[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of KwaZulu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100619041","feasibility-and-acceptability-of-an-intervention-to-support-people-with-severe-mental-illness-in-south-africa-100619041",false,"NCT07339462","Feasibility and Acceptability of an Intervention to Support People With Severe Mental Illness in South Africa","Feasibility and Acceptability of Critical Time Intervention to Support People With Severe Mental Illness Following Post-acute Hospital Discharge in South Africa","MhINT Recovery","Service user inclusion criteria:\n\n* Adults (aged 18 years and above);\n* Being admitted to the psychiatric ward of a hospital for observation and treatment due to an acute psychiatric event, based on ICD diagnosis on patient charts according to the following criteria:\n\n  * F20-29 including schizophrenia, delusional disorders, schizotypal disorders, acute polymorph psychotic disorders, schizoaffective disorders\n  * F30-39 Mood \\[affective\\] disorders with psychoses\n  * F30.2 Mania with psychotic symptoms\n  * F31.2 Bipolar affective disorder, current episode manic with psychotic symptoms\n  * F31.5 Bipolar affective disorder, current episode severe depression with psychotic symptoms\n  * F32.3 Severe depressive episode with psychotic symptoms\n  * F33.3 Recurrent depressive disorder, current episode severe with psychotic symptoms\n* Determined by the attending psychiatrist to be discharged into community settings following appropriate recovery from the psychiatric event;\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu\n\nService user exclusion criteria:\n\n* Under 18 years of age\n* Are indicated by their chart history to have the following conditions:\n\n  * Active suicidal ideation\n  * Substance abuse or dependence as primary diagnosed psychiatric condition\n  * Personality disorders\n  * Serious cognitive or other sensorial impairment likely to preclude informed consent and reliable assessment\n* Does not reside with a caregiver\n* Does not reside within the geographic boundaries of uMgungundlovu\n\nCaregiver inclusion criteria\n\n* Adults (aged 18 years and above)\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu\n\nCaregiver exclusion criteria\n\n* Adults (aged 18 years and above)\n* Willing and able to participate in the intervention programme\n* Resides with a caregiver (which could be a family member or member of the household).\n* Resides within the geographic boundaries of uMgungundlovu","ALL","18 Years",{"count":20,"type":21},86,"ESTIMATED","INTERVENTIONAL",[24],"NA","Despite commendable progress in developing mental health systems in low-and-middle income countries, critical gaps remain, particularly the development of community-based systems of support for people living with severe mental illness (SMIs). This application will pilot a co-developed health system strengthening intervention programme in a South African district in order to determine its feasibility, appropriateness and limited efficacy in reducing readmission following discharge from acute psychiatric hospitalization. By generating preliminary data on the real-world implementation of a co-developed programme in low-resource contexts in South Africa, this application seeks to build on an existing foundation of research partnerships and local government collaboration to develop a transitional support intervention that could yield significant and tangible impacts on people living with SMIs in low-resource communities.",[27],"Mental Disorders, Severe",[29,30,31,32,33,34,35],"Severe mental illness","Community-based care","Family empowerment","Recovery","Hospital readmission","Deinstitutionalization","Integrated care","RECRUITING","2026-01-13",{"date":39,"type":40},"2026-01-14","ACTUAL",{"date":42,"type":40},"2025-08-01",{"date":44,"type":21},"2026-08-31",{"name":46,"class":47},"University of KwaZulu","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100549089","phase-3-anti-inflammatory-reliever-south-africa-100549089","NCT06429475","Anti-Inflammatory Reliever South Africa","Anti-Inflammatory Reliever Therapy for Asthma Using Inhaled Budesonide\u002FFormoterol As-needed With or Without Maintenance in South African Children: A Pragmatic Open Label Phase 3 Randomised Controlled Trial","AIRSA001","Inclusion Criteria:\n\n* Age for inclusion children and adolescents 6-18 years at the time of consent\n* Known asthmatic on treatment.\n* Newly diagnosed asthma based on investigator review and\u002For medical report.\n* All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks.\n* Ability to perform Peak Expiratory Flow rate and\u002For bronchodilator reversibility testing.\n* Only participants with mild, or moderate asthma , based on medical history\n* At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for ≥3 days and\u002For a hospitalisation\u002Femergency room visit for asthma requiring treatment with systemic corticosteroids.\n* Written consent from the participant or parent\u002Fguardian and assent from study participants where applicable.\n* Participant and\u002For parent\u002Fguardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits\n\nExclusion Criteria:\n\n* Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months.\n* Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months.\n* Cardiac arrythmia.\n* Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension.\n* Uncontrolled diabetes mellitus\n* Patients with Peak Expiratory Flow Rate \\\u003C 50% of predicted , as these would be classified as severe asthmatics.\n* Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).\n* Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy).\n* Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer's medical history.\n* Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator's judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer's medical history.\n* Inability to present for follow-up or leaving the study area within 12 months of enrolment.","6 Years",{"count":59,"type":21},1038,[61],"PHASE3","This is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide\u002Fformoterol 80\u002F4.5 (6-11 years) and 160\u002F4.5 (12-18 years) compared to the standard of care in reducing asthma exacerbations over 52 weeks.\n\nChildren and adolescents with a diagnosis of asthma or newly diagnosed with asthma will be screened for eligibility for enrolment. Those who had an asthma exacerbation in the previous year will be randomised 1:1, to either receive budesonide\u002Fformoterol inhaler for both symptom relief and for chronic anti- inflammatory maintenance therapy or the standard of care which is separate inhalers for symptom relief (short acting bronchodilator salbutamol) and chronic maintenance therapy with inhaled corticosteroids (beclomethasone or budesonide) and\u002For long-acting beta agonists or montelukast as determined by treating physicians. All asthma exacerbations and clinic\u002Fhospital admissions will be recorded for the duration of the 52-week follow-up. Participants will be followed up at 13, 26, 39 and 52 weeks. The 13- and 39-week visit will be telephonic visits to capture the primary end-point i.e. asthma exacerbations. Adverse events and medication changes data will also be collected.\n\nAn independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in asthma and asthma clinical trials. The purpose of the DSMB will be to monitor the study for safety and operational futility with pre-defined stopping criteria. In addition, a Trial Steering Committee (TSC) will also provide overall supervision of the trial and ensure the trial is delivered in accordance with ICH-GCP. The TSC has been established with an independent Chair and include additional independent members including an observer early career researcher. Representatives of the Trial Funder (NIHR) and Sponsor (AHRI) will be invited to all TSC meetings.",[64],"Asthma",[66,67,68,69,70,71],"asthma","budesonide\u002Fformoterol","beclomethasone","budesonide","children","adolescents",{"date":73,"type":40},"2026-01-15",{"date":75,"type":40},"2024-06-06",{"date":77,"type":21},"2028-12-31",{"name":46,"class":47},2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":17,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":4,"studyType":22,"phases":92,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":48},"100555781","evaluation-of-skipping-rope-and-informational-pamphlet-among-adolescents-in-south-africa-100555781","NCT06516549","Evaluation of Skipping Rope and Informational Pamphlet Among Adolescents in South Africa","Impact of Skipping Rope and Informational Pamphlet on Physical Activity Among Adolescents in South Africa","Inclusion Criteria:\n\n* Study participant is between ages 10 and 14 years;\n* Minors (i.e. less than 18 years of age): the parents or guardians provide written informed consent;\n* Minors: the minor participant provides informed assent;\n* Study participant is a resident of the study area and intends to stay in the study area for the duration of the study;\n\nExclusion Criteria:\n\n* Participants with physical disabilities that prevent them from doing physical activity will be excluded;\n* Those participants whose capacity to make meaningful decisions is in question because they are \\"cognitively impaired\" will be excluded;\n* Individuals with communication difficulties will be excluded.\n* Study participants who report suicidal behaviors during baseline data collection will be excluded.",true,"10 Years","14 Years",{"count":91,"type":21},700,[24],"The purpose of the study is to evaluate the impact of providing a skipping rope and informational pamphlet to adolescents aged 10-14 years on their physical activity intentions and behaviors from baseline to 12-month follow-up when compared with adolescents of the same age who are not provided with any intervention. This study comprises a two-arm randomized controlled trial nested within an adolescent cohort, i.e. a 'randomized trial-within-cohort'. The intervention will include providing each participant with a skipping rope and a pamphlet with general instructions for skipping the rope and messages about the importance of physical activity. The investigators hypothesize that adolescents in a South African community who are provided with a skipping rope and an informational pamphlet on physical activity will engage in more physical activity behaviors and will report greater intentions to be physically active at a 12-month follow-up, compared to a control group of adolescents who do not receive the intervention.",[95],"Moderate-vigorous Physical Activity (MVPA)",[97,98,99,100,101,102],"Physical activity","Skipping rope","Informational pamphlet","Young adolescents","Community","South Africa","2024-11-21",{"date":105,"type":40},"2024-11-22",{"date":107,"type":40},"2024-10-01",{"date":109,"type":21},"2025-12-30",{"name":46,"class":47},""]