[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Cape Town\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":340},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,69,96,122,147,171,202,241,267,291,315],{"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":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100636323","the-coach-mpilo-study-evaluation-of-a-peer-led-intervention-to-promote-engagement-in-hiv-care-for-men-living-with-hiv-100636323",false,"NCT07564193","The Coach Mpilo Study: Evaluation of a Peer-led Intervention to Promote Engagement in HIV Care for Men Living With HIV","The Coach Mpilo Study: Evaluation of a Peer-led Intervention to Promote Engagement in HIV Care for Men Living With HIV in South Africa","Inclusion Criteria:\n\n* Male (cisgender or transgender);\n* aged ≥18 years;\n* previously receiving HIV care at the study clinic;\n* missed their most recent ART (antiretroviral therapy) clinic appointment by \\>28 days;\n* not planning to relocate to another region within the next 12 months;\n* able and willing to provide informed consent;\n* not currently taking ART\n\nExclusion Criteria:\n\n* not meeting inclusion criteria","ALL","18 Years",{"count":19,"type":20},800,"ESTIMATED","INTERVENTIONAL",[23],"NA","Developed in South Africa using extensive input from community members and healthcare professionals, Coach Mpilo is a peer support intervention that was designed to improve health outcomes for men living with HIV. Coach Mpilo engages men living with HIV as coaches who provide support to their peers and help them address psychosocial barriers in accessing and staying in HIV care. The peers employed by Coach Mpilo provide individualized assistance to men who are struggling with medication adherence and clinic visits, focusing on specific barriers ranging from knowledge about the benefits of HIV treatment, stigma, mental health, and social isolation.\n\nThrough a randomised control trial, this project will (1) determine the impact of the Coach Mpilo intervention on retention in HIV care, viral suppression, HIV treatment adherence, mental health, HIV stigma, and economic status; (2) identify populations of men who may not benefit from the intervention and require alternative support; and (3) assess the intervention's cost-effectiveness.",[26],"HIV",[26,28,29,30,31,32,33,34,35],"antiretroviral therapy (ART)","re-engagement in HIV care","linkage to care","peer-support","Coach Mpilo","men living with HIV","South Africa","ARV","NOT_YET_RECRUITING","2026-05-06",{"date":39,"type":40},"2026-05-11","ACTUAL",{"date":39,"type":20},{"date":43,"type":20},"2027-09",{"name":45,"class":46},"University of Cape Town","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":47},"100439861","test-to-treat-tb-impact-of-sputum-sequencing-guided-individualised-therapy-on-outcomes-in-drug-resistant-tuberculosis-100439861","NCT05007795","Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis","Test to Treat TB: Impact of Sputum Sequencing-guided Individualised Therapy on Outcomes in Drug-resistant Tuberculosis (TB): a Proof of Concept Randomized Controlled Trial","T3-RCT","Inclusion Criteria:\n\nSubjects are required to meet ALL of the following inclusion criteria to participate:\n\n* Newly diagnosed culture and\u002For Xpert\u002FMTB Ultra positive pulmonary TB\n* Rifampicin resistance detected using GeneXpert\n* Provide written informed consent prior to all trial-related procedures\n* Male or female aged 18 years and older.\n* Patients on TB treatment for less than or equal to 7 days.\n* Patients receiving both the shorter and longer MDR-TB regimen will be eligible.\n\nExclusion Criteria:\n\nSubjects will be excluded from participation if they meet ANY of the following criteria:\n\n* A subject who in the opinion of the investigator is unlikely to cope with regular visits to the trial site either because of travel constraints, or drug or alcohol abuse, or other reason.\n* Currently on MDR-TB treatment and completed 7 days of treatment.\n* Any participant with a clinically significant pre-existing medical condition that, in the opinion of the investigator, may be significantly worsened by the patient's participation in the study\n* Any subject with a Karnofsky score \\\u003C 50.\n* Having participated in other clinical studies within 8 weeks prior to trial start where investigational agents were used that may potentially impact current trial outcome.\n* Participant who is pregnant, breast-feeding (and not willing to stop), or planning to conceive a child within 6 months of cessation of treatment.\n* Any pre-existing laboratory abnormality, which in the opinion of the investigator will place the participant at risk (see detailed protocol for grade of abnormality).",{"count":57,"type":20},280,[23],"Resistance to anti-tuberculosis drugs is a continually growing problem. Multidrug-resistant tuberculosis (MDRTB) is resistance to at least rifampicin and isoniazid, and extensively drug-resistant TB is additional resistance to a fluoroquinolone and a second injectable line drug. Methods currently employed in testing for resistance are inadequate and a contributing factor to the 40-50% MDR-TB treatment success rate. Current drug susceptibility testing methods are slow for most drugs, taking weeks. Rapid molecular methods such as the line probe assays, e.g. Hain GenoType MDRTBplus and sl, provide resistant calls to only a limited number of drugs, and are often less useful in smear negative patients.\n\nMolecular technologies such as sequencing can provide a comprehensive readout of drug resistance and are able to detect resistant populations at very low levels (≤1%), thus enabling individualized therapy. This can be done directly from sputum. Targeted sequencing amplifies regions of genomic DNA associated with resistance prior to sequencing. Rapid analytic software is used to process the raw sequence data, identify resistance causing mutations and provide a readout of clinically relevant information. However, the feasibility, and more importantly the impact, of this approach has not been evaluated in a clinical trial to establish proof of concept.\n\nAim 1: To conduct a randomised controlled trial to determine the impact of sputum-based targeted sequencing in detecting resistance to second-line TB drugs compared to the current programmatic standard of care (Hain MDRTBplus\u002Fsl and adjunct phenotypic drug susceptibility testing) when used to inform of treatment for MDR-TB.\n\nAim 2: To compare currently available drug resistant sequencing pipelines for diagnostic accuracy, sensitivity, specificity and predictive value as compared to culture based phenotypic drug susceptibility testing.\n\nAim 3: To compare the feasibility, accuracy, turn-aroundtime, and cost implications of the above-mentioned diagnostic approaches.",[61],"Tuberculosis, Multidrug-Resistant","2026-05-05",{"date":37,"type":40},{"date":65,"type":20},"2026-06-01",{"date":67,"type":20},"2028-10-30",{"name":45,"class":46},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":47},"100626740","choice-based-support-for-adults-starting-or-restarting-antiretroviral-therapy-in-cape-town-south-africa-100626740","NCT07439562","Choice-Based Support for Adults Starting or Restarting Antiretroviral Therapy in Cape Town, South Africa","Zikhethele - Choose For You Aim 3 Exploring the Feasibility, Acceptability and Preliminary Impact of Choice-based Antiretroviral Therapy (ART) Support Interventions for Adults Starting and Restarting ART in Cape Town, South Africa: A Pilot Randomised Controlled Trial","Zikhethele","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Living with HIV\n* Starting ART for the first time or restarting ART after an interruption of at least three months\n* Eligible to start or restart ART based on local guidelines\n* Clinically stable (no acute illness or evidence of TB\u002Fmeningitis)\n* English or isiXhosa speaking\n* Willing and able to provide informed consent to participate.\n\nExclusion Criteria:\n\n\\- Pregnancy at the time of enrolment",{"count":78,"type":20},140,[23],"Disengagement from HIV care is very common in the first year after starting or restarting antiretroviral therapy (ART). There is increasing recognition of people cycling in and out of HIV care over time people newly starting and restarting treatment after an interruption are at high risk of subsequent disengagement from care. While guidelines advocate for patient-centered models of care, patient preferences are often not considered fully in the design of interventions. Building on existing support intervention modalities, formative qualitative research and a stated preference survey, the investigators have designed a choice-based ART support intervention. The intervention offers a choice of a) in-person group support, b) low-touch WhatsApp support group, and c) individual digital support through the AI Coach chatbot.\n\nThis study will explore the feasibility, acceptability and preliminary impact of choice-based ART support for adults starting and restarting ART in Cape Town, South Africa, through a randomized pilot feasibility trial.\n\nThe objectives of this study are:\n\n1. To determine the feasibility, acceptability, appropriateness and fidelity of the Zikhethele intervention components, including offering patients a choice of ART support intervention.\n2. To describe the distribution of actual choices in the choice arm.\n3. To describe outcomes in each pilot trial arm and explore the preliminary impact of offering a choice, compared allocation to a support intervention or standard of care, on patient empowerment and treatment outcomes.\n4. To explore the hypothesised mechanisms of action and contextual moderators through in-depth interviews with participants and providers including consideration of patient empowerment, stigma and social support, and trust in provider, peers and digital tools.\n\nA total of 140 adults starting or restarting ART will be consecutively recruited and randomised to a) standard of care (n=35), b) in-person support (n=35) and c) a choice (n=70) of in-person support, WhatsApp group support, AI coach, or no additional support (standard of care).\n\nThe intervention components will run for the first four months after start or restart, through to the first viral load and eligibility assessment for routine differentiated models of care. Briefly, the in-person group support will consist of monthly informal and discussion-based sessions framed around chronic medication adherence (including HIV, diabetes, and hypertension), designed to create a safe and supportive space where participants can share experiences, problem-solve, and build motivation to remain in care. The WhatsApp group support will be a virtual adaptation of the in-person model, designed to provide an accessible, low-barrier option for participants who prefer remote or flexible engagement. The AI Coach is a pilot AI chatbot (developed by Audere, PSI, HSRC, and Matchboxology, and being piloted in Gauteng and KwaZulu Natal by HE2RO at the Wits Health Consortium) inspired by the in-person Coach Mpilo model-a peer navigator case management approach in South Africa that employs men living with HIV as \"coaches\" to support linkage, retention, and re-engagement in care. The AI coach is available anytime via WhatsApp, and offers trusted information (through a curated large-language model), and empathetic counselling and behavioural nudges to encourage healthy habits.\n\nIndividuals (aged 18 and older, living with HIV and currently attending the clinic to start ART for the first time or to restart after an interruption of 3 or more months) will be approached during their routine clinic visit by a trained research fieldworker. Eligible individuals will undergo informed consent and be enrolled. Participants will complete an interviewer administered questionnaire at enrolment and at four months. Outcome data will also be abstracted from paper and electronic medical records, as well study and intervention logs, intervention debriefings and chatbot logs. A subset of 20 participants, purposefully selected to include each intervention component, will be invited to complete an in-depth interview at 4 months. Providers (n=6), while not involved directly in this pilot implementation, will also be invited to participate in an in-depth interview to explore the potential of this intervention.\n\nThis exploratory pilot study serves as a proof-of-concept for offering people living with HIV different modalities of support for engagement in care in the first four months. The study is not powered for efficacy but will provide valuable insights into feasibility (of both the trial design and intervention components) and acceptability, as well as real-world preferences and trade-offs. The investigators hypothesize that those able to choose a support intervention most appealing or most fitting to their life circumstances may have improved health empowerment which may in turn improve health outcomes.",[82],"HIV Care Loss to Followup",[26,84,85,86,87],"antiretroviral therapy","engagement in care","patient choice","adherence support","2026-02-24",{"date":90,"type":40},"2026-02-27",{"date":92,"type":20},"2026-02",{"date":94,"type":20},"2026-08",{"name":45,"class":46},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":102,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":47},"100592738","5-rs-to-rescue-a-cluster-trial-with-an-embedded-process-evaluation-100592738","NCT06997328","'5 Rs to Rescue' A Cluster Trial With an Embedded Process Evaluation","Inclusion Criteria:\n\n* Patients aged 18 years and older undergoing any surgery, who receive postoperative care on a participating ward\n\nExclusion Criteria:\n\n* Patients who opt out of trial participation.\n* Patients receiving end of life care.","100 Years",{"count":104,"type":20},6000,"OBSERVATIONAL","'Failure to rescue' describes the preventable death of a patient following the absence of timely identification and treatment of a complication after surgery. The absence of systems contributes to the higher mortality post-surgery in Africa compared to high-income countries. To mitigate this, a complex quality improvement (QI) intervention has been designed focusing on improving five main areas of patient management following surgery termed as '5 Rs to Rescue'. The study will take place in 20 centers in 4 countries - Ethiopia, South Africa, Tanzania, and Uganda. This a multi-center, mixed methods, cluster trial with a baseline assessment to evaluate the efficacy of the QI intervention. To study is aimed to evaluate whether implementation of the '5 Rs to Rescue' quality improvement intervention increases surveillance for patients at risk of 'failure to rescue' after surgery in hospitals in Africa.\n\nThe '5 Rs to Rescue' includes:\n\n1. Risk assessment using the ASOS risk score for all surgical patients,\n2. Recognition of patient deterioration by regular, protocolized vital signs monitoring plus use of an Early Warning Score (EWS) system. 3. Response to deterioration by protocolized escalation based upon EWS plus protocolized care pathways for common complications (hypoxia, hypovolemia, sepsis). 4. Reassessment following deterioration by protocolized re-assessment based upon EWS, and 5. Reflection on care provided following a patient's deterioration or death using a structured review tool at regular reflection meetings.",[108,109],"Surgery","Failure to Rescue",[111,112],"Quality improvement","Postoperative Mortality","RECRUITING","2026-01-21",{"date":116,"type":40},"2026-01-23",{"date":118,"type":40},"2024-09-01",{"date":120,"type":20},"2026-09-01",{"name":45,"class":46},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},"100402556","phase-2-high-vs-standard-dose-rifampicin-for-effusive-tuberculous-pericarditis-100402556","NCT04521803","High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis","IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis","IMPI-3","Inclusion Criteria:\n\n1. Aged \\>18 years\n2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)\n3. Consent to study participation including testing for HIV-1 (if HIV status is unknown)\n4. Microbiologically detected Mtb in PCF or diagnosis of probable PCTB. Probable PCTB (in the absence of a positive pericardial fluid culture) will be defined as per Mayosi et al.4:\n\n   1. Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and\u002For\n   2. Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U\u002FL)\n5. Participant will undergo pericardiocentesis (as per clinical indication)\n6. Within 5 days of ATT initiation\n\nExclusion Criteria:\n\n1. Glomerular filtration rate \\\u003C30ml\u002Fmin or renal failure requiring dialysis\n2. Rifampin-resistant TB\n3. Severe concurrent opportunistic infection\n4. Contraindication to placement of intra-pericardial catheter\n5. Failed pericardiocentesis procedure and\u002For failure of placement of intra-pericardial catheter\n6. Any disease or condition in which the use of the standard anti-TB drugs (or any of their components) are contraindicated. This includes, but is not limited to, allergy to any TB drug or their components.\n7. In females: a positive urine pregnancy test result\n8. Confirmed autoimmune disorders (e.g. systemic lupus erythematosus)\n\nAdditional Exclusions for Gadolinium contrasted CMR\n\n1. Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)\n2. Claustrophobia\n3. Gadolinium allergy\n4. Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)\n5. Breastfeeding",{"count":131,"type":20},60,[133],"PHASE2","The investigators hypothesise that high dose RIF (RIF35) will increase pericardial fluid RIF exposure and so enhance mycobacterial clearance, compared to standard of care dosing (RIF10).\n\nThis Phase 2b randomized, placebo-controlled, double-blinded trial will evaluate the efficacy and safety of RIF 35mg\u002Fkg compared 10mg\u002Fkg, added to standard first-line ATT, for the treatment of PCTB.",[136,137],"Tuberculous Pericarditis","HIV Status","2025-08-15",{"date":140,"type":40},"2025-08-21",{"date":142,"type":40},"2022-01-10",{"date":144,"type":20},"2026-02-28",{"name":45,"class":46},2,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":17,"maxAge":157,"enrollmentInfo":158,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":146},"100567020","vaginal-microbiome-research-consortium-for-africa-100567020","NCT06662747","Vaginal Microbiome Research Consortium for Africa","Vaginal Microbiome Research Consortium for Africa - Pilot","VMRC4Africa","Inclusion Criteria:\n\n* Female at birth\n* Willing and able to provide informed consent for screening and cognitive ability to understand sampling procedures\n* Not pregnant\n* HIV negative on testing performed by study staff\n* 18-40 years old\n* Planning to stay in the area for the next 10 weeks\n* Able and willing to provide adequate locator information for study retention purposes\n* Willing and able to return for all 3 nurse visits and return self-swabs to the clinic weekly\n* Sexually active for the last 3 months defined as penetrative penile-vaginal intercourse at least once in the last 3 months\n\nExclusion Criteria:\n\n* Male at birth\n* Not willing to provide consent\n* Pregnant or actively trying to conceive\u002Fbecome pregnant in the next 10 weeks\n* Living with HIV or untreated STIs (CT, NG, TV) or bacterial vaginosis (Nugent \\> 3)\n* Currently taking antibiotics or having been on antibiotic treatment in the previous four weeks\n* \\\u003C18 or \\>40 years old\n* On chronic disease management for gynaecological conditions\n* Any medical condition or other factors which would preclude study participation as per principal Investigator's or designee's decision, including but not limited to cancer of the cervix\n* Any mental health condition which, in the opinion of the investigator, would preclude comprehension of informed consent, or preclude study participation\n* Currently enrolled on any other study prohibiting co-enrolment",true,"FEMALE","40 Years",{"count":159,"type":20},200,"1. To characterise vaginal microbial community dynamics (bacterial and fungal) from different geographies in Africa to understand the microbial diversity that occurs in women with stable L. crispatus-dominant versus unstable vaginal microbiota.\n2. To identify vaginal communities associated with low levels of inflammation in women from different geographies in Africa\n3. To examine prevalence and diversity of HPV types circulating in the different geographies and their interaction with the vaginal microbiota\n4. To create a biobank of stored samples that can be used in future studies and for the isolation of regionally representative bacterial strains.",[162],"Healthy","2025-08-01",{"date":165,"type":40},"2025-08-03",{"date":167,"type":40},"2021-10-15",{"date":169,"type":20},"2026-10-31",{"name":45,"class":46},{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":177,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100424919","remote-ischaemic-conditioning-in-stemi-patients-in-africa-100424919","NCT04813159","Remote Ischaemic Conditioning in STEMI Patients in AFRICA","Remote Ischaemic Conditioning in STEMI Patients in AFRICA: The RIC-AFRICA Trial","RIC-AFRICA","We will be recruiting 3 different strata of STEMI patients.\n\n1. Adult patients (≥18 years old) presenting with STEMI receiving thrombolytic therapy within guideline-recommended time (i.e., within \\\u003C12 hours of most severe chest pain onset).\n2. Adult patients (≥18 years old) presenting with STEMI who are ineligible for thrombolysis because they present outside of guideline-recommended time (\\\u003C12 hours) but within 24 hours of most severe chest pain onset.\n3. Adult patients (≥18 years old) presenting with evidence of STEMI who do not receive thrombolysis and who present ≥24 hours and within 72 hours of most severe chest pain onset.\n\nInterventional arm of the Study: Randomized Control Trial\n\nPatients who are deemed eligible for randomization into the trial on account of presentation with STEMI within 24 hours, will be eligible for the interventional arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Adult patients (≥18 years old) presenting with suspected STEMI (ST-elevation at the J-point in two contiguous leads ( ≥ 0.2mV in men or ≥ 0.15mV in women in leads V2-V3 and\u002For ≥ 0.1mV in other lead); and II. Within 24 hours of onset of myocardial infarction as deemed by the attending clinician; and III. Signed informed consent.\n\nExclusion criteria\n\nI. STEMI patients due to undergo primary percutaneous coronary intervention;\n\nII. STEMI patients presenting with cardiogenic shock or haemodynamic instability as defined by: systolic blood pressure (SBP) measurement of \\\u003C90 mm Hg for ≥30 minutes; or use of pharmacological and\u002For mechanical support to maintain SBP ≥ 90 mm Hg; and evidence of end-organ damage defined by: urine output of \\\u003C30 mL\u002Fh; altered mental status; and\u002For serum lactate \\>2.0 mmol\u002FL;\n\nIII. Contraindications for the use of RIC or sham-control on either arm such as:\n\n1. severe active skin disease\u002Fburns on both arms; or\n2. bilateral upper limb amputations; or\n3. evidence of acute limb ischaemia on either arm; or\n4. active upper limb gangrene of any digits;\n5. breast cancer with lymph-node involvement on the ipsilateral side of RIC; or\n6. bilateral arteriovenous fistulae needed for haemodialysis.\n\nIV. Inter-current disease with an expected life expectancy of less than 24 hours;\n\nV. Contra-indication to thrombolytic therapy in patients presenting within guideline-recommended time (\\\u003C12 hours).\n\nObservational arm of the study\n\nPatients who are deemed ineligible for randomization into the trial on account of presentation beyond 24 hours, will be eligible for the observational arm of the study if the following inclusion\u002Fexclusion criteria are met.\n\nInclusion Criteria\n\nI. Signed informed consent; and\n\nII. Clinical evidence of STEMI older than 24 hours and less than 72 hours as defined by:\n\n1. Compatible history with maximal chest pain between 24 -72 hours prior to presentation; and\n2. Compatible biomarkers (elevated cardiac troponin); and\n3. ECG compatible with recent STEMI; and\u002For\n4. Compatible echocardiography.\n\nExclusion criteria\n\nI. Refusal or inability to sign informed consent.",{"count":180,"type":20},1400,[23],"The RIC-AFRICA trial is a multi-centre, sham-controlled, randomised controlled trial (RCT) involving 1400 ST-segment elevation myocardial infarction (STEMI) patients presenting within ≤ 24 hours of myocardial infarction (MI) onset, across approximately 25 sites in 7 African countries (South Africa, Kenya, Sudan, Uganda, Mozambique, Senegal and Mauritius). Patients presenting with STEMI and deemed ineligible for the RIC AFRICA RCT because they present \\>24 hours from MI onset but less than 72 hours, will be recruited into the observational arm of the study with the same endpoints as the trial. The purpose of the RCT is to determine whether Remote Ischaemic Conditioning (RIC) can reduce the rates of all-cause death and early post-myocardial heart failure at 30-days in STEMI patients treated predominantly with thrombolytic therapy.",[184,185,186],"STEMI","Remote Ischaemic Conditioning","Myocardial Reperfusion Injury",[188,189,190,191,185,192,184],"Cardioprotection","Ischaemia\u002Freperfusion injury","ST-Elevation myocardial infarction","Hospitalisation for post-myocardial infarction heart failure","Cardiovascular mortality","2025-03-31",{"date":195,"type":40},"2025-04-03",{"date":197,"type":40},"2022-01-12",{"date":199,"type":20},"2027-12-31",{"name":45,"class":46},20,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":212,"conditions":213,"keywords":228,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":47},"100486132","gene-expression-profiles-in-spinal-tuberculosis-100486132","NCT05610098","Gene Expression Profiles in Spinal Tuberculosis.","Comparing Gene Expression Profiles of Adults With Isolated Spinal TB to Disseminated Spinal TB Identified by 18FDG-PET\u002FCT at Time of Diagnosis, 6-and 12-months Follow-up","SpinalTBX","Inclusion Criteria\n\n1. Participant has completed the written informed consent process prior to undergoing any clinical evaluations and willing to undergo HIV testing\n2. TB spine based on clinical and radiological criteria\n3. Age 18 or older with a body weight of at least 40 kg body weight\n4. Able and willing to return to follow-up\n5. Willing to have samples, including DNA including RNA extraction, stored\n6. Willing to consistently practice a highly reliable method of pregnancy prevention\n\nExclusion Criteria\n\n1. Pregnancy or active desire to become pregnant within the next 6 months.\n2. Uncontrolled diabetes (HbA1c ≥ 6.5% \u002F random glucose concentration ≥11.1 mmol\u002Fl, fasting plasma glucose ≥ 7.0 mmol\u002Fl)\n3. Alcohol and substance abuse which might interfere with medication adherence during the trial\n4. Positive SARS-CoV-2 PCR in the past 4 weeks\n5. Suspicion of malignancy on MRI or known malignancy\n6. Suspicion of inflammatory disease and other rheumatological conditions\n7. Any person for whom the physician feels this study is not appropriate",{"count":211,"type":20},100,"Tuberculosis (TB) is one of the top ten causes of death worldwide with approximately 10 million cases globally and 1.2 million deaths. Sub-Saharan Africa carries the highest burden of TB. South Africa has one of the highest HIV and TB rates worldwide with an HIV prevalence rate in adults of 19% and a TB case notification rate of 615\u002F100,000 in 2019. Over many years, focus has been paid to pulmonary TB and extrapulmonary TB (EPTB) has received only little attention even though it accounts for almost a quatre of all TB cases. The diagnosis of EPTB remains challenging simply because sample collection requires invasive procedures in the absence of a blood-based diagnostic test. Spinal TB (spondylitis or spondylodiscitis caused by Mycobacterium tuberculosis) - often known as Pott's disease - accounts for up to 10% of EPTB and affects young children, people with HIV-coinfection and elderly, and often leads to lifelong debilitating disease due to devastating deformation of the spine and compression of neural structures. Little is known with regards to the extent of disease and isolated TB spine as well as a disseminated form of TB spine have been described. The latter presents with a spinal manifestation plus disseminations to other organs such as the lungs, pleura, lymph nodes, the GIT or urinary tract or even the brain.\n\nIn the Spinal TB X cohort, the investigators aim to describe the clinical phenotype of spinal TB using whole body PET\u002FCT and identify a specific gene expression profile for the different stages of dissemination and compare findings to previously described signatures for latent and active pulmonary TB. A blood-based test for spinal TB would lead to earlier diagnosis and treatment in all settings globally and improve treatment outcome of this devastating disease.",[214,215,216,217,218,219,220,221,222,223,224,225,226,227],"Tuberculosis, Spinal","Tuberculosis, Osteoarticular","Tuberculosis","Mycobacterium Infections","Infections","Bone Diseases, Infectious","Musculoskeletal Diseases","Spinal Disease","Spondylitis","Spondylitis; Tuberculosis (Manifestation)","Spondylodiscitis","Positron-Emission Tomography","Diagnostic Imaging","Diagnostic Techniques and Procedures",[229,230,231,232],"Spinal TB","tuberculous spondylodiscitis","FDG-PET\u002FCT","POC","2024-08-22",{"date":235,"type":40},"2024-08-23",{"date":237,"type":40},"2022-10-25",{"date":239,"type":20},"2026-12-31",{"name":45,"class":46},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":47},"100373810","phase-2-atorvastatin-to-reduce-inflammation-after-tuberculosis-treatment-completion-100373810","NCT04147286","Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion","Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Safety and Efficacy of Atorvastatin to Reduce Inflammation After Tuberculosis Treatment Completion in HIV-infected and HIV-uninfected Adults Measured by FDG-PET\u002FCT","StatinTB","Inclusion Criteria\n\n1. Has completed the written informed consent process prior to undergoing any pre-screening or screening evaluations and willing to undergo HIV testing\n2. Age 18 to 65 years with body weight from 50 kg to 90 kg\n3. Clinical response to TB treatment and sputum culture negative at week 16\n4. Completed a 24-week course of standard TB treatment (4RHZE\u002F2RH)\n5. Defined as \"cured\" by the TB Control Program of South Africa\n\n   Laboratory parameters within 30 days before enrolment:\n6. For HIV-infected participants: receiving antiretroviral therapy for at least 12 weeks and suppressed HIV viral load within 30 days prior to enrolment\n7. For HIV-infected participants: CD4 counts above 350 cells\u002FµL within 30 days prior to enrolment\n8. AST and ALT \\\u003C3x upper limit of normal (ULN)\n9. Creatinine \\\u003C2x ULN\n10. Hemoglobin \\>7.0 g\u002FdL\n11. Platelet count \\>50 x109 cells\u002FL\n12. Creatinine kinase \\\u003C2x ULN\n13. Able and willing to return to follow-up\n14. Willing to have samples, including DNA, stored\n15. Willing to consistently practice a highly reliable method of pregnancy prevention\n\nExclusion criteria\n\n1. Acute illness\n2. Fever (temperature \\>38.0 degrees centigrade)\n3. Participant receiving any type of lipid lowering agent at the time of screening, within three months prior to screening or likely to require any lipid lowering agent in the near future.\n4. Known allergy or contraindications to the investigational drug or any other statins\n5. Evidence of drug-resistant TB\n6. Extrapulmonary TB, including pleural TB and\u002For large pleural effusion\n7. Pregnant or desiring\u002Ftrying to become pregnant in the next 6 months\n8. Unable to take oral medications\n9. Diabetes as defined by point of care HbA1c≥6.5, random glucose≥200mg\u002FdL (or 11.1mmol\u002FL), fasting plasma glucose≥126mg\u002FdL (or 7.0mmol\u002FL), or the presence of any anti-diabetic agent (including traditional medicines) as a concomitant medicine\n10. Disease complications or concomitant illnesses that may compromise safety or interpretation of trial endpoints, such as known diagnosis of chronic inflammatory condition (e.g. sarcoidosis, rheumatoid arthritis, connective tissue disorder)\n11. Use of immunosuppressive medications, such as TNF-alpha inhibitors or systemic or inhaled corticosteroids, within the past 2 weeks\n12. Use of any investigational drug in the previous 3 months\n13. Alcohol and substance abuse which might interfere with medication adherence during the trial\n14. Any person for whom the physician feels this study is not appropriate","65 Years",{"count":251,"type":20},220,[133,253],"PHASE3","This is a proof-of-concept phase IIB, double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of 40 mg atorvastatin to reduce persistent lung inflammation after successful TB treatment completion in HIV-infected and HIV-uninfected adults measured by PET\u002FCT.",[256],"Tuberculosis, Pulmonary",[258,26,259,260],"tuberculosis","COPD","inflammation",{"date":235,"type":40},{"date":263,"type":40},"2020-07-14",{"date":265,"type":20},"2027-09-30",{"name":45,"class":46},{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":155,"sex":16,"minAge":275,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":21,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100551942","brain-in-people-living-with-hiv-study-100551942","NCT06466642","B.R.A.I.N in People Living With HIV Study","Building Resources to Achieve Improvement in Neurocognition (B.R.A.I.N) in People Living With HIV","BRAIN","Inclusion Criteria:\n\n* Aged between 30 and 50 years;\n* ≥ 8 years of schooling;\n* Fluent Xhosa speaking;\n* HIV-positive;\n* on Antiretroviral therapy (ART);\n* ability to sign informed consent;\n* willing to attend: (a) two NP testing sessions, (b) a minimum of 10 hours (twenty 30-minute sessions) of R-CR sessions, and (c) 10 CogSMART sessions over a period of five weeks; and\n* meeting the criteria for NCI (as described further in document).\n\nExclusion Criteria:\n\n* Participants with significant neuro-medical comorbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, intellectual disability) necessitate exclusion. These comorbidities will be assessed for during screening.\n* Other conditions (e.g., legally blind or deaf, currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes) that could impact cognitive functioning, testing or consistent study participation over 7 weeks necessitate exclusion; again, this information is conferred in the screen.","30 Years","50 Years",{"count":278,"type":20},43,[23],"People living with HIV (PLWH) often have memory and thinking problems, which can range from mild to severe. These problems, which are called neurocognitive impairment (NCI), can appear even when PLWH are taking medicine to manage their HIV.\n\nPLWH who are experiencing NCI can have difficulties managing everyday activities. For instance, they might not remember to take their medicine on time, they might struggle to manage their money properly, and they might even be at a higher risk of passing HIV on to other. Ultimately, PLWH who are experiencing NCI might not enjoy life as much as others do.\n\nCurrently, there are no specific medicines designed to treat NCI in PLWH. There are, however, some useful memory and thinking strategies that can help improve cognitive abilities. These strategies are called cognitive remediation (CR).\n\nIn South Africa, there are many PLWH. Unfortunately, the country does not have clear plans for identifying and managing NCI in PLWH. It's difficult to use CR in South Africa because of cultural differences between where the strategies were developed and the patients who might need to use it, limited healthcare resources, and HIV clinics not having enough information about NCI.\n\nThere are, however, some promising ways to deal with these issues. For example, it can be helpful to involve regular counselors and to use simple tests on mobile phones to find people who need assistance. With some effort and creativity, investigators can improve the situation and help PLWH lead better lives.\n\nThe proposed study is a unique opportunity to find new ways to help PLWH and others with brain-related diseases who might be experiencing NCI. Investigators want to explore ways to use cognitive exercises to improve thinking abilities. This study will be the first of its kind because investigators will adapt these exercises to fit the cultures and languages of South Africa, where many people are affected by HIV and NCI.\n\nBy doing this research, investigators hope to make important progress in addressing NCI in HIV and similar conditions. Investigators will learn how to make these cognitive exercises work best in South Africa's public clinics, and this knowledge can help people with NCI live better lives. Our goal is to improve healthcare not only in South Africa but also in other parts of the world that might be facing similar challenges with improving the lives of PLWH.",[282],"HIV-associated Neurocognitive Disorders","2024-08-21",{"date":235,"type":40},{"date":286,"type":40},"2023-01-16",{"date":288,"type":20},"2024-12-31",{"name":45,"class":46},3,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":155,"sex":16,"minAge":299,"maxAge":276,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":47},"100510199","b-infantis-supplementation-to-improve-immunity-in-infants-exposed-to-hiv-100510199","NCT05923333","B. Infantis Supplementation to Improve Immunity in Infants Exposed to HIV","Bifidobacterium Infantis Supplementation in Early Life to Improve Immunity in Infants Exposed to HIV: a Randomized, Placebo-controlled, Double-blind Trial","BifIID","Inclusion Criteria Mother:\n\n* Willing and able to provide signed and dated informed consent form\n* 18 years of age or older\n* Documented HIV seropositive\n* Antiretroviral therapy initiated before the third trimester of pregnancy\n* Planning on exclusively breastfeeding the infant for the first 6 months of life\n\nInclusion Criteria Infant:\n\n* Documented HIV seronegative at birth\n* Born at term (completed at least 37 weeks of gestation)\n* Birth weight \\>2.4kgs\n\nExclusion Criteria:\n\n* Severe illnesses, e.g. Sepsis\n* current TB or known household TB contact\n* Chronic disorder or medications (other than antiretrovirals and cotrimoxazole prophylaxis) that in the opinion of the investigator would alter immunity\n* Pregnancy or delivery complications including birth asphyxia, seizures, sepsis, major congenital anomalies or congenital infections\n* Known contraindications to components of the interventional products\n* Taking additional probiotics or prebiotics\n* Any condition that in the opinion of the investigator would make participation in the trial unsafe","0 Days",{"count":159,"type":20},[23],"The primary objectives of this study are to evaluate the effect of early-life B. infantis Rosell®-33 supplementation in infants exposed to HIV on:\n\n* gut microbiome composition and diversity at 4 weeks of life\n* markers of intestinal inflammation and microbial translocation at 4 weeks of life\n* Th1 cytokine responses to BCG at 7 weeks and 36 weeks of life\n\nThe secondary objectives include to evaluate the effect of B. infantis Rosell®-33 supplementation on:\n\n* longitudinal succession of the gut microbiota composition, diversity and function\n* relative and absolute abundance of B. infantis in infant stool during the first 36 weeks of life\n* stool metabolome\n* T cell subset ontogeny during the first 9 months of life.\n\nExploratory objectives are to evaluate whether B. infantis Rosell®-33 supplementation improves:\n\n* infant growth\n* all-cause morbidity\n* neurodevelopment during the first 9 months of life\n* antibody responses to early childhood vaccines",[304,305,306,307],"Hiv","Vaccine Reaction","Microbial Colonization","Infant Development","2024-08-20",{"date":233,"type":40},{"date":311,"type":40},"2023-08-11",{"date":313,"type":20},"2027-06",{"name":45,"class":46},{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":156,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":113,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":47},"100491356","point-of-care-ultrasound-abnormalities-in-eclampsia-100491356","NCT05678062","Point-of-care Ultrasound Abnormalities in Eclampsia","Point-of-care Ultrasound Abnormalities in Eclampsia - Prevalence and Association Between Pulmonary Interstitial Syndrome and Cardiac Dysfunction, Brain Natriuretic Peptide, and Serum Albumin","Inclusion Criteria:\n\n* Diagnosis of preeclampsia following ACOG definition with new onset of tonic-clonic seizures.\n\nExclusion Criteria:\n\n* Chronic pulmonary disease\n* Collagen disorders\n* HIV infection if CD4 count \\\u003C200 cells\u002F mm3\n* Chronic renal or hepatic disease\n* Urinary tract infection\n* Sepsis\n* Body mass index (BMI) \\> 50 kg\u002Fm2\n* History of seizure disorder\n* Intracranial haemorrhage\n* History of benign or malignant intracranial neoplasia",{"count":323,"type":20},70,[23],"Preeclampsia (PE) and eclampsia remain leading causes of maternal morbidity and mortality, in both high-, low-and-middle-income countries. Preeclampsia is a complex, multisystem disease which, in its severe form, affects the cardiovascular, renal, hepatic, neurological and haematological systems. Given the complexity of the disease, anaesthesia management for caesarean section in these patients remains challenging. Preeclampsia may be complicated by the development of eclampsia, which involves one or more seizures, which complicates anaesthesia and obstetrics management, and requires. urgent admission and delivery. Recent studies have demonstrated novel markers of severity of PE, including point-of-care ultrasound (POCUS), acid-base changes secondary to low serum albumin, and brain natriuretic peptide (BNP). POCUS is playing an increasing role in perioperative diagnosis, and newer, less expensive devices are continuously being developed. These will in all likelihood play an important role in South Africa in the near future. In a recent trial performed at the University of Cape Town, a comprehensive acid-base analysis in women with PE with severe features demonstrated significant abnormalities in independent acid-base determinants. In addition, strong indications were found that changes in acid-base status following a decrease in serum albumin are more pronounced in early onset PE and may be associated with urgent delivery. In other clinical arenas in critically ill patients, low serum albumin is associated with increased lung water, increased intracranial pressure, and outcome. The research team hypothesised that similar associations might be found in women with late onset preeclampsia with severe features. Using POCUS, it was found that there was no association between serum albumin level and PIS or optic nerve sheath diameter (ONSD). PIS was however associated with cardiac dysfunction, as was BNP.",[327],"Eclampsia",[329,330,331],"Pulmonary interstitial syndrome","Cardiac dysfunction","Brain natriuretic peptide","2024-07-15",{"date":334,"type":40},"2024-07-17",{"date":336,"type":40},"2022-11-21",{"date":338,"type":20},"2024-12",{"name":45,"class":46},""]