Zaria

Tuberculosis TB is a serious infectious disease caused by Mycobacterium tuberculosis, leading to millions of cases and deaths worldwide, particularly in developing countries like Nigeria. TB mainly affects the lungs and is worsened by HIV infection, making it a top cause of death globally. The trial investigates atorvastatin, a cholesterol-lowering drug, to see if it can improve TB treatment by reducing bacteria and lung damage, building on promising earlier studies that showed atorvastatin was safe and may enhance TB therapy outcomes. The trial is a phase IIC, multicenter, randomized, open-label study comparing four treatment groups three different daily doses of atorvastatin 20mg, 40mg, 60mg given for 16 weeks along with standard 6-month anti-TB therapy, and a control group receiving standard therapy alone. Patients are randomly assigned to one of these groups and followed closely for 12 months after starting treatment. The study aims to evaluate safety, the speed at which TB bacteria clear from sputum, improvement in chest X-rays, and lung function. Participants aged 12 to 65 with active pulmonary TB will undergo screening including medical history, HIV and diabetes testing, sputum cultures, blood tests, lung function, and pregnancy tests for women. During the study, sputum samples, blood tests, chest X-rays, and lung function will be monitored regularly. Researchers will track side effects and measure outcomes like TB disease-free survival and symptom improvement at 6 and 12 months. The long follow-up period allows for detailed assessment of treatment effects and safety.

Researchers are studying how atorvastatin, a drug commonly used to lower cholesterol, behaves in the body when combined with the standard first-line treatment for drug-sensitive pulmonary tuberculosis TB in adults. The goal is to understand the drugs pharmacokineticsthe way it is absorbed, distributed, metabolized, and eliminatedand to develop a model that helps find the best dose of atorvastatin to use alongside TB treatment. This study is a phase 2, randomized trial conducted as a sub-study of the larger ATORTUB trial. Participants will be randomly assigned to one of four groups. Three groups will receive standard anti-TB therapy for 24 weeks combined with daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The fourth group will receive only the standard anti-TB therapy without atorvastatin. The standard TB treatment includes 8 weeks of rifampicin, isoniazid, pyrazinamide, and ethambutol followed by 16 weeks of rifampicin and isoniazid. This parallel dose comparison aims to identify the optimal atorvastatin dose for future TB treatment studies. Participants will attend several study visits over a total of 52 weeks, including 24 weeks of treatment followed by 6 months of follow-up. At each visit, sputum samples, chest X-rays, lung function tests, and blood samples for pharmacokinetic analyses will be collected. Researchers will measure key drug levels such as area under the curve AUC, peak plasma concentration, and plasma clearance for atorvastatin and TB drugs. The study will also evaluate how these drug levels relate to early bactericidal activity, sputum culture conversion, chest X-ray improvement, and lung function changes. Safety and optimal dosing will be assessed throughout the trial.

Benign prostatic hyperplasia BPH is a common condition affecting many men as they age, often leading to lower urinary tract symptoms LUTS. Due to a growing and aging population, the number of men diagnosed with BPH continues to rise, making treatment for this condition one of the most performed surgical procedures in urology. This research aims to establish a global, ongoing registry that collects detailed demographic and clinical data on men undergoing medical or surgical treatments for BPH to better understand treatment patterns and outcomes worldwide. The registry records information from men aged 18 and older with a primary diagnosis of BPH and LUTS who are receiving either medication or surgical intervention. Data collected includes baseline demographics, peri-operative details, and follow-up outcomes with no actual interventions performed by the registry team. The study uses validated patient-reported outcome measures like the International Prostate Symptom Score IPSS, Sexual Health Inventory for Men SHIM, and Male Sexual Health Questionnaire for Ejaculatory Dysfunction MSHQ-EjD, along with clinical data such as quality of life, urine flow rates, prostate-specific antigen levels, and complications related to treatment. Participants provide data over a period of three years with ongoing follow-up and no fixed end date, allowing for long-term observation of treatment effectiveness and safety. The registry also ensures data security and quality through encryption, user access controls, and regular audits. Researchers will analyze outcomes including symptom scores, quality of life, post-void residual urine, and complications like incontinence, bleeding, urinary tract infections, and erectile dysfunction, aiming to inform future BPH management and research.

This research aims to understand the genetic and environmental factors, especially the degree of African ancestry, that may influence the effects of maintenance treatment in women with ovarian cancer. The study focuses on testing an investigational drug called niraparib, which blocks cancer cells from repairing their damaged genes, making it harder for them to grow and spread. Participants will receive niraparib as a maintenance therapy for up to 24 cycles, each lasting 28 days. The drug is taken daily by mouth at one of three doses determined by individual health factors. After finishing the treatment, participants will be followed for up to one year, making the total participation time about three years. During the study, participants will provide saliva, blood, and tumor samples for genetic testing. They will be monitored regularly for side effects, treatment response, and quality of life using questionnaires. Researchers will track the occurrence of adverse events and measure how long participants remain free from cancer recurrence. Safety and drug metabolism will be assessed over the study period.

Researchers are studying genetic modifiers in hemoglobinopathies, including sickle cell disease and beta-thalassemia, through a large-scale, multi-ethnic genome-wide association study GWAS. These diseases vary widely in severity, influenced partly by genetic factors. The study aims to discover new genetic modifiers, validate known ones, pool existing genomic data, standardize disease descriptions, create a comprehensive research resource, and develop risk scores to help stratify patients based on disease severity and treatment response. The study will collect blood samples during routine clinical visits to perform GWAS experiments on individuals with hemoglobinopathies. Participants include those with various genotypes of sickle cell disease, beta-thalassemia, and alpha-thalassemia, without restrictions on gender or ethnicity. All participants will provide consent, and DNA samples may be collected if not already available in existing biobanks. Participants will contribute data including genetic, phenotypic, and functional information. The study will analyze worldwide patient demographics, genotypes, and disease severity. Researchers will investigate genetic modifiers related to survival, neurological function, renal impairment, pain syndromes, pulmonary hypertension, and treatment responses. This observational study involves data collection over five years, with no investigational treatments administered.