[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pontificia Universidade Católica do Rio Grande do Sul\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":109},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100439112","phase-1-autogenous-mesenchymal-stem-cell-culture-derived-signalling-molecules-as-enhancers-of-bone-formation-in-bone-grafting-100439112",false,"NCT04998058","Autogenous Mesenchymal Stem Cell Culture-Derived Signalling Molecules as Enhancers of Bone Formation in Bone Grafting","Inclusion Criteria:\n\n* patients \\>35 years-old.\n* presenting highly atrophic fully edentulous maxilla (residual bone height \\\u003C5 mm).\n* In need of bilateral sinus floor augmentation aiming full mouth implant-supported rehabilitation.\n* having teeth extraction at least 8 weeks prior to bone augmentation.\n\nExclusion Criteria:\n\n* smokers, illicit drug users and alcohol daily consumers.\n* patients with metabolic and\u002For systemic diseases leading to impaired healing (e.g. decompensated diabetes, leukocyte or coagulation disorders, immunosuppression).\n* history of radiotherapy in the head or neck region.\n* bisphosphonate-based therapy recipients.\n* intolerant to general\u002Flocal anesthesia.",true,"ALL","35 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study aims to evaluate bone formation in grafts in terms of its quality (density), quantity (volume) and maturation obtained with the application of a tissue-engineered bone grafting compound containing concentrated autogenous cell-culture medium (CM) and a synthetic bone substitute. The present study was designed as an experimental prospective split-mouth randomized controlled clinical trial. After protocol approval by the Research Ethics Committee, a total of 20 consecutive participants in need of maxillary reconstruction aiming implant-supported oral rehabilitation will be invited to join the study. To collect autogenous adipose tissue-derived mesenchymal stem cells (hASCs), an outpatient lipoplasty procedure at the abdominal area of each patient will be performed. To isolate and expand hASCs from the lipoaspirate, specific cell culture protocols will be followed, resulting in cultured viable cells and their conditioned medium (CM). Cells and CM will be then separated by a sequence of filters and centrifugation, and isolated CM will be frozen. ELISA will analyze the presence of chemokines and their concentration in CM before grafting. Following pre-op surgical planning, both maxillary sinuses of each patient will be grafted internally applying a lateral window to each sinus. The bony floor of the test maxillary sinus will be augmented with synthetic bone substitute (BoneCeramic™ 1-2 mm) mixed with 10 to 15 ml of CM (test). The control site will receive bone substitute with saline. Lateral windows in both sinuses will be then closed with a collagen membrane (Bio-Gide™). After 6 months, first-stage implant surgery will be performed placing 6 implants in each patient. Registration of implant stability by manual torque wrench will be performed. Also, bone biopsies from each drilled implant site will be collected for histology, histomorphometry and immunohistochemistry (RT-PCR). Tomographic evaluation of the bone formation will include cone beam computed tomographies (CBCTs) at pre-operative \\[Baseline\\], 90 \\[T1\\] and 180 \\[T2 = implant placement\\] days for bone 3D image analysis.",[27,28,29,30,31],"Bone Loss, Osteoclastic","Bone Loss, Alveolar","Alveolar Bone Loss","Alveolar Bone Atrophy","Grafting Bone",[33,34,35,36,37,38,39],"bone","bone formation","bone graft","tissue engineering","stem cell","exosome","cell-free therapy","NOT_YET_RECRUITING","2025-06-02",{"date":43,"type":44},"2025-06-05","ACTUAL",{"date":46,"type":20},"2025-12-15",{"date":48,"type":20},"2026-12-30",{"name":50,"class":51},"Pontificia Universidade Católica do Rio Grande do Sul","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100590672","efficacy-of-spinal-orthoses-on-mobility-in-older-adults-with-hyperkyphosis-100590672","NCT06970470","Efficacy of Spinal Orthoses on Mobility in Older Adults With Hyperkyphosis","Efficacy of Spinal Orthoses in Functional Mobility of Older Adults With Hyperkyphosis: Study Protocol for a Randomized Clinical Trial","Inclusion Criteria:\n\n* Aged 60 years or older\n* Clinical diagnosis of hyperkyphosis\n* Ability to walk without assistive devices\n\nExclusion Criteria:\n\n* Cognitive impairment\n* Inability to complete the proposed assessments\n* Non-compliance with orthosis use during the intervention period","60 Years",{"count":62,"type":20},75,[64],"NA","This study investigates whether wearing specific back braces (spinal orthoses) can improve movement and physical function in older adults (60 years and older) with hyperkyphosis, a forward curvature of the upper spine. By testing two types of braces, the study seeks to find effective ways to manage hyperkyphosis and enhance mobility, independence, and quality of life in this population.\n\nStudy Purpose\n\nThe purpose is to evaluate the impact of two types of thoracic spinal orthoses on functional mobility, which includes walking, muscle function, and overall physical activity. This information will help healthcare providers better understand how braces can be used to manage hyperkyphosis and improve daily functioning for older adults.\n\nWho Can Participate?\n\nThe study will include adults aged 60 or older who have been diagnosed with hyperkyphosis. Eligible participants will be randomly assigned to one of three groups:\n\n1. Group 1: Participants will use the Triple-Adjustable Posture Corrector (TAPC), a brace designed to improve posture and reduce kyphosis.\n2. Group 2: Participants will use the Generation Dynamic Osteoporosis Brace (G-DOB), another type of spinal brace targeting posture and mobility.\n3. Control Group: Participants will not wear any brace.\n\nHow the Study Works\n\nThe study will run for 16 weeks. Participants in the brace groups will wear their assigned braces throughout the day, except during specific activities like bathing, sleeping, and swimming. No other changes to their daily routines will be required.\n\nAt the start and end of the study, participants will undergo assessments to measure their physical function and mobility. These assessments will include:\n\n* Gait analysis: Evaluates walking patterns using advanced 3D motion technology.\n* Muscle strength and joint function testing: Measures how well muscles and joints are working using isokinetic dynamometry.\n* Muscle activity recording: Tracks how muscles respond during movement using surface electromyography (EMG).\n* Physical activity monitoring: Captures activity levels using accelerometers, which are small devices that track movement.\n\nWhy Is This Study Important?\n\nHyperkyphosis can lead to challenges in daily life, such as difficulty walking, decreased balance, pain, and a higher risk of falls. While physical therapy and exercise are common treatments, many older adults need additional support to manage the condition. Spinal orthoses may offer a practical, non-invasive option to improve posture, reduce symptoms, and increase physical activity.\n\nBy comparing the effects of these two braces, the study aims to:\n\n1. Determine whether these orthoses improve functional mobility, such as walking and muscle performance.\n2. Provide evidence to guide healthcare professionals in using braces to treat hyperkyphosis.\n3. Develop a standardized approach for incorporating orthoses into the care of older adults with this condition.\n\nBenefits for Participants\n\nWhile the study focuses on research, participants may also experience direct benefits, such as:\n\n* Improved posture and comfort while moving.\n* Increased awareness of their physical health and function.\n* Access to state-of-the-art assessments and expert support throughout the study.\n\nHow Will Results Be Used?\n\nThe findings will inform healthcare providers about the potential benefits of using spinal braces for older adults with hyperkyphosis. If successful, this research could lead to:\n\n* Better treatment plans for patients.\n* Increased availability of braces tailored for older adults.\n* Improved quality of life for people living with hyperkyphosis.\n\nKey Takeaways for Patients and Families\n\n* Hyperkyphosis is a manageable condition, and this study explores a promising new way to support mobility and independence.\n* Participation involves wearing a brace during regular daily activities and attending two comprehensive evaluations.\n* The study is safe, non-invasive, and designed to minimize disruptions to daily life.\n\nThis research offers an exciting opportunity to improve care for older adults with hyperkyphosis. By understanding how braces affect movement and strength, healthcare providers can develop better tools and strategies to support aging populations. Families and caregivers can also benefit from knowing there are new, evidence-based options to help their loved ones stay active and independent.",[67],"Hyperkyphosis",[69,70,71],"Older Adults","Spinal Orthoses","Biomechanics","2025-05-19",{"date":74,"type":44},"2025-05-22",{"date":76,"type":20},"2025-06",{"date":78,"type":20},"2026-09",{"name":50,"class":51},2,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":15,"sex":16,"minAge":60,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100536931","effect-of-multicomponent-exercises-vivifrail-in-older-adults-100536931","NCT06271239","Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults","Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults","Inclusion Criteria:\n\n* Eligible participants are older adults of both genders, aged at least 60 years.\n* Participants must be actively participating in regular meetings of elderly groups within the social assistance program in Porto Alegre.\n* Participants should not have severe visual, hearing, or cognitive impairments that could impede the safe completion of proposed assessments or exercises\n\nExclusion Criteria:\n\n* Participants with scheduled surgeries or procedures within the next eight months hindering engagement in the exercise program are excluded.\n* Those unable to sit unsupported for at least 10 minutes during the functional assessment or demonstrating an inability to respond to verbal commands in the cognitive assessment are excluded.\n* Exclusion criteria specific to the VIVIFRAIL® exercise protocol include:\n* Recent acute myocardial infarction or unstable angina within 6 months\n* History of uncontrolled arrhythmias\n* Dissecting aortic aneurysm\n* Severe aortic stenosis\n* Acute endocarditis\u002Fpericarditis\n* Uncontrolled hypertension\n* Acute thromboembolic disease\n* Severe acute heart failure\n* Severe acute respiratory failure\n* Uncontrolled orthostatic hypotension\n* Acute decompensation of diabetes mellitus or uncontrolled hypoglycemia\n* Recent fracture within the last month\n* Any other circumstances deemed prohibitive or risky for engaging in physical activity are also grounds for exclusion.",{"count":89,"type":20},50,[64],"This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.\n\nIn the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.\n\nConversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.",[93,94,95],"Frailty","Aging","Physical Disability",[94,97,93,98],"Public Health","Exercise","RECRUITING","2024-06-05",{"date":102,"type":44},"2024-06-06",{"date":104,"type":44},"2024-05-28",{"date":106,"type":20},"2025-05-30",{"name":50,"class":51},4,""]