[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Rosalind Franklin University of Medicine and Science\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":89},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100471208","impact-of-removable-cast-walker-design-on-usability-for-patients-with-diabetic-foot-ulcers-100471208",false,"NCT05415878","Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers","Improving Diabetic Foot Ulcer Offloading: A Pilot Study on the Impact of Removable Cast Walker Design Factors on Usability","Inclusion Criteria:\n\n* presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that is being treated on an outpatient basis with a University of Texas wound classification of 1A-C or 2 A-C;\n* self-reported ability to walk for at least two continuous minutes at a self-selected speed\n* confirmation of the presence of diabetic peripheral neuropathy as identified by failure to detect a 10 gram Semmes Weinstein Monofilament on either foot at one of four sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) OR a vibration perception threshold value of 25 or more at either hallux.\n\nExclusion Criteria:\n\n* lower extremity amputation more proximal than transmetatarsal on either limb\n* chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or eGFR\\\u003C30 within last 60 days)\n* active Charcot neuroarthropathy\n* severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalis pedis arteries, and an ankle brachial index\\\u003C0.7)\n* gait\u002Fbalance disturbance not attributable to diabetes (e.g. neuromuscular disease or cerebrovascular vascular accident)\n* current or previous (within past year) use of an ankle-high RCW or of a contralateral lift to offset an RCW-induced LLD","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. While RCWs are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. This is a serious concern given that low adherence predicts poor DFU healing. This study will provide pilot\u002Ffeasibility data to inform a larger clinical trial to evaluate the impact of existing RCW designs on adherence and DFU healing. We will also quantify the effect of RCW form on biomechanical and self-reported measures related to usability. Our working hypothesis is that healing outcomes with a given RCW will be predicted by biomechanical and self-reported measures of RCW usability, with the predictive relationship partly explained by the effect of these measures on adherence.",[26,27],"Diabetes Mellitus","Foot Ulcer","RECRUITING","2026-08-17",{"date":31,"type":32},"2026-08-19","ACTUAL",{"date":34,"type":32},"2023-08-02",{"date":36,"type":20},"2027-05-30",{"name":38,"class":39},"Rosalind Franklin University of Medicine and Science","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":40},"100533947","menthol-inflammation-and-nicotine-transition-study-100533947","NCT06232447","Menthol, Inflammation, and Nicotine Transition Study","Effect of Menthol to Non-Menthol Cigarette Switching on Subclinical Inflammatory Biomarkers of Cardiovascular Health: Simulating a Menthol Cigarette Ban","MINT","Inclusion criteria\n\n* Men and women between 21-85 years old\n* Currently uses menthol cigarettes\n* Daily smoking rate of ≥5 cigarettes\u002Fday for ≥1 year\n* Currently own and regularly use an iOS\u002FAndroid smartphone device able to download the LifeData application\n* Able to read and communicate fluently in English\n\nExclusion criteria\n\n* Currently pregnant or breastfeeding\n* Actively trying to quit smoking\n* Current heavy alcohol use\n* Frequent use of non-menthol cigarettes, other smoking products, or illicit substances\n* History of severe medical\u002Fpsychiatric condition or treatment",true,"21 Years","85 Years",{"count":53,"type":20},68,[23],"This study will focus on examining the potential impact of menthol flavoring in cigarettes on biomarkers of systemic inflammation as a subclinical indicator of cardiovascular disease risk.",[57,58],"Cigarette Smoking","Inflammatory Response","2026-04-14",{"date":61,"type":32},"2026-04-16",{"date":63,"type":32},"2024-03-26",{"date":65,"type":20},"2027-06",{"name":38,"class":39},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":40},"100541513","race-based-stress-and-cognitive-training-for-mci-100541513","NCT06330844","Race-Based Stress and Cognitive Training for MCI","Race Based Stress and Empowerment Focused Compensatory Cognitive Training for Mild Cognitive Impairment","Inclusion Criteria:\n\n* The study will be conducted in-person, so they must be able to travel to Rosalind Franklin University.\n* The study will initially be limited to participants who self-identify as Black\u002FAfrican American, or who self-identify with other racial\u002Fethnic groups in addition to self-identifying as Black\u002FAfrican-American; however, may be expanded to include participants that identify as Hispanic\u002FLatine.\n\nExclusion Criteria:\n\n* Participants are ineligible to participate in this study if they are not at least 65 years of age and are not experiencing at least mild cognitive impairment or self-reported cognitive difficulties.\n* Participants will also be excluded if they have a diagnosis of dementia (i.e., major neurocognitive disorder), intellectual disability, mild head injury (i.e., concussion) within the last six months, and\u002For a history of moderate to severe traumatic brain injury.\n* Diagnosis of dementia may be from self-report or other medical records, or for participants to fail screening cognitive assessments (i.e., the RBANS) that would suggest they may be at the level of dementia (i.e., major neurocognitive disorder) as ultimately determined by study PI with objective scores less then 2 standard deviations below the mean on the RBANS.","65 Years",{"count":76,"type":20},9,[23],"This a two phase project that aims to pilot a new adaptation (Phase 1) of Motivationally Enhanced Compensatory Cognitive Training for Mild Cognitive Impairment (ME-CCT; an originally VA-based cognitive rehabilitation manualized intervention for older adults with MCI, with a focus on the impact of stress on cognitive functioning; that integrates components from the Race Based Stress and Empowerment (RBSE) group for an increased focus on race-based stress and discrimination for racial minority older adults (i.e., RBSEF-CCT-MCI). In a pilot open trial, 75-150 participants will receive group-based intervention for 8 weeks, with 8-10 participants per group.\n\nFollowing the pilot study, the investigators will complete a randomized controlled trial (RCT) (Phase 2) to compare the efficacy of the RBSEF-CCT-MCI with the ME-CCT. In the RCT, 75-150 participants will be randomized into either 1) The active control group, who will complete the original, ME-CCT training program, or 2) The experimental group, who will complete the newly developed RBSE-CCT-MCI. Both research groups will complete the interventions for 8 weeks, with 8-10 participants per group.\n\nHypothesis: Participation in this newly developed\u002Fupdated intervention (i.e., RBSEF-CCT-MCI) will result in improvements in both (a) subjective and (b) objective cognitive functioning, and (c) self-reported mental health symptoms.",[80],"Mild Cognitive Impairment","2025-07-21",{"date":83,"type":32},"2025-07-24",{"date":85,"type":32},"2025-03-01",{"date":87,"type":20},"2028-03-15",{"name":38,"class":39},""]