistent and\u002F or locoregionally recurrent HNSCC of oral cavity, pharynx, larynx, unknown primary head and neck (H\\&N) squamous cell carcinoma\n* Resectable disease as determined by the surgeon and team\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\\u003C 2\n* At least 18 years of age\n* Adequate hematologic, renal, and hepatic function\n* Must have at least 2 week washout period from prior therapy\n* Willingness and ability to provide informed consent\n* Negative pregnancy test for females of reproductive potential\n* Patients who have undergone therapy for their cancer, such as surgery and\u002For chemotherapy and\u002For radiotherapy and recurred\n* Disease measurable by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria.\n* Prior definitive and palliative chemotherapy will be allowed\n* Prior radiation therapy will be allowed\n* Tumor tissue from resected site of disease must be provided for biomarker analyses, in addition to urine and blood sample as scheduled per protocol\n* White blood cell (WBC) \\>= 2000\u002FuL (obtained within 14 days of randomization)\n* Neutrophils \\>= 1500\u002FuL (obtained within 14 days of randomization)\n* Platelets \\>= 100 x10\\^3\u002FuL (obtained within 14 days of randomization)\n* Hemoglobin \\> 9.0 g\u002FdL (obtained within 14 days of randomization)\n* Serum creatinine =\\\u003C 1.5 x upper limit of normal (ULN) or calculated creatinine clearance (CrCl) \\>= 40 mL\u002Fmin (Cockcroft and Gault or Wright formula may be used according to local practice) (obtained within 14 days of randomization)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x institutional ULN\n* Total Bilirubin =\\\u003C 1.5 x institutional ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\\u003C 3.0 mg\u002FdL)\n* Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for four months after the last dose of pembrolizumab.\n* Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\])\n* Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of four months after the last dose of investigational product\n\nExclusion Criteria:\n\n* Requirement of immunosuppressive therapy within 14 days of randomization\n* Salivary gland carcinomas, lip carcinoma, adenocarcinoma of the skin\n* Prior use of immune checkpoint blockade agent\n* History of human immunodeficiency virus (HIV), hepatitis B, C: Participants who test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection, those who test positive for human immunodeficiency virus (HIV) or have known acquired immunodeficiency syndrome (AIDS)\n* Unresectable disease, as determined by the surgeon and team\n* Subjects with history of grade 3 toxicity with prior immunotherapy\n* Patients with distant metastases\n* Subjects with active autoimmune disease\n* Breastfeeding women\n* Additional prior malignancy within the previous 3 years (treated or untreated, except for skin carcinomas treated with excision alone and carcinoma in situ of the cervix)\n* Palliative radiotherapy less than 14 days prior to first dose of study drug\n* Any history of hypersensitivity to any of the trial medications\n* Poorly controlled or serious medical or psychiatric illness likely to interfere with participation and\u002For compliance in this clinical trial\n* Prisoners or subjects who are involuntarily incarcerated\n* Patients not available for follow-up\u002Ffuture contact as defined in the ICF\n* Note: Patients on this protocol are not excluded from participation in other clinical trials",{"count":225,"type":21},45,[227],"PHASE1","This phase I trial is to find out the possible side effects of pembrolizumab and radiation therapy before and during surgery in treating patients with head and neck squamous cell cancer that remains despite treatment (persistent) or has come back (recurrent). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays or protons to kill tumor cells and shrink tumors. Giving pembrolizumab and radiation therapy before and during surgery may kill more tumor cells.",[230,231,232,233,234,235],"Head and Neck Carcinoma of Unknown Primary","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Pharyngeal Squamous Cell Carcinoma","Resectable Head and Neck Squamous Cell Carcinoma","2026-07-23",{"date":238,"type":32},"2026-07-24",{"date":240,"type":32},"2022-05-12",{"date":242,"type":21},"2026-12-31",{"name":38,"class":39},{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":53,"phases":253,"briefSummary":254,"conditions":255,"keywords":267,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":275,"locationsCount":72},"100640818","studying-the-workflow-of-the-american-college-of-surgeons-geriatric-surgery-program-to-improve-clinical-outcomes-in-older-adults-undergoing-surgery-at-the-james-cancer-hospital-100640818","NCT07606287","Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital","Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital","Inclusion Criteria:\n\n1. Patient records for adults aged 65 years or older\n2. Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period\n3. Patient records with data available in institutional electronic health record or institutional data systems\n4. Clinical staff age 18 years or older who are employed or credentialed at The Ohio State University Wexner Medical Center and work within clinical areas affected by ACS Geriatric Surgery Verification implementation\n\nExclusion Criteria:\n\n1. Patient records for encounters occurring only at outside institutions or non-James hospitals within the enterprise\n2. Patient records missing all primary outcome fields after data quality checks\n3. Clinical staff who are trainees, including medical students, physician assistant students, nursing students, resident physicians, or fellows\n4. Clinical staff whose employment, visa, or institutional status would make participation sensitive under institutional policy, if applicable",{"count":252,"type":21},4000,[125],"This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery.\n\nOlder adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home.\n\nThe ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes.\n\nThe results may help improve surgical care workflows for older adults undergoing cancer surgery.",[256,257,258,259,260,261,210,262,263,264,265,266],"Breast Carcinoma","Malignant Digestive System Neoplasm","Malignant Female Reproductive System Neoplasm","Malignant Genitourinary System Neoplasm","Malignant Head and Neck Neoplasm","Malignant Nervous System Neoplasm","Malignant Thoracic Neoplasm","Skin Neoplasm","Soft Tissue Neoplasm","Central Nervous System Neoplasm","Endocrine Gland Neoplasms",[268,269],"geriatric surgery verification","oncogeriatrics","2026-07-22",{"date":236,"type":32},{"date":273,"type":21},"2026-11-15",{"date":70,"type":21},{"name":38,"class":39},{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":53,"phases":284,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":72},"100636358","impact-of-novel-vs-usual-brand-menthol-cigarettes-on-abuse-liability-100636358","NCT07564648","Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability","Inclusion Criteria:\n\n* Aged 21 years or older\n* Currently smoke cigarettes daily (≥ 5 cigarettes\u002Fday) for at least the past 6 months, and their usual brand is menthol cigarettes\n* Willing to provide informed consent\n* Willing to abstain from all nicotine, tobacco, and smoked cannabis products for approximately 12 hours prior to each study visit\n* Own and regularly use a functional smartphone compatible with study procedures (e.g., completing daily assessments)\n* Willing to complete two weeks of daily assessments involving use of their usual brand menthol cigarettes and the study product\n* Able to read, speak, and understand English\n\nExclusion Criteria:\n\n* Current diagnosis of any significant lung diseases (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis)\n* History of a cardiac event or episode of cardiac distress (e.g., heart attack, hospitalization for chest pain) within the past 3 months\n* Currently pregnant, planning to become pregnant during the study period, or currently breastfeeding\n* Self-reported use of any non-cigarette nicotine or tobacco product (e.g., e-cigarettes, cigars, oral nicotine products) or cannabis on more than 10 days in the past 30 days\n* Self-reported current participation in a smoking cessation program or intention to quit smoking in the next 3 months\n* Self-reported difficulty with blood draws",{"count":283,"type":21},48,[125],"This randomized, double-blind, crossover human laboratory study compares the abuse liability of cigarettes containing menthol and non-menthol cigarette variants, using the participant's usual brand menthol cigarette as a within-subject reference. Participants complete standardized laboratory smoking sessions, behavioral economic tasks, and a naturalistic observational period. The study examines differences in nicotine delivery, smoking behavior, and subjective effects across cigarette types in laboratory and real-world contexts.",[287,288],"Cigarette Addiction","Tobacco Use Disorder",[287,290],"Cigarette","2026-07-21",{"date":270,"type":32},{"date":294,"type":21},"2026-07-27",{"date":296,"type":21},"2029-09-30",{"name":38,"class":39},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":80,"minAge":305,"maxAge":306,"enrollmentInfo":307,"targetDuration":4,"studyType":53,"phases":309,"briefSummary":310,"conditions":311,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":321,"locationsCount":72},"100648516","web-based-lifestyle-program-mhealth-and-ema-intervention-to-improve-weight-loss-in-rural-stage-i-iii-postmenopausal-breast-and-endometrial-cancer-survivors-hero-c-trial-100648516","NCT07723235","Web-based Lifestyle Program, mHealth and EMA Intervention, to Improve Weight Loss in Rural Stage I-III Postmenopausal Breast and Endometrial Cancer Survivors, HERO-C Trial","Health Engagement for Rural Ohio Cancer Survivors (HERO-C)","Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 25kg\u002Fm\\^2\n* Age: 40-69 years\n* 1-5 years post-diagnosis of stage I-III postmenopausal breast cancer or stage I-III endometrial cancer\n* No known evidence of recurrence (local or distant) or second, primary cancer\n* No prior history of new other malignancy since their breast or endometrial cancer diagnosis (other than non-melanoma skin cancer)\n* Not currently participating in any weight loss programs, no personal trainer, and not meeting the physical activity guidelines\n* No use of any anti-obesity medications in the last 6 months and no plan to start anti-obesity medications during the study period\n* The ability to walk two blocks without a walker or cane\n* The ability to speak and read English\n* Have access to internet with a computer, tablet, or smart phone\n* Live in rural counties in Ohio and not planning to move away during the study\n* Are not pregnant, breastfeeding or less than 12-month post-partum and do not plan to become pregnant during the study\n\nExclusion Criteria:\n\n* Severe medical conditions, such as unstable cardiovascular disease or digestive disorders, that would preclude physical activity and dietary intervention\n* Lack of physician clearance if determined necessary by the Physical Activity Readiness Questionnaire (PAR-Q+)\n* Acute physical limitations for unsupervised exercises at home\n* Unable to give informed consent","40 Years","69 Years",{"count":308,"type":21},90,[125],"This clinical trial identifies the needs and preferences of rural stage I-III postmenopausal breast and endometrial cancer survivors and evaluates the impact of an adaptive, online program, mobile (m)Health + ecological momentary assessment (EMA) intervention, on lifestyle modification and their weight loss efforts. Obesity, a condition marked by an abnormally high, unhealthy amount of body fat, is associated with lower physical and psychological well-being, higher risk of recurrence, and higher cancer-specific and all-cause mortality (number of deaths). Lifestyle factors, such as low physical activity and unhealthy diet, are the main contributors to obesity that are modifiable. Lifestyle weight loss programs focusing on modifiable factors can improve cancer-specific survival and many aspects of health, but access to these programs can be challenging in rural settings. A remote lifestyle program, adapted to individual goals and needs, may help promote healthy behaviors, improve cancer outcomes, and reduce disease burden in stage I-III postmenopausal breast and endometrial cancer survivors.",[148,149,150,312,313,314,315],"Endometrial Carcinoma","Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage II Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","2026-07-20",{"date":236,"type":32},{"date":319,"type":21},"2026-10-10",{"date":70,"type":21},{"name":38,"class":39},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":4,"studyType":53,"phases":331,"briefSummary":332,"conditions":333,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":339,"leadSponsor":340,"locationsCount":72},"100647226","phase-1-dce-mri-for-neoadjuvant-treatment-assessment-in-patients-with-borderline-resectable-pancreatic-cancer-100647226","NCT07705919","DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer","DCE-MRI-Informed Neoadjuvant Chemotherapy for Borderline Resectable Pancreatic Cancer","Inclusion Criteria:\n\n* Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information\n* Age ≥ 18 years at the time of consent\n* Patients have Eastern Cooperative Group (ECOG) performance status of 0-2\n* Histological or cytological evidence of pancreatic adenocarcinoma\n* Patients must have borderline resectable primary tumor per National Comprehensive Cancer Network (NCCN) definitions version 2.2025 based on contrast-enhanced CT or MRI (CT or MRI without contrast as part of positron emission tomography \\[PET\\]\u002FCT or PET\u002FMRI is NOT acceptable; CT or MRI with contrast as part of PET\u002FCT or PET\u002FMRI is acceptable) of the chest, abdomen, and pelvis, where borderline resectable is defined as all of the following:\n\n  * Solid tumor involvement of ≤ 180° with the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery).\n  * Solid tumor involvement of \\> 180° with the portal vein and\u002For superior mesenteric vein, and a patent portal vein\u002Fsplenic vein confluence.\n  * Solid tumor contact with the inferior vena cava.\n  * Absence of metastatic disease\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 for solid tumors within 28 days prior to registration\n* Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer\n* Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL (obtained within 28 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm3 (100 × 109\u002FL) (obtained within 28 days prior to registration)\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL (obtained within 28 days prior to registration)\n* Aspartate transaminase (AST), serum glutamic-oxaloacetic transaminase (SGOT), alanine transaminase (ALT), serum glutamic-pyruvic transaminase (SGPT) ≤ 3 × upper limit of normal range (ULN) (obtained within 28 days prior to registration)\n* Total bilirubin ≤ 2 × ULN (obtained within 28 days prior to registration)\n* Females of childbearing potential must have a negative pregnancy test (serum or urine) within 3 days prior to registration\n* Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study, and for 6 months after the last dose of study drug(s). Males must be willing to abstain from vaginal intercourse or to use an effective method(s) of contraception from initiation of treatment, during the study, and for 3 months after the last dose of study drug(s)\n* As determined by the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n* History of HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial\n* Co-enrollment on a non-interventional therapeutic trial is allowed. This includes observational trials and biomarker collection trials\n\nExclusion Criteria:\n\n* Evidence of distant metastasis\n* History of significant uncontrolled cardiovascular disease. Significant cardiac disease includes second\u002Fthird degree heart block; significant ischemic heart disease; poorly controlled hypertension; congestive heart failure of the New York Heart Association (NYHA) Class II or worse (slight limitation of physical activity; comfortable at rest, but ordinary activity results in fatigue, palpitation, or dyspnea)\n* History of arrhythmia that is symptomatic or requires treatment. However, patients with atrial fibrillation or flutter controlled by medication are not excluded from participation in the trial\n* Patient with a history of allergy or hypersensitivity to any of the study drugs or any of their excipients\n* Pregnant or lactating\n\n  * NOTE: breast milk cannot be stored for future use while the mother is being treated in this study\n* Patient with any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigators' judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study, or compromise compliance with the protocol (e.g., chronic active hepatitis, active untreated or uncontrolled fungal, bacterial, or viral infections, etc.)\n* No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free and treatment-free for at least two years\n* Patient who is unwilling or unable to comply with study procedures",{"count":330,"type":21},50,[227,107],"This clinical trial tests how well dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) with standard clinical evaluation works to assess treatment response for patients with pancreatic cancer that may be able to be removed by surgery (borderline resectable). Borderline resectable pancreatic cancer (BRPC) is a certain type of pancreatic cancer that involves the arteries or veins near the pancreas. With the right treatment before surgery, it can be removed (resected) successfully. An MRI (magnetic resonance imaging) scan creates clear images of the structures inside the body using a large magnet, radio waves, and a computer. DCE-MRI can be used to calculate the blood perfusion. Blood perfusion can show disease status. Using DCE-MRI as part of standard clinical evaluation may provide a more accurate treatment response assessment for patients with BRPC.",[334],"Borderline Resectable Pancreatic Ductal Adenocarcinoma","2026-07-10",{"date":337,"type":32},"2026-07-15",{"date":156,"type":21},{"date":70,"type":21},{"name":38,"class":39},{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":17,"minAge":347,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":53,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":72},"100606317","strategies-for-optimizing-a-mailed-fit-program-in-appalachia-100606317","NCT07173985","Strategies for Optimizing a Mailed FIT Program in Appalachia","Inclusion Criteria:\n\n* Resident of an Appalachian county\n* Medical visit at a participating health system in the past two years\n* Average-risk for colorectal cancer\n* Not currently within colorectal cancer screening guidelines\n\nExclusion Criteria:\n\n\\-","45 Years","74 Years",{"count":350,"type":21},550,[125],"The proposed study is examining strategies for optimizing mailed fecal immunochemical test (FIT) programs. In doing so, it will assess the efficacy of two promising strategies, FIT kit materials and patient navigation delivery mode. These strategies may help to improve colorectal cancer screening rates.",[354],"Colonic Neoplasms","2026-07-08",{"date":357,"type":32},"2026-07-09",{"date":359,"type":32},"2026-01-20",{"date":361,"type":21},"2028-07-31",{"name":38,"class":39},{"id":364,"slug":365,"hasResults":12,"nctId":366,"briefTitle":367,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":369,"targetDuration":4,"studyType":53,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":72},"100627366","a-pilot-study-to-evaluate-the-effectiveness-of-focused-massage-on-pain-mobility-and-quality-of-life-during-radiation-treatment-for-patients-with-breast-cancer-100627366","NCT07447700","A Pilot Study to Evaluate the Effectiveness of Focused Massage on Pain, Mobility, and Quality of Life During Radiation Treatment for Patients With Breast Cancer","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Diagnosis of breast cancer\n3. Treatment plan for curative intent radiation at SSBC\n4. Radiation treatment frequency can be daily, every other day, and twice weekly\n5. Agreeable to and available for focused chair massages post-radiation treatments during the prescribed treatment period\n\nExclusion Criteria:\n\n1. Patients with recurrent disease (breast cancer)\n2. Patients treated palliatively with radiation treatments\n3. Inability to read and\u002For understand English (consent and questionnaires in English)\n4. Patients with documented cognitive disorder that limits the ability to independently read, understand, and\u002For complete the survey measures; i.e. dementia, Alzheimer's\n5. Patients with major psychiatric disorders not controlled by medication or other psychiatric treatments",{"count":370,"type":21},55,[125],"The goal of this interventional study is to to evaluate the effectiveness and acceptability of a focused upper body massage when offered after radiation treatments to participants diagnosed with breast cancer. Given the prevalence of musculoskeletal complaints during radiation therapy delivery and acknowledging the emotional stress associated with breast cancer diagnosis and treatment, the aims of this pilot study are to: 1) evaluate the effectiveness of a focused upper body massage, available after radiation treatments, on patient's muscle and joint achiness and disability\u002Fsymptoms of the upper extremities; 2) evaluate the effectiveness of a focused chair massage, available after radiation treatments on health-related quality of life; 3) assess the need for repeating the pre-radiation simulation process and revising the established treatment plan; and 4) and evaluate patient acceptability of the massages offered during the course of radiation treatment.",[374,375],"Breast Cancer","Radiation Therapy Patient",[377,378,379,380,381],"breast cancer","radiation therapy","muscle and joint achiness","quality of life","re-simulation","2026-06-30",{"date":384,"type":32},"2026-07-02",{"date":386,"type":32},"2026-04-01",{"date":388,"type":21},"2027-08-30",{"name":38,"class":39},{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":165,"enrollmentInfo":397,"targetDuration":4,"studyType":53,"phases":398,"briefSummary":399,"conditions":400,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"locationsCount":72},"100573038","phase-1-bzlf1-peptide-vaccine-osu-2131-with-qs-21-for-the-prevention-of-epstein-barr-virus-related-cancer-in-patients-awaiting-solid-organ-transplants-100573038","NCT06741072","BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants","A Phase 1B Double Blinded Randomized Trial Evaluating Safety, Tolerability, and Immune Response of OSU-2131 a BZLF1 Peptide Vaccine With Stimulon™ QS-21 Solution Adjuvant in Healthy Volunteers and Patients Awaiting Solid Organ Transplantation","Inclusion Criteria:\n\n* Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\\*08:01\n* Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive\n* Subjects must be seronegative for HIV\n* Subjects must be seronegative for hepatitis B and C\n* Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits\n* Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal\n* Platelets above the lower limit of normal (LLN)\n* Basophils, lymphocytes, and monocytes must be within 1.2 x upper limit of normal (ULN) or 0.8 x LLN and considered not clinically significant by the investigator\n* Total creatine kinase (CK) laboratory values \\\u003C 1.25 x the upper limit of normal (according to the normal reference ranges of the Ohio State University \\[OSU\\] laboratory) at baseline (screening \\& pre-study visit) and considered not clinically significant by the investigator\n* Subjects must not be taking antiviral therapy\n* Must be ≥ 18 years of age and ≤ 65 years of age and willing to either use an effective method of contraception or abstain from sexual activity for at least 3 months following the last dose of vaccination\n* Female of childbearing potential must have a negative serum pregnancy test prior to the first study drug\u002Fplacebo (PBS) administration\n* Agree not to receive any other investigational drug while enrolled in this study\n* Provide written informed consent according to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) and local regulations\n* Following successful completion of safety evaluation for the phase 1 dose escalation phase of this trial in healthy volunteers and review of this data by the Sponsor and Food and Drug Administration (FDA), we plan to enroll a second cohort of patients awaiting solid organ transplantation (SOT). We will recruit patients with end stage renal disease (ESRD) who are awaiting kidney transplantation. ESRD is defined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease (Acosta-Ochoa et al, J Clin Med, 8(9):1323, 2019). KDIGO defines ESRD as: stage 4: severe reduction in glomerular filtration rate (GFR) (15 to 29 mL\u002Fmin); stage 5: renal failure (GFR less than 15 mL\u002Fmin). Patients will qualify for ESRD \u002F kidney transplantation per need for maintenance dialysis due to one or more of the criteria related to renal insufficiency: volume overload, metabolic acidosis, electrolyte disturbance, drug toxicity, etc. Patients will be regularly undergoing hemodialysis or peritoneal dialysis for metabolic support. Patients will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes\n\nExclusion Criteria:\n\n* Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion\n* History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)\n* History of immune suppression or autoimmune disorder\n* Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable\n* Pregnant or breastfeeding subjects\n* For patient enrollment on the second cohort, \"patients awaiting SOT\", we will consider patients awaiting kidney transplantation who are receiving maintenance renal replacement therapy (dialysis). Most patients on routine renal replacement therapy (dialysis) will present with stable chemistry, acid base balance, volume status and clear mental status. For patients who are non-compliant with routine dialysis, laboratory abnormalities and acid base, volume status can become abnormal. Specific dose limiting toxicity (DLT) criteria that may relate to patients with ESRD include laboratory parameters that may altered due to missed dialysis session(s). Most laboratory abnormalities in such patients can be corrected by restarting dialysis or blood transfusions. Outside these specific variables, we do not expect to see specific DLT criteria for patients with ESRD on this study. Metabolic derangement such as acid base imbalance, hyperkalemia and volume overload as a result of missing dialysis session. Study stopping rule for subjects awaiting organ transplant: Occurrence of this event in two or more subjects should result in study pause. Patients who are unable to adhere to routine dialysis will be excluded from the study if they have any unstable medical conditions which the investigator believes would preclude participation in the study. These conditions include but are not limited to cardiorenal and hepatorenal syndromes",{"count":370,"type":21},[227],"This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause in patients awaiting solid organ transplants.",[401,402,403,404,405],"Chronic Kidney Disease, Stage 4","Chronic Kidney Disease, Stage 5","EBV-Related Lymphoproliferative Disorder","EBV-Related Malignant Neoplasm","Post-Transplant Lymphoproliferative Disorder",{"date":384,"type":32},{"date":408,"type":32},"2026-06-28",{"date":70,"type":21},{"name":38,"class":39},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":426,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":432},"100252131","hairy-cell-leukemia-patient-data-registry-100252131","NCT02560883","Hairy Cell Leukemia Patient Data Registry","Clinical Research in Hairy Cell Leukemia: Surveillance and Documentation of Clinical Outcomes in a Rare Form of Adult Leukemia","HCL-PDR","Inclusion:\n\n* Patients with classic hairy cell leukemia\n* Patients with the variant of hairy cell leukemia.\n\nExclusion:\n\n* Children are excluded from the study, since Hairy Cell Leukemia wasn't described in children.",{"count":420,"type":21},5000,"The overall objective is to develop a clinical data registry that can be used to facilitate research with the ultimate goal of reducing the morbidity and\u002For mortality and improving the quality of life of patients diagnosed or living with hairy cell leukemia. With approximately 1,000 new cases of this rare disease identified in the US each year, HCL represents 2% of all cases of leukemia in adults. Considering the rarity of this chronic leukemia, the Hairy Cell Leukemia Foundation (HCLF), in partnership with investigators from its Centers of Excellence, seeks to develop a registry to help researchers identify new trends in outcomes, recognize the most effective treatments, discover previously unknown complications of the disease, and design clinical trials for new therapies.",[423],"Leukemia, Other",[425],"Hairy Cell",{"date":384,"type":32},{"date":428,"type":32},"2013-01-02",{"date":430,"type":21},"2030-12-31",{"name":38,"class":39},8,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":53,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":72},"100574765","oral-nicotine-pouches-versus-nicotine-replacement-therapy-to-reduce-cigarette-use-for-smokers-in-rural-appalachia-100574765","NCT06763536","Oral Nicotine Pouches Versus Nicotine Replacement Therapy to Reduce Cigarette Use for Smokers in Rural Appalachia","Testing Oral Nicotine Pouches to Reduce Smoking-Related Cancer in Rural Appalachia","ARISE","Inclusion Criteria:\n\n* Read and speak English\n* 21 years or older\n* Smoke ≥ 5 cigarettes per day for the past year\n* Willing to use Oral Nicotine Pouches (ONP) or Nicotine Replacement Therapy (NRT)\n* Live in a rural Appalachian County\n* Have a smartphone and\u002For willing to use a smartphone for study purposes (smartphones may be provided to participants for study purposes only)\n* Willing to blow air into a handheld study device\n* If capable of becoming pregnant, verbal confirmation of not being pregnant based on urine pregnancy test results\n\nExclusion Criteria:\n\n* Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation\n* Use of ONPs in past 3 months\n* Use of Nicotine Replacement Therapies in past 3 months\n* Use of other tobacco products \\> 10 days\u002Fmonth\n* Unstable or significant medical condition\n* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)\n* History of cardiac event or distress within the past 3 months\n* Live in same household as another study participant.\n* Currently pregnant, planning to become pregnant within 6 months, or breastfeeding",{"count":442,"type":21},1000,[125],"This clinical trial compares the use of oral nicotine pouches to nicotine replacement therapy, consisting of nicotine patches and lozenges, to reduce cigarette use in smokers living in rural Appalachia. The lung and oral cancers that plague Appalachia are fueled by cigarette smoking. Oral nicotine pouches which contain nicotine but no tobacco leaf, present a new opportunity to reduce cancer risk among Appalachian adults who smoke. Oral nicotine pouches and nicotine replacement therapy may work well to reduce cigarette use for smokers in rural Appalachia.",[446],"Cigarette Smoking-Related Carcinoma",{"date":382,"type":32},{"date":449,"type":32},"2025-06-13",{"date":451,"type":21},"2028-12-31",{"name":38,"class":39},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":53,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":474,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":478,"locationsCount":134},"100449773","phase-1-papaverine-in-combination-with-chemoradiation-for-the-treatment-of-stage-ii-iii-non-small-cell-lung-cancer-100449773","NCT05136846","Papaverine in Combination With Chemoradiation for the Treatment of Stage II-III Non-small Cell Lung Cancer","A Phase I Trial Targeting Mitochondrial Metabolism With Papaverine in Combination With Chemoradiation for Stage II-III Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* All prior treatment-related toxicities must be Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0) =\\\u003C grade 1 (except alopecia) at the time of enrollment\n* Absolute neutrophil count \\>=1.5 x 10\\^9\u002FL\n* Hemoglobin \\>= 9 g\u002FdL\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Creatinine \\\u003C 1.5 mg\u002FdL or calculated creatinine clearance\\* \\>= 50 mL\u002Fmin or 24-hour urine creatinine clearance \\>= 50 mL\u002Fmin\n\n  * Calculated by the Cockcroft-Gault formula •\\>= 18 years old\n* Non-small cell lung cancer (NSCLC), histologically and\u002For cytologically proven\n* Clinical American Joint Committee on Cancer (AJCC) stage II-III NSCLC (T1-4N0-3M0) and select patients with stage IV oligometastatic disease.\n\n  * For patients with oligometastatic disease (up to 5 total sites of disease) for whom definitive CRT or RT to the primary and regional lymph nodes is recommended by the multidisciplinary team, each individual metastatic tumor would be considered an additional site of disease with the exception of brain metastases. Up to 10 brain metastases would be considered as 1 site.\n  * Patients with oligometastatic disease will be allowed to receive adjuvant systemic therapy at the discretion of the medical oncologist and additional local therapy to metastatic sites at the discretion of the multidisciplinary team\n* Patients must be considered unresectable or medically-inoperable if stage II-III NSCLC\n\n  * Patients with a local or regional recurrence following surgical resection for whom definitive CRT or RT to disease in the chest is recommended by the multidisciplinary team will be considered eligible\n* Patients must have fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)-computed tomography (CT) scan (or CT chest\u002Fabdomen\u002Fpelvis with IV contrast), and magnetic resonance imaging (MRI) brain with IV contrast (preferred) or CT scan of the brain with contrast. Non-contrast MRI scans of the chest\u002Fabdomen\u002Fpelvis or brain are permitted for workup if patient has allergy to CT contrast or renal insufficiency\n* Patients must have vital signs, history\u002Fphysical examination, laboratory studies (complete blood count \\[CBCP\\] with differential, chemistries including liver function tests, creatinine clearance (CrCl) assessment; pregnancy test if needed within 14 days of registration)\n* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* No history of complete atrioventricular block, hepatic dysfunction (e.g. cirrhosis), glaucoma, or priapism\n* Patients must be a minimum of 3 weeks from thoracotomy (if performed) and well-healed before starting treatment\n* Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of registration. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment\n* Nursing women may participate only if nursing is discontinued, due to the possibility of harm to nursing infants from the treatment regimen\n* Women\u002Fmen of reproductive potential must be counselled on contraception\u002F abstinence while receiving the study treatment\n\n  * Women of childbearing potential are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the study duration, and until 6 months after the last dose of radiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 6 months after completion of study drug administration\n* For patients planning to undergo CRT, patient is suitable to receive standard chemotherapy per treating medical oncologist with radiation during study treatment\n\nINCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n•Patients must consent to participate in the main part of this study and be enrolled into the expansion cohort, or consent to participate in the main part of this study and also consent to participate in the optional MRI Imaging study\n\nExclusion Criteria:\n\n* Patients with history of pneumonectomy\n* History of active connective tissue disease (scleroderma) or idiopathic pulmonary fibrosis\n* History of previous radiation therapy which would result in overlapping radiation fields\n* Subjects who are breast-feeding and plan to continue breast-feeding during therapy, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately\n* Hepatic insufficiency resulting in jaundice, or not meeting laboratory values above (albumin, total bilirubin, AST\u002FALT)\n* Patients enrolled into the expansion cohort must be able to complete the MRI Sub-study, or at a minimum attempt the first scan of the MRI Sub-study\n* Any serious and\u002For unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the treating physicians. This could include severe, active co-morbidities such as:\n\n  * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acquired immune deficiency syndrome (AIDS) based upon the current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive\n  * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration\n* Patients who are presently receiving nitrates or nitroglycerin, or have received these medications within 30 days of day 1 of protocol treatment\n* Patients who are currently taking Sildenafil should agree to discontinue use for 2 days prior to initiation of papaverine, during the duration of study, and for 2 days after last dose of papaverine\n\nEXCLUSION CRITERIA FOR MRI IMAGING SUB-STUDY:\n\n* Any medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, pregnancy, nursing mothers, weight greater than 350 pounds)\n* Severe anxiety\u002Fclaustrophobia related to MR imaging despite medications to relieve anxiety\u002Fclaustrophobia\n* Patients who use supplemental oxygen and are not able to stop their oxygen for up to a few hours at a time, or who use oxygen because they have breathing when they are laying down",{"count":461,"type":21},28,[227],"This phase I trial finds out the best dose, possible benefits and\u002For side effects of papaverine when given together with chemoradiation intreating patients with stage II-III non-small cell lung cancer. Papaverine targets mitochondrial metabolism to decrease the cancer growth process. Giving papaverine with chemoradiation may work best to treat patients with non-small cell lung cancer.",[465,466,467,468,469,470,471,472,473],"Locally Advanced Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIA Lung Cancer AJCC v8","Stage IIB Lung Cancer AJCC v8","Stage III Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8","Stage IIIC Lung Cancer AJCC v8","Unresectable Lung Non-Small Cell Carcinoma",{"date":382,"type":32},{"date":476,"type":32},"2021-12-06",{"date":242,"type":21},{"name":38,"class":39},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":80,"minAge":18,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":53,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":134},"100491336","feasibility-study-of-biobehavioral-stress-reduction-intervention-in-patients-with-triple-negative-breast-cancer-100491336","NCT05677802","Feasibility Study of Biobehavioral Stress Reduction Intervention in Patients With Triple Negative Breast Cancer","Examining the Feasibility of Implementing a Biobehavioral Stress Reduction Program in Triple Negative Breast Cancer Patients","Inclusion Criteria:\n\n* Age \\>=18 years\n* Untreated newly diagnosed triple negative breast cancer\n* Stages I-III\n\nExclusion Criteria:\n\n* Prisoners\n* Male\n* Identifying as American Indian, Alaska Native, Asian, Native Hawaiian or Other Pacific Islander\n* Individuals not able to speak and understand English\n* Known personal history of ductal carcinoma in situ (DCIS) or invasive breast cancer\n* Stage IV breast cancer",{"count":487,"type":21},40,[125],"This clinical trial aims to see if patients with triple negative breast cancer can complete a biobehavioral stress reduction program that also addresses health related social needs (e.g., utilities, transportation, etc.). The stress reduction program is over ten weeks and includes stress reduction (e.g., progressive muscle relaxation), coping, problem solving, communication, and social support. Health related social needs will be evaluated at the beginning of the study, and referrals will be made to social work to help address those needs. The study will examine stress as reported by the patients and also use biological markers.",[148,149,150,491,492,493],"HER2-Negative Breast Carcinoma","Hormone Receptor-Negative Breast Carcinoma","Triple-Negative Breast Carcinoma","2026-06-24",{"date":496,"type":32},"2026-06-29",{"date":498,"type":32},"2022-12-14",{"date":500,"type":21},"2027-06-30",{"name":38,"class":39},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":49,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":53,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":520,"locationsCount":72},"100637303","phase-1-comparative-evaluation-of-nicotine-analogs-100637303","NCT07585006","Comparative Evaluation of Nicotine Analogs","CENA","Inclusion Criteria:\n\n* Aged 21 years or older\n* Current adult EC user for at least the past 3 months (confirmed by cotinine testing strip)\n* Willing and able to provide informed consent\n* Willing to abstain from using any nicotine, tobacco, or marijuana products for 12 or more hours prior to the three lab visits\n* Able to read, write, and speak English\n\nExclusion Criteria:\n\n* Currently attempting to quit nicotine or tobacco products\n* Use of other tobacco or nicotine products \\> 10 days in the past month\n* Have had a recent cardiac event or distress (defined as occurring within the previous 3 months)\n* Have had a recent serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, asthma, or lung cancer) (defined as occurring in the previous 30 days)\n* Currently pregnant, planning to become pregnant, or breastfeeding (verified with urine pregnancy test)",{"count":510,"type":21},70,[227],"This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults. Though progress has been made in regulating nicotine containing products, some companies have shifted toward producing products containing nicotine analogs. ECs are battery-powered electronic devices designed to atomize a nicotine (the poisonous chemical found in tobacco)-containing liquid solution for inhalation in a manner that simulates smoking a tobacco cigarette. When nicotine enters the body, it causes an increased heart rate and use of oxygen by the heart, and a sense of well-being and relaxation. Nicotine analogs are compounds that are similar to nicotine in their chemical structure. Some nicotine analogs have been shown to have nicotine-like effects; however, more research is needed to prove they function similarly to nicotine and\u002For have similar effects. Comparing EC user preferences and smoking behaviors of nicotine analogs to nicotine may help improve the understanding of nicotine analog addictiveness.\n\nAdditionally, combustible cigarette smoking is well-known to have deleterious effects on cardiovascular health. High blood pressure is one of the major health consequences of cigarette smoking and can increase the risk of hypertension, heart attack, and stroke. Although ECs have been marketed as a less harmful alternative to cigarette smoking, clinical trials have shown that vaping ECs can also lead to acute increases in blood pressure and heart rate. Nicotine can alter vascular reactivity by promoting the release of vasoconstrictors and suppressing the production of vasodilators. No research has examined how the synthetic nicotine in ECs affects hemodynamics, vascular health, and endothelial function. Assessing acute cardiovascular responses to nicotine analogs is therefore critical to enhancing our understanding of the potential cardiovascular risks associated with vaping ECs containing synthetic nicotine.",[58,514],"Addiction","2026-06-23",{"date":68,"type":32},{"date":518,"type":32},"2026-05-29",{"date":242,"type":21},{"name":38,"class":39},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":72},"100609546","studying-off-label-insurance-coverage-for-patients-with-cutaneous-cancers-a-filter-observational-study-100609546","NCT07215988","Studying Off Label Insurance Coverage for Patients With Cutaneous Cancers a \"Filter\" Observational Study","Inclusion Criteria:\n\n* \\* MERKEL CELL CARCINOMA\n\n  * Signed informed consent\n  * Pathology report confirming Merkel at the time of screening\n  * Stage II, III or IV resectable (criteria based on Merkel Cell carcinoma TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * Planned treatment with immunotherapy. Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB NEUROENDOCRINE (PRL 8149)\n\n    * 2 cycles will be given prior to surgery (=12 weeks).\n\n      * MUCOSAL MELANOMA\n  * Signed informed consent\n  * Pathology report confirming mucosal melanoma at the time of screening\n  * Stage III or IV resectable (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * SOC (standard of care) treatment planned with immunotherapy Possible Beacon plan entitled OP NIVOLUMAB IPILIMUMAB -\\> NIVOLUMAB Q4 WEEK MAINTENANCE MELANOMA 4 cycles will be given prior to surgery (=12 weeks)\n\n    * BASAL CELL CARCINOMA\n  * Signed informed consent\n  * Pathology report confirming basal cell carcinoma with subtype at the time of screening\n  * Resectable tumor of any stage, or unresectable tumor that could be amenable to surgery if there is a good response.\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * SOC treatment planned with possible Beacon plan entitled OP SONIDEGIB BASAL CELL CARCINOMA 3 months will be given prior to surgery (= 12 weeks) (Vismodegib may be substituted if current national shortage of sonidegib persists)\n\n    * RARE CUTANEOUS CANCERS\n  * Signed informed consent\n  * Pathology report confirming squamous cell carcinoma at the time of screening\n  * Stage II, III, or IV resectable or (TNM pathologic staging AJCC UICC 8th edition) or unresectable cancers amenable to surgery if a response is elicited with neoadjuvant therapy\n  * ≥ 18 years of age\n  * Genomics of the cancer attempted\n  * Description of planned surgical resection by surgeon\n  * Planned SOC treatment with possible Beacon plan entitled OP WEEKLY CARBOPLATIN PACLITAXEL + PEMBROLIZUMAB Q3 WEEKS HEAD AND NECK\n\n    * 4 cycles will be given prior to surgery (= 12 weeks)\n\nExclusion Criteria:\n\n* \\* MERKEL CELL CARCINOMA\n\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of MCC within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breast feeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * MUCOSAL MELANOMA\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * BASAL CELL CARCINOMA\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this basal cell carcinoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.\n\n    * RARE CUTANEOUS CANCERS\n  * Metastatic disease not amenable to complete resection\n  * Prior immunotherapy, chemotherapy, or radiation therapy for treatment of this mucosal melanoma within the past year\n  * Any clinically significant medical condition, which in the judgment of the attending physician would contraindicate immunotherapy\n  * Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of SOC treatment.",{"count":510,"type":21},"This study evaluates the time spent on obtaining insurance approval and drugs, means of insurance coverage, out-of-pocket costs for patients, and the surgical outcomes after neoadjuvant treatment is completed in skin cancer patients receiving \"off label\" and \"on label\" neoadjuvant treatment. \"Neoadjuvant therapy\" means cancer treatment given before surgery. However, in many instances, neoadjuvant therapy is used as an \"off-label\" approach for several types of skin cancers. \"Off-label\" means that the FDA has not yet approved its use for that type of cancer. Therefore, insurance approval of these \"off-label\" treatments could be delayed compared to label use, and \"off-label\" treatments may require several weeks of pre-authorization. There is evidence that the delayed start of cancer treatment can lead to poorer outcomes.",[530,531,532,533,534,535,536,537],"Clinical Stage II Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage III Cutaneous Merkel Cell Carcinoma AJCC v8","Clinical Stage IV Cutaneous Merkel Cell Carcinoma AJCC v8","Locally Advanced Basal Cell Carcinoma","Locally Advanced Malignant Skin Neoplasm","Locally Advanced Merkel Cell Carcinoma","Locally Advanced Mucosal Melanoma","Locally Advanced Squamous Cell Carcinoma","2026-06-22",{"date":540,"type":32},"2026-06-25",{"date":542,"type":32},"2026-02-04",{"date":70,"type":21},{"name":38,"class":39},{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":53,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":188,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":564,"locationsCount":72},"100609700","phase-1-neoadjuvant-complete-response-customized-treatment-approach-for-definitive-management-of-breast-cancer-100609700","NCT07217990","Neoadjuvant Complete Response Customized Treatment Approach for Definitive Management of Breast Cancer","NoCUT-BC","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18 years or older\n4. Early-stage breast cancer diagnosis (cT1-3 N0 or cT1-2 N1) and a Human Epidermal Receptor 2 (HER2)-positive or triple negative breast cancer (TNBC) tumor molecular subtype\n5. Planning to receive neoadjuvant chemotherapy (NAC) and radiation therapy (RT)\n\nExclusion Criteria:\n\n1. Pregnancy or lactation\n2. Inmate or prisoner\n3. Treatment with an investigational drug or other intervention throughout their breast cancer treatment\n4. Patients with skin involvement and\u002For distant metastases",{"count":553,"type":21},84,[227,107],"This study will evaluate the efficacy and non-inferiority of a non-surgical approach for the treatment of patients with locally advanced breast cancer.",[374,557,558],"HER2-positive Breast Cancer","Triple Negative Breast Cancer","2026-06-20",{"date":494,"type":32},{"date":562,"type":21},"2026-09-15",{"date":70,"type":21},{"name":38,"class":39},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":53,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":581,"completionDateStruct":582,"leadSponsor":583,"locationsCount":72},"100609588","virtual-reality-viewing-of-unaltered-streetscape-versus-digitally-manipulated-opposite-streetscape-to-assess-psychosocial-response-in-participants-100609588","NCT07216534","Virtual Reality Viewing of Unaltered Streetscape Versus Digitally Manipulated Opposite Streetscape to Assess Psychosocial Response in Participants","Piloting a Virtual Reality-Based, Randomized Controlled Trial of Psychosocial Responses to Neighborhood Physical Disorder","Inclusion Criteria:\n\n* Adults 18+\n* Must currently live (4+ night\u002Fweek) at the residence being studied. Only one resident per household will be selected\n* Must understand and be able to read English\n* Must agree to have residence photographed\n* Must be able to wear a VR head mounted display\n* Must live in neighborhood that has been selected for study\n* Must be willing and able to attend an approximately 2 hour in-person visit on Ohio State University (OSU) campus\n\nExclusion Criteria:\n\n* Pregnant women\n* Visual or mobility impairment\n* Cannot have epilepsy or other condition that would inhibit them from being able to use a VR headset",{"count":573,"type":21},32,[125],"This clinical trial compares virtual reality viewing of an unaltered streetscape versus a digitally manipulated opposite streetscape to assess the psychosocial response in participants. Visible measures of neighborhood factors might be associated with health outcomes and risk factors of those outcomes. Short-term exposure to virtual reality environments representing very high or very low levels of neighborhood physical disorder - presence or absence of garbage\u002Flitter, presence or absence of graffiti, presence or absence of an abandoned building, presence or absence of large dumpsters, poor or very well-kept building conditions, poor or very well-kept yard conditions, poor or very well-kept road verge conditions may be a safe and effective way to assess psychosocial response in participants.",[577,210,578],"Hematopoietic and Lymphatic System Neoplasm","Psychiatric Disorder","2026-06-17",{"date":538,"type":32},{"date":156,"type":21},{"date":242,"type":21},{"name":38,"class":39},""]