[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intervention-study\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intervention-study":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100611796","phase-3-topical-cannabidiol-lotion-for-pruritus-relief-in-scleroderma-100611796",false,"NCT07245238","Topical Cannabidiol Lotion for Pruritus Relief in Scleroderma","Efficacy of Topical Cannabidiol Lotion for Pruritus Relief, Hydrating, Sleep Quality, Quality of Life Improvement in Systemic Sclerosis: a Randomized Double Blinded Controlled Crossover Trial","cannabidiol","Inclusion Criteria:\n\n1. SSc patients aged between 18 and 70 years\n2. Diagnosed according to ACR\u002FEULAR 2013 classification criteria\n3. Having chronic pruritus\n4. Must not receive steroid equivalent to prednisolone dose more than 10 mg\u002Fd\n5. Must receive a stable dose of steroid, immunosuppressant and\u002For vitamin or its supplement within 2 weeks before enrollment\n6. Must stop moisturizer treatment at least 1 week prior to randomization\n7. Must stop anxiolytics, hypnotics or sleeping pills at least 2 weeks before enrollment\n8. Understand and able to read and write Thai language\n\nExclusion Criteria:\n\n1. Overlap with other connective tissue diseases\n2. Pregnancy or lactation\n3. Bedridden and confined to no self-care\n4. Evidence of active malignant disease\n5. Present of uncontrolled or severe medical problems including diabetes mellitus, asthma, angina, cardiovascular, thyroid, hepatobiliary included cholestasis, or renal diseases (Cr\\>1.4 mg\u002Fdl)\n6. Present of active infection that needs systemic antibiotic\n7. Previous allergy to urea cream, cannabinoid or its derivatives\n8. Concomitant illegal drug used (amphetamine or its derivative, cocaine)\n9. On-going anxiolytics, hypnotics or sleeping pills used\n10. In a period that needs immunosuppressant dose adjustment\n11. Having history of schizophrenia, concurrent active mood disorder, or anxiety disorders\n12. Having dermatologic diseases causing pruritus such as atopic dermatitis, contact dermatitis, psoriasis, folliculitis, urticaria, lichen planus, bullous pemphigoid, dermatophytosis, pediculosis, scabies, cutaneous T cell lymphoma, sunburn, drug allergy or skin eruption\n13. Having systemic diseases causing of pruritus other than SSc such as neurologic disease, polycythemia vera","ALL","18 Years","70 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Itching is one of the common symptoms found in patients with scleroderma, with a prevalence of about 42-62%, and it often occurs in the early stages of the disease. The mechanisms of itching are still unclear, and current treatments have not yet shown any clear efficacy in alleviating itching caused by scleroderma. Hemp extract has previously been used to treat itching in chronic skin diseases. Besides its antipruritic (anti-itch) effect, hemp extract also possesses anti-inflammatory properties, increases skin moisture, and helps repair the skin, all without psychoactive effects.\n\nStudies have investigated the benefits of hemp extract in the form of a topical cream with concentrations ranging from 1-5% for the treatment of various skin diseases such as psoriasis, eczema, and the management of fingertip ulcers in scleroderma patients. The results showed that a 1% hemp extract cream relieved itching in eczema and at the same concentration also helped heal fingertip ulcers in scleroderma patients. However, to date, there has been no clear study on the effectiveness of hemp extract in cream or lotion form for treating itching in scleroderma patients. Additionally, there is currently no standard guideline for the management of itching in scleroderma. Generally, 10% urea cream is commonly used to increase skin moisture and alleviate itching, but there has been no prior study on its efficacy specifically for itch relief.\n\nTherefore, this study aims to evaluate the efficacy of a 1% hemp extract combined with 10% urea in lotion form compared to a lotion containing only 10% urea (without hemp extract) in relieving itching, increasing skin moisture, and reducing sleep disturbances caused by itching in scleroderma patients, as well as assessing any potential side effects.",[28,29,30],"Mediciine","Systemic Sclerosis (SSc)","Intervention Study",[32,33,34,35,36,37,38,39,40],"systemic sclerosis","Cannabinoid","Emollients","Crossover study design","Randomized controlled trial","Sleep quality","Pruritus","\\Cannabidiol","Cannabidiol","RECRUITING","2025-11-20",{"date":44,"type":45},"2025-11-24","ACTUAL",{"date":47,"type":45},"2025-11-05",{"date":49,"type":22},"2028-12",{"name":51,"class":52},"Khon Kaen University","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100588519","a-sleep-hygiene-intervention-to-improve-sleep-health-in-urban-latino-middle-school-children-100588519","NCT06942455","A Sleep Hygiene Intervention to Improve Sleep Health in Urban, Latino Middle School Children","SIESTA","Inclusion Criteria:\n\n* children must be middle schoolers between 11-13 years old, live and go to school in one of the targeted school districts and sleep no more than 9 hours on an average night\n\nExclusion Criteria:\n\n* Children are not eligible to take part in the study if they have a medical, psychiatric, or developmental condition and\u002For are taking medicine for any condition that might affect their ability to and comfort with taking part in the study.",true,"11 Years","13 Years",{"count":65,"type":22},300,[67],"NA","The main goal of this study is to evaluate the \"SIESTA\" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health.\n\nThe main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants?\n\nParticipants randomized to the SIESTA intervention will:\n\n1. Attend 4 remotely administered group sleep hygiene education sessions\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nParticipants randomized to the Child Health Control condition will:\n\n1. Attend 4 remotely administered group sessions covering general health topics\n2. Complete along with a parent\u002Fguardian, two individualized sessions administered by a SIESTA intervention facilitator\n3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention.\n4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality.\n\nA secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents\u002Fguardians, as well as school staff and by looking at rates of participation in the program.",[70,71,30,72],"Sleep","Sleep Quality","Ethnic Minority",[74,75,76,77],"pediatric sleep intervention","sleep hygiene intervention","intervention determinants","sleep outcomes","2025-07-22",{"date":80,"type":45},"2025-07-25",{"date":82,"type":45},"2025-06-25",{"date":84,"type":22},"2029-03-31",{"name":86,"class":52},"Rhode Island Hospital",2,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":61,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":53},"100569172","preventt2-together-examining-the-efficacy-of-couple-based-lifestyle-intervention-to-prevent-type-2-diabetes-100569172","NCT06690788","PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes","PT2T","Inclusion Criteria:\n\n1. \"Target partner\" is eligible for the National DPP per CDC eligibility requirements:\n\n   * BMI ≥ 25 kg\u002Fm² (≥ 23 kg\u002Fm² if Asian American), and\n   * Do not have a diagnosis of type 1 or type 2 diabetes, and\n   * Not currently pregnant, and\n   * High risk for type 2 diabetes based on: (i) CDC Prediabetes Risk Test score ≥ 5, (ii) clinically diagnosed Gestational Diabetes during a previous pregnancy (for women), or (iii) a blood test result indicative of prediabetes in the past year (i.e., fasting blood glucose 100-125 mg\u002Fdl; plasma glucose 140-199 mg\u002Fdl measured 2 hours after a 75 g glucose load; or HbA1c 5.7%-6.4%).\n2. The couple has lived together for 1+ years.\n3. Both partners are willing to participate in the research.\n4. Both partners are at least 18 years old.\n5. Both partners are fluent in English.\n\nEXCLUSION CRITERIA:\n\n1. \"Supporting partner\" has a diagnosis of Type 2 Diabetes.\n2. Either partner:\n\n   * Has a diagnosis of another chronic disease (unless no major events\u002Fchanges for 3+ months), or\n   * Is currently on medication or engaged in lifestyle intervention for prediabetes or obesity, or\n   * Has previously participated in the National DPP, or\n   * Reports discomfort participating in a lifestyle program with their partner, or\n   * Reports a low level of relationship commitment (i.e., \"4\" or lower on a scale from 1 (do not agree at all) to 7 (agree completely) on the item \"I want this relationship to stay strong no matter what rough times we encounter.\"; Owen et al., 2011).",{"count":96,"type":22},324,[67],"Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both",[100,101,30,102,103,104],"Prediabetic State","Life Style","Social Support","Physical Activity","Obesity",[106,107,102,108],"Lifestyle Intervention","Prevention","Couple Relationships","2025-05-28",{"date":111,"type":45},"2025-05-30",{"date":113,"type":45},"2025-03-06",{"date":115,"type":22},"2028-11",{"name":117,"class":52},"University of Utah"]