[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Obafemi Awolowo University Teaching Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,86,109,128],{"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":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100616291","phase-2-atorvastatin-in-pulmonary-tuberculosis-a-population-pharmacokinetics--pharmacodynamics-sub-study-atortub-poppk-pd-100616291",false,"NCT07303699","ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)","Population Pharmacokinetics and Pharmacodynamics of Standard First Line Anti-TB Versus Atorvastatin-Containing Regimens in the Treatment of Pulmonary Tuberculosis: A Sub-study of the ATORTUB Phase 2C Randomized Controlled Trial (ATORTUB popPK-PD Study)","Inclusion Criteria:\n\n* Sputum specimen positive for tubercle bacilli on Gene Xpert or direct smear microscopy\n* Either no previous anti-TB chemotherapy, or less than 2 weeks of previous chemotherapy\n* Aged 12years and above\n* A firm home address that is readily accessible for visiting\n* Agreement to participate in the study and to give a sample of blood for HIV testing\n* Normal baseline laboratory values at or within 14 days prior to screening:\n\n  * Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal\n  * Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal\n  * Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal\n  * Serum or plasma potassium level greater than or equal to 3.5 meq\u002FL\n  * Hemoglobin level of 7.0 g\u002FdL or greater\n  * Platelet count of 100,000\u002Fmm3 or greater\n* Informed consent to participate in the study and to give a sample of blood for HIV testing\n\nExclusion Criteria:\n\n* Participants known or suspected of having any form of drug resistance TB.\n* Patients co infected with HIV\n* Those with poor general condition where no delay in treatment can be tolerated\n* Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.\n* Known or family history of bleeding disorders.\n* Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.\n* Myositis and or Creatinine phosphokinase three times upper limit of normal\n* Patient in a moribund state\n* Has TB meningitis\n* Presence of any of the pre-existing non-TB diseases outlined in the protocol\n* Diabetes mellitus\n* Hypertension\n* Currently on anti TB medication\n* Any other chronic illness\u002F co morbidities that warrants being on daily routine medications\n* Presence of a psychiatric illness\n* pregnant, or breast feeding mothers\n* Current Tobacco Smokers\u002F tobacco use in any form\n* Alcoholism\n* alcoholic beverages, food or drinks containing methyl- xanthine (i.e. energy drinks, tea leaves, coffee beans, cocoa, kola nuts, medications e.g. theophylline). Ingestion of grapefruit\u002F products containing grapefruit juice, bitter oranges, garlic supplements, St John's Wort or other herbal supplements, within 7 days prior to the first treatment and throughout the study will not be allowed.\n* Individuals that are enrolled in other therapeutic clinical trials","ALL","12 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK\u002FPD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.",[26],"Pulmonary Tuberculosis (TB)",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Pulmonary TB","Pulmonary Tuberculosis","Tuberculosis","Koch's disease","Mycobacterium tuberculosis","Isoniazid","Atorvastatin","Rifampicin","Rifampin","Ethambutol","pyrazinamide","Intensive Phase","Continuation Phase","statins","Antitubercular therapy (ATT)","RECRUITING","2026-01-21",{"date":46,"type":47},"2026-01-23","ACTUAL",{"date":49,"type":20},"2026-01-03",{"date":51,"type":20},"2028-03-30",{"name":53,"class":54},"Obafemi Awolowo University Teaching Hospital","OTHER",3,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":16,"minAge":17,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},"100531447","phase-2-atorvastatin-in-pulmonary-tuberculosis-100531447","NCT06199921","ATORvastatin in Pulmonary TUBerculosis","Atorvastatin-containing Treatment Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled phase2C\u002F3 Clinical Trial","ATORTUB","Inclusion Criteria:\n\nIndividuals must meet all the following inclusion criteria in order to participate in this study:\n\nA. Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB\u002FRIF testing, with semiquantitative result of 'medium' or 'high' and rifampicin resistance not detected.\n\nB. Treatment naive\n\nC. Age twelve years or older\n\nD. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period.\n\nE. Documented HIV infection status.\n\nF. Documented blood sugar level\u002F Diabetes\n\nG. For HIV-positive individuals, CD4 T cell count greater than or equal to 100 cells\u002Fmm3 based on testing performed at or within 30 days prior to screening.\n\nH. Laboratory parameters done at or within 14 days prior to screening:\n\n* Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal\n* Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal\n* Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal\n* Serum or plasma potassium level greater than or equal to 3.5 meq\u002FL\n* Hemoglobin level of 7.0 g\u002FdL or greater\n* Platelet count of 100,000\u002Fmm3 or greater\n\nI. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening\n\nJ. Written informed consent\n\nExclusion Criteria:\n\nIndividuals with any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded.\n\nA. Pregnant or breast-feeding\n\nB. Unable to take oral medications\n\nC. Those already on treatment for tuberculosis\n\nD. Weight less than 40.0 kg\n\nE. Known allergy or intolerance to any of the study medications\n\nF. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide,or ethambutol,\n\nG. .Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.\n\nH. Known or family history of bleeding disorders. I. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.\n\nJ. Myositis and or Creatinine phosphokinase three times upper limit of normal K. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.\n\nCriteria for Exclusion after Enrollment ('Late Exclusion')\n\nMicrobiological confirmation of drug-susceptible tuberculosis is not expected always to be available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria will be classified as 'late exclusions' and study treatment will be discontinued:\n\nA. Screening, baseline, and Week 2 study visit sputum cultures all fail to grow M. tuberculosis.\n\nB. M. tuberculosis cultured or detected through molecular assays (Cepheid Xpert MTB\u002FRIF or Hain MTBDRplus assays) from sputum obtained around the time of study entry is determined to be resistant to one or more of isoniazid, rifampin, or fluoroquinolones.",true,"65 Years",{"count":67,"type":20},440,[23],"Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development.\n\nEmerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies.\n\nThis phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.",[29,30,71],"Koch's Disease",[34,73,74,75,76],"Anti-tuberculosis","HMG-COA Inhibitor","Statins","Anti TB drugs","2025-09-21",{"date":79,"type":47},"2025-09-25",{"date":81,"type":47},"2024-01-03",{"date":83,"type":20},"2026-09-30",{"name":53,"class":54},8,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100492004","building-capacity-for-screening--early-diagnosis-of-colorectal-cancer-through-a-comprehensive-colonoscopy-training-program-in-nigeria-100492004","NCT05686499","Building Capacity for Screening & Early Diagnosis of Colorectal Cancer Through a Comprehensive Colonoscopy Training Program in Nigeria","Inclusion Criteria:\n\n* Age \\>18\n* Health care professionals will include consultants and registrars in medicine, surgery, and gastroenterology\n\nExclusion Criteria:\n\n* Participants under the age of 18\n* Participants unwilling to sign consent","18 Years",{"count":94,"type":20},20,[96],"NA","This protocol seeks to develop a colonoscopy training program in Nigeria in order to increase the number of health care providers proficient in colonoscopy. The goal is to improve capacity for screening and early diagnosis of colorectal cancer (CRC) by training and expanding the healthcare workforce that is competent in endoscopy techniques. The project has three components, a needs assessment, simulation training, and training on live patients.\n\nThe first part of this project determines the number of providers and endoscopy procedures currently performed in Nigeria, as well as patient access to facilities that have colonoscopy capabilities, through a mixed methods approach. Surveys, focus in-depth interviews with key stakeholders, and use geographic information system (GIS) modeling technology will be employed to perform a needs assessment. The second component of this project investigates whether a locally developed low fidelity (LF) simulation colonoscopy training model is an effective teaching, training, and assessment tool for skill acquisition and confidence compared to a high-fidelity (HF) colonoscopy model. The third component of this project is training healthcare providers on real patients who have an indication for colonoscopy. This project seeks to build capacity for endoscopy services in order to increase capacity for screening and early diagnosis of CRC. At the end of the project, it is expected the number of providers trained to perform colonoscopy in a resource limited setting like Nigeria will increase.",[99],"Colon Cancer","2025-03-18",{"date":102,"type":47},"2025-03-21",{"date":104,"type":47},"2024-03-09",{"date":106,"type":20},"2026-12-31",{"name":53,"class":54},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":64,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":126,"locationsCount":127},"100442692","case-control-study-to-identify-modifiable-risk-factors-for-colorectal-and-breast-cancer-in-nigeria-100442692","NCT05044689","Case Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria","Case Group - Patients must have histologically confirmed diagnosis of colorectal or breast cancer.\n\nControl Group - Patients must not have a diagnosis of cancer.",{"count":116,"type":20},800,"OBSERVATIONAL","This project is a case-control study which seeks to identify modifiable risk factors for breast and colorectal cancer in Nigeria. Both cases and controls will be required to complete a risk factor questionnaire which contains information about their diet, physical activity, past medical history and life style factors. They will also be required to provide information on their body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water percentage.\n\nBased on the existing ARGO platform where a current colorectal cancer study is going on, approximately 400 patients with a prior diagnosis or a new diagnosis will be recruited into this study. Comparatively, we will select our 400 controls from two groups of participants who are free of cancer and gastrointestinal diseases.",[120,121],"Colorectal Cancer","Breast Cancer",{"date":102,"type":47},{"date":124,"type":47},"2021-04-12",{"date":106,"type":20},{"name":53,"class":54},1,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":92,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":4},"100556992","phase-3-comparative-study-between-platelet-rich-plasma-and-steroid-injection-in-trigger-finger-treatment-100556992","NCT06532318","Comparative Study Between Platelet Rich Plasma and Steroid Injection in Trigger Finger Treatment","Comparative Study Between Intralesional Injection of Platelet Rich Plasma and Intralesional Steroid for the Treatment of Trigger Finger in Black Patients","Inclusion Criteria:\n\n* Patients who are 18year and above with mild or moderate trigger finger, who are willing to have intra-lesional administration of blood product.\n\nNo previous treatment for the affected finger.\n\nExclusion Criteria:\n\n* Previous steroid injection\n* Previous Surgery to that finger\n* Thrombocytopenic patients\n* Hand and finger contracture\n* Rheumatoid arthritis of the finger",{"count":136,"type":20},40,[138],"PHASE3","The goal of this clinical trial is to learn if platelet rich plasma works to treat early stage trigger finger in adults. It will also learn about the safety platelet rich plasma. The main questions it aims to answer are:\n\nDoes platelet rich plasma lower the pain associated with trigger finger of participants? Does it improve the hand grip strength and Q DASH score of participants? Researchers will compare platelet rich plasma to Depo-Medrol steroid (a known standard of care for early stage trigger finger) to see if platelet rich plasma works to treat early trigger finger.\n\nParticipants will:\n\nTake platelet rich plasma or a depo-medrol steroid intralesional injection at recruitment into the intervention Visit the clinic once every 4 weeks for checkups and parameter measurements. Investigator will will keep a record of participants progress in symptom remission",[141],"Trigger Finger Disorder","NOT_YET_RECRUITING","2024-07-31",{"date":145,"type":47},"2024-08-01",{"date":147,"type":20},"2024-07-24",{"date":149,"type":20},"2025-06-23",{"name":53,"class":54},""]