[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wake Forest University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":191},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,75,106,132,162],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100205612","phase-1-muscle-fiber-fragment-treatment-for-urinary-incontinence-100205612",false,"NCT01953263","Muscle Fiber Fragment Treatment for Urinary Incontinence","A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence","Inclusion Criteria:\n\n* Adult female patients who are not pregnant or lactating\u002Fbreast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator\n* Patients between the ages of 18 and 75 years\n* Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and\u002For congenital conditions.\n* Patients with cystometric capacity of bladder \\> 100 ml\n* Patients with normal renal function\n* Patients with a history of primary incontinence\n\nExclusion Criteria:\n\n* Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder\n* Patients with an active urinary tract infection as evidenced by positive urine culture\n* Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas\n* Patients requiring concomitant use of or treatment with immunosuppressive agents\n* Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study\n* Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy)\n* Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study\n* Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study\n* Patients with urinary incontinence other than the categories being investigated\n* Patients with significant (\\>grade 2) pelvic organ prolapse\n* Patients with vaginal prolapse beyond introitus\n* Patients with neurological disorders\n* Patients with abnormal bladder capacity (i.e., less than 100 cc)\n* Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment","FEMALE","18 Years","75 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck\u002Furethra).",[28],"Urinary Incontinence",[30],"urinary incontinence, muscle fibers","RECRUITING","2026-04-22",{"date":34,"type":35},"2026-04-23","ACTUAL",{"date":37,"type":4},"2016-01",{"date":39,"type":21},"2028-12",{"name":41,"class":42},"Wake Forest University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100622307","effects-of-muscle-cooling-on-motor-unit-firing-of-the-quadriceps-100622307","NCT07381920","Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps","Effects of Muscle Cooling on Motor Unit Firing of the Quadriceps: A Pilot Feasibility Study","CRYO","Inclusion Criteria:\n\n* Men and women between the ages of 18 and 35 years\n* Healthy adults, defined as absence of significant acute\u002Fchronic medical condition, injury, and\u002For illness that may compromise subject safety, limit the ability of the participant to complete the study, and\u002For compromise the objectives of the study as determined by the Principal Investigator.\n\nExclusion Criteria:\n\n* Current diagnosis or history of:\n\n  * major metabolic disease (e.g., type I and type II diabetes),\n  * neuromuscular disease (e.g., cervical spondylotic radiculomyelopathy, lumbar spondylosis, amyotrophic lateral sclerosis, Guillain-Barré syndrome, and acquired demyelinating polyneuropathies),\n  * cardiovascular disease (e.g., stage II hypertension, heart failure, myocardial infarction\u002Fischemia, peripheral vascular disease, Raynaud's phenomenon, or other conditions associated with impaired peripheral circulation),\n  * significant myocardial or pericardial diseases (e.g. amyloidosis, constriction),\n  * moderate or severe valvular disease,\n  * pulmonary\u002Frespiratory disease (e.g., asthma, chronic bronchitis, emphysema, chronic obstructive pulmonary disease),\n  * cancer,\n  * renal disease,\n  * liver disease,\n  * or anemia.\n* Current or recent musculoskeletal injury (e.g. fracture, sprain, dislocation) or any physical disability that precludes safe and adequate testing.\n* Pregnancy or breastfeeding.\n* Thigh circumference greater than 23 inches\n* Mid-thigh skinfold thickness greater 40 mm",true,"ALL","35 Years",{"count":56,"type":21},24,[58],"NA","The overall objective of this pilot study is to establish the feasibility and methodological validity of using high-density surface electromyography to characterize motor unit behavior of the quadriceps under thermoneutral and locally cooled conditions, and to generate preliminary data to inform the design of a larger, hypothesis-driven study.",[61],"Healthy",[63,64,65,66],"muscle cooling","motor unit behavior","HDsEMG","Quadriceps","2026-02-23",{"date":69,"type":35},"2026-02-27",{"date":71,"type":35},"2026-01-20",{"date":73,"type":21},"2027-05",{"name":41,"class":42},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":53,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":43},"100564015","phase-2-a-mobile-intervention-to-reduce-pain-and-improve-health-iii-100564015","NCT06623669","A Mobile Intervention to Reduce Pain and Improve Health-III","MORPH-III","Inclusion Criteria:\n\n* Aged 65+ years\n* Body mass index of 30-45 kg\u002Fm2 or \\>45 kg\u002Fm2 with physician's approval\n* No loss or gain of more than 5% body mass in previous 6 months\n* Presence of knee or hip osteoarthritis as ascertained via the Roux questionnaire\n* Independently living\n* Low active (i.e., not participating in regular resistance training and\u002For \\>20 mins\u002Fday of aerobic exercise on more than 2 days\u002Fweek in past 3 months as ascertained via a modified CHAMPS questionnaire)\n* Have no contraindication for safe and optimal participation in exercise based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use of assistive devices)\n* Not currently using a weight loss medication (medications for diabetes management are permitted if weight stable)\n* Approved for participation by medical director\n* Willing to provide informed consent and agree to all study procedures and assessments.\n\nExclusion Criteria:\n\n* Reside in skilled nursing facility, rehab or assisted living environment\n* History of pharmacologic treatment for a psychiatric disorder other than depression\u002Fanxiety within past year\n* Current untreated and\u002For unstable clinical depression or anxiety (Patient Health Questionnaire (PHQ-9) \\>15)\n* Hospitalization for psychiatric event within past year prior to screening\n* History of mild cognitive impairment or dementia\n* Cognitive impairment (\\\u003C32) on Modified Telephone Interview for Cognitive Status survey (TICS-M)\n* Hearing or visual impairment that would preclude use of the videoconferencing software\n* Severe arthritis or other musculoskeletal disorder that is a contraindication for safe walking\n* Presently undergoing treatment for orthopedic fracture\n* Currently using a weight loss medication (medications for diabetes management are permitted if weight stable)\n* Contraindication based on EASY screening (pertaining to chest pain and discomfort during physical activity, dizziness or light headedness, or frequent falls and use of assistive devices) without physician approval\n* Joint replacement or other orthopedic surgery in past 6 months\n* Joint replacement or other orthopedic surgery planned in next 18 months\n* Have a diagnosis of uncontrolled hypertension; current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease; cancer requiring current treatment, except non-melanoma skin cancers; kidney failure requiring dialysis; have a Katz ADL disability; or engage in heavy alcohol use \\>14 drinks\u002Fweek.\n* Current participation in other research study with a prospective intervention\n* Unable\u002Funwilling to commit to study protocol, including random assignment and use of technology tools\n* Unable\u002Funwilling to attend three virtual testing appointments","65 Years",{"count":84,"type":21},200,[25],"The experience of chronic pain powerfully and negatively affects quality of life and functional independence in aging. Unfortunately, while as many as three in four older adults experience chronic pain, few have access to effective non-pharmacological pain management strategies. Participating in regular physical activity, avoiding sustained sitting, and maintaining a healthy weight are important and interrelated lifestyle inputs to chronic pain, and socially rich behavioral interventions informed by contemporary theories of behavior change appear important for engaging in activity and healthy eating in the long term. Our group has demonstrated in a series of Stage I trials that a group-mediated behavioral intervention combining dietary behavior change and a physical activity program focused on moving often throughout the day contributes to meaningful weight loss, and lasting weight maintenance, with pilot data suggesting this may contribute to improved pain, physical function, and health-related quality of life among older adults with chronic pain. As these were NIH Stage I trials, there are several important gaps to be addressed in the present trial: (1) both studies of chronic pain recruited small samples and were 12 weeks in duration, limiting our ability to establish efficacy and the durability of changes to activity, HRQOL, and pain outcomes; (2) participants included anyone with chronic pain, regardless of pain type, a likely contributor to heterogeneous pain intensity and interference findings; and (3) the investigators have yet to examine behavioral maintenance.\n\nThe overarching goal of the proposed Stage II \"mobile intervention to reduce pain and improve health-III (MORPH-III)\" is to establish the efficacy of the intervention for enhancing physical activity via steps (primary), and for reducing pain interference and body weight while enhancing physical function (secondary) among older adults with chronic knee or hip osteoarthritic (OA) pain. The investigators will recruit 200 older adults with knee or hip osteoarthritic pain to engage in a 6-month remotely delivered intervention comprising weekly group or individual intervention meetings plus brief individual goal-setting coaching calls. This will be followed by a 12-month no-contact maintenance period, where participants will attempt to sustain behavioral goals on their own.\n\nThe Specific Aims are:\n\nSpecific Aim 1: To examine the impact of MORPH on ActivPAL-assessed daily steps relative to an enhanced usual care control. Hypotheses: MORPH will significantly increase steps relative to control at month 6.\n\nSpecific Aim 2: To examine the impact of MORPH on pain interference, change in body weight, and physical function relative to the enhanced usual care control. Hypotheses: MORPH will result in significant reductions in pain interference and body weight and improvement in physical function relative to control at month 6.\n\nExploratory Aims: Aim 1: To investigate the impact of the MORPH intervention on steps, weight change, pain interference, and physical function at month 18. Aim 2: If the MORPH intervention results in reduced pain interference at 6 and\u002For 18 months, the investigators will examine the extent to which 6-month change in steps, weight, pain self-efficacy, and catastrophizing mediate change in interference at 6 and\u002For 18 months.",[88,89,90,91],"Chronic Pain","Osteoarthritis","Obesity and Overweight","Inactivity",[93,94,95,96,97],"Digital health","Randomized Trial","Physical Activity","Weight Loss","Aging","2026-02-18",{"date":100,"type":35},"2026-02-20",{"date":102,"type":35},"2025-08-14",{"date":104,"type":21},"2029-08-31",{"name":41,"class":42},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":52,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100511945","the-osteoarthritis-prevention-study-100511945","NCT05946044","The Osteoarthritis Prevention Study","TOPS","Inclusion Criteria:\n\n* Female\n* BMI ≥ 30 kg\u002Fm2\n* An eligible knee will have no OA by xray and MRI\n* No or infrequent knee pain (\\\u003C 15 days\u002Fmonth) in the same knee\n\nExclusion Criteria:\n\n* symptomatic or severe coronary artery disease\n* unable to walk without a device\n* blindness\n* type 1 diabetes\n* active treatment for cancer\n* during the past 12 months knee fracture, anterior cruciate ligament (ACL), medial collateral ligament (MCL), or meniscus injury with or without surgical repair\n* knee injection during the past 6 months\n* bilateral knee OA by x-ray Kellgren-Lawrence (KL) ≥ 2\n* bilateral knee OA by MRI\n* bilateral symptomatic knee OA (frequent bilateral knee pain \\> 15 days per month)\n* BMI\\\u003C 30.0 kg\u002Fm2\n* male sex\n* claustrophobia\n* contraindication to MRI including body weight \\> 300 lbs or knee coil does not fit\n* unwillingness or inability to change eating and physical activity habits due to environment\n* cannot speak and read English\n* planning to leave area \\> 2 months during the 48-month intervention period","50 Years",{"count":115,"type":21},1230,[58],"The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.",[119],"Osteoarthritis, Knee",[121,122],"Obesity","Knee Pain","2025-07-18",{"date":125,"type":35},"2025-07-23",{"date":127,"type":35},"2024-03-21",{"date":129,"type":21},"2029-07-31",{"name":41,"class":42},4,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":52,"sex":53,"minAge":140,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":151,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":43},"100420552","the-vespa-pilot-study-100420552","NCT04756245","The VESPA Pilot Study","The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study","VESPA","Inclusion Criteria:\n\n* Age of 45-80 years\n* Body mass index between 30-45 kg\u002Fm2\n* Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week)\n* Have access to home Wi-Fi\n* Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls\n* Have a clear \"VR space\" (7'x7' object-free space)\n* Have an \"Activity buddy\" (spouse, child, caregiver, etc.)\n* Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater\n* Consent from a physician for study participation\n* Proficient in the English language\n* Willingness to create or use existing personal Facebook account for virtual reality activities.\n\nExclusion Criteria:\n\n* Current involvement in other physical activity research studies\n* Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness)\n* Dependence on a cane or walker\n* More than 1 fall in the past year\n* Contraindication to exercise\n* Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months\n* History of or diagnosis of photosensitive epilepsy\n* Score of \"severe\" on any question in the Virtual Reality Sickness Questionnaire;\n* Unwillingness to use a head-mounted virtual reality system\n* Current severe or untreated depression","45 Years","80 Years",{"count":143,"type":21},30,[58],"Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change.\n\nA half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are:\n\nSpecific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults.\n\nSpecific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.",[147,148,149,150],"Exercise","Behavior","Loneliness","Social Isolation",[152,153,95],"Telehealth","Virtual Reality","2025-07-14",{"date":156,"type":35},"2025-07-16",{"date":158,"type":35},"2020-12-17",{"date":160,"type":21},"2026-12-30",{"name":41,"class":42},{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":52,"sex":53,"minAge":17,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":179,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":43},"100544961","probiotic-effect-on-dietary-nitrate-to-plasma-nitrite-production--opednpn--100544961","NCT06375694","Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production ( OPEDNPN )","Oral Probiotic Effect on Dietary Nitrate to Plasma Nitrite Production","OPEDNPN","Inclusion Criteria:\n\n* Healthy adult volunteers ages 18-70\n\nExclusion Criteria:\n\n* Individuals with a history of difficult blood draws. More than 2 blood draws in one week; on anti-coagulant or anti-platelet therapy (e.g. aspirin, Coumadin, etc.); known pregnancy; in police custody or a prisoner; common illness within 2 weeks of potential enrollment. The cumulative volume of blood drawn from a healthy adult over the prior eight-week period would exceed 550 ml including the current draw.\n* In addition, individuals uncomfortable spitting into a tube, dry mouth (xerostomia) or dry eyes, Patients suffering from autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or progressive systemic sclerosis, since individuals with these autoimmune inflammatory diseases exhibit persistent xerostomia, individuals with active caries diagnosis or history of periodontitis","70 Years",{"count":172,"type":21},20,[58],"Nitric Oxide (NO) is an important molecule that is produced naturally in the body and that helps maintain healthy blood flow. Low availability of NO contributes to many diseases while administration of NO is therapeutic.\n\nIn addition to being made naturally in the body, NO can be obtained through the diet via the Nitrate-Nitrite-NO cycle. Nitrate, which is abundant in green leafy vegetables and beetroot juice, is partially converted to nitrite by oral bacteria. The nitrate and nitrite are taken up into the blood and nitrite is converted into NO. Remaining nitrate in the blood is taken back up into the mouth by salivary glands and the cycle continues. Emerging studies suggest that the Nitrate-Nitrite-NO cycle may contribute to cardiovascular health. In addition, there have been many studies where dietary nitrate is given to increase NO and treat various conditions.\n\nThe current study rests on the premise that the quality of the oral microbiome plays a major role in the Nitrate-Nitrite-NO cycle and hence cardiovascular health and the efficacy of dietary nitrate interventions. Investigators have begun to identify oral bacterial species that are effective nitrite producers as well as though that are nitrite depleters (those that interfere with nitrite production from nitrate).\n\nIn laboratory experiments, certain bacterial species have been shown to block nitrate to nitrite conversion by other oral bacteria. These nitrite depleting species are found in a commercially available oral probiotic designed to improve oral health. The purpose of this study is to examine if use of the probiotic negatively affects the Nitrate-Nitrite-NO cycle. Nitrate to Nitrite conversion will be assessed by measuring plasma levels of nitrite before and after consumption of nitrate-rich beetroot juice. Dietary nitrate to plasma nitrite conversion will assessed at baseline and after one week of consumption of the probiotic or a placebo (follow-up). The primary hypothesis of this study is that participants that consume the probiotic will have lower nitrate to nitrite conversion at follow-up compared to baseline and that there will be no significant change in nitrate to nitrite conversion between baseline and follow-up for participants who consume the placebo.\n\nWhile this study does not aim to treat any specific disease, it is intended to elucidate a basic physiological function that may be relevant to cardiovascular health and certain NO-based therapeutics.",[176,177,178],"Hypertension","Cardiovascular Diseases","Diabetes",[180,181,182],"Nitric Oxide","Nitrate","Microbiome","2024-07-17",{"date":185,"type":35},"2024-07-19",{"date":187,"type":35},"2024-06-01",{"date":189,"type":21},"2025-05",{"name":41,"class":42},""]