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This research aims to study breast cancer treatment specifically for Nigerian women who have HER2-positive breast cancer. The focus is on evaluating the effectiveness and safety of anti-HER2 therapies given before and after surgery. The study is designed to understand how these targeted treatments work in this population and to improve cancer care. Participants will receive a combination of anti-HER2 drugs, including trastuzumab with pertuzumab (PHESGO), alongside chemotherapy drugs such as docetaxel and trastuzumab emtansine. Hormone therapies like tamoxifen, letrozole, and goserelin are also part of the treatment plan. Treatments are given both before surgery (neoadjuvant phase) and after surgery (adjuvant phase) to assess their impact on the cancer. Throughout the study, participants will undergo regular assessments including biopsies, ultrasounds, blood tests, and heart function tests to monitor safety and treatment effects. Researchers will track the pathological complete response over a 10-year period to measure long-term outcomes. The study includes thorough safety checks and follow-up visits to ensure participants' well-being during and after treatment.

Tuberculosis (TB) is a serious infectious disease causing millions of cases and deaths globally, with a high burden in developing countries like Nigeria. TB mainly affects young adults and is worsened by HIV infection. Current TB treatments are long and challenging, leading to poor compliance and drug resistance. Researchers are studying whether atorvastatin, a cholesterol-lowering drug, can improve TB treatment by making the bacteria more vulnerable and reducing lung damage. Previous Phase II studies showed atorvastatin to be safe and possibly effective, warranting further investigation in this Phase IIC trial. This trial is a multicenter, randomized, open-label study comparing four treatment arms: standard TB drugs alone or combined with daily atorvastatin at doses of 20 mg, 40 mg, or 60 mg for 16 weeks. All participants receive standard anti-TB treatment for 24 weeks. The study will evaluate safety, how quickly the bacteria disappear from sputum, improvements in chest X-rays, and lung function. Participants will be followed closely for 12 months after starting treatment. Participants aged 12 to 65 with confirmed pulmonary TB will have multiple assessments including sputum tests, blood tests, lung function and chest X-rays at various points during and after treatment. Researchers will monitor safety by recording any serious side effects and will measure treatment effectiveness by the time to stable bacterial clearance and disease-free survival at six months. This extended follow-up aims to provide detailed data to support future larger trials.

Researchers are evaluating the pharmacokinetics and pharmacodynamics of atorvastatin at different doses combined with standard first-line treatment for adults with drug-sensitive pulmonary tuberculosis. This sub-study of the ATORTUB trial aims to identify an optimal atorvastatin dosing regimen to support pulmonary tuberculosis treatment. The study is a Phase 2 pharmacokinetics-pharmacodynamics dose-finding trial involving adults aged 12 years and older. Participants will be randomly assigned to one of four groups. All will receive the standard tuberculosis treatment regimen of rifampin, isoniazid, pyrazinamide, and ethambutol for 8 weeks followed by rifampin and isoniazid for 16 weeks. Additionally, three groups will receive daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The total treatment duration is 24 weeks, followed by a 6-month follow-up period, making total participation last 52 weeks. Throughout the study, participants will attend multiple visits for sputum collection, chest X-rays, lung function tests, and blood sampling to measure pharmacokinetic parameters of atorvastatin and the anti-TB drugs. Blood samples will be taken on day 14 and weeks 8, 16, and 24 after randomization to assess drug concentrations and metabolism. Researchers will monitor safety, treatment adherence, and lung health, with data used to develop a pharmacokinetic/pharmacodynamic model for future dosing recommendations.

Researchers are working to increase the number of healthcare providers skilled in colonoscopy in Nigeria to improve screening and early diagnosis of colorectal cancer (CRC). This project includes a needs assessment, simulation training using different types of colonoscopy models, and hands-on training with live patients. The aim is to expand the workforce capable of performing colonoscopy in a resource-limited setting like Nigeria. The study has three parts: first, surveys and interviews assess how many providers and facilities currently offer colonoscopy and what barriers exist. Geographic information system (GIS) technology helps analyze patient access to these facilities. Second, participants are randomly assigned to train on either a high-fidelity or a locally made low-fidelity colonoscopy simulator. Both groups receive identical lecture-based teaching adapted to the Nigerian context and practice colonoscopy on their assigned models with instructor feedback. Third, the following day, participants perform colonoscopies on live patients under supervision, with safety measures in place. Participants complete pre- and post-training assessments of colonoscopy skills and confidence using validated tools. Their performance on live patients is evaluated on multiple technical measures such as procedure time, cecal intubation success, and avoidance of complications. Patients consent to have trainees perform their colonoscopy under expert supervision. Participants also fill out satisfaction and confidence surveys. The primary outcome compares skill improvement between the low- and high-fidelity simulator groups five days post-training.

Researchers are conducting a case-control study in Nigeria to identify modifiable risk factors for breast and colorectal cancer. The study aims to understand how factors such as diet, physical activity, past medical history, and lifestyle may influence cancer risk. This study will recruit about 400 patients with a confirmed or new diagnosis of colorectal or breast cancer and 400 control participants without cancer or gastrointestinal diseases. Participants will complete a detailed questionnaire covering diet, physical activity, medical history, and lifestyle habits. Additionally, all participants will undergo body composition analysis using a bioimpedance machine that measures body mass index, fat percentage, and total body water. This information will contribute to identifying novel risk factors for these cancers within the Nigerian population. Throughout the two-year study, researchers will collect and validate questionnaire data and body composition measurements from both cases and controls. The main outcomes measured include the development and validation of a risk factor questionnaire specific to sub-Saharan Africa and the determination of new modifiable cancer risk factors. This study involves no treatment interventions but focuses on detailed assessments and comparisons between affected and unaffected individuals.

Researchers are evaluating the impact of a structured financial navigation program on reducing financial catastrophe and financial distress among cancer patients in Nigeria. This trial focuses on individuals newly diagnosed with breast, colorectal, or prostate cancer at two cancer centers in Lagos. The study aims to determine whether this program can effectively lower financial burdens and if it is financially sustainable for cancer centers in Nigeria, a country with a high cancer burden and significant poverty where many patients face overwhelming health costs. The study involves hiring salaried financial navigators who will educate patients about financial literacy, insurance options, and charitable assistance programs. These navigators will also verify insurance documents, maintain financial records, and coordinate payments with insurers. Participants will be randomly assigned to either receive this financial navigation program or not, allowing researchers to compare outcomes between groups. Participants will complete surveys about their demographics, clinical history, socioeconomic status, quality of life, and psychological wellbeing. They will report all cancer care-related costs. Researchers will monitor the incidence of financial catastrophe over 12 months and financial distress at 3, 6, and 12 months. Additionally, the study will analyze the cost-effectiveness and sustainability of the financial navigation program. The total follow-up period for measuring outcomes is up to one year after enrollment.

Triple negative breast cancer (TNBC) is an aggressive form of breast cancer that affects a higher proportion of Black women and younger age groups. Unlike other breast cancer types, TNBC lacks targeted therapies, so chemotherapy remains the main treatment option, although resistance often develops quickly. This phase II single-arm study aims to evaluate the response rate and side effects of standard chemotherapy using Epirubicin, Cyclophosphamide, Paclitaxel, and Carboplatin in Nigerian women with TNBC. The study also investigates whether changes in blood levels of microRNA molecules and circulating tumor DNA can indicate chemotherapy resistance or disease relapse. Participants will receive four cycles of Epirubicin and Cyclophosphamide every three weeks, followed by four cycles of Paclitaxel and Carboplatin every three weeks, over a total treatment period of about 4 to 6 months. Blood samples will be collected before and after therapy to measure microRNA and tumor DNA levels. Tumor response will be monitored using breast ultrasound and assessed with RECIST criteria, while toxicity will be evaluated using CTCAE version 5. The quality of life of participants during chemotherapy will also be assessed using a specific questionnaire. Throughout the study, researchers will track the number of participants achieving complete tumor response at surgery, which will take place within 4 to 6 weeks after chemotherapy ends. They will also monitor treatment-related side effects from the start of chemotherapy up to 60 months or until withdrawal or death. Participants will undergo regular blood tests, imaging, and quality of life assessments to evaluate treatment effects and safety over time. The trial follows international good clinical practice guidelines and plans to enroll 42 women aged 18 to 70 with confirmed TNBC.

Researchers are evaluating the effects of pre-operative chlorhexidine mouthwash and perioperative oxygen levels on the rates of pneumonia and surgical site infections in patients undergoing major abdominal surgery. This Phase 3, multi-center, randomized controlled trial is conducted across hospitals in low and middle-income countries, focusing on adults and children aged 10 years or older having elective or emergency midline laparotomy. The study aims to reduce serious postoperative complications that significantly contribute to mortality and healthcare burden, especially in these resource-limited settings. Participants will be randomly assigned to one of four groups combining the use or non-use of chlorhexidine mouthwash before surgery and different oxygen concentrations during surgery: (a) mouthwash with high oxygen (80-100% FiO2), (b) no mouthwash with high oxygen, (c) mouthwash with low oxygen (21-30% FiO2), or (d) no mouthwash with low oxygen. The trial includes a 6-month internal pilot phase to assess recruitment and compliance, followed by a main phase enrolling approximately 12,924 participants. During the study, researchers will monitor participants for pneumonia and surgical site infections within 30 days after surgery using CDC definitions. Data on treatment adherence and participant outcomes will be collected and assessed by blinded outcome assessors. The study will track complications and follow patients through their recovery to evaluate how these interventions might reduce postoperative infections and improve surgical outcomes.

Researchers are conducting a Phase III international study to evaluate whether an intravenous lidocaine infusion during breast cancer surgery can reduce the development of persistent pain three months after surgery. This trial includes patients undergoing lumpectomy or mastectomy, including prophylactic surgeries, to better understand ways to prevent long-term pain following breast cancer treatment. Participants are randomly assigned to receive either an intravenous lidocaine infusion or a placebo saline infusion during surgery. The lidocaine group receives a 1.5 mg/kg bolus at anesthesia induction followed by a continuous 2.0 mg/kg/hour infusion until the end of surgery and up to 30 minutes in the recovery room. The control group receives a saline solution following the same schedule. Both patients and researchers are blinded to the treatment allocation to ensure unbiased results. During the study, participants are monitored closely for the first three days after surgery and then followed up at three and twelve months. They report on pain levels, use of pain medications, and assessments of function, mood, and quality of life. The main outcome measured is the presence of persistent pain three months after surgery to determine if lidocaine can prevent chronic postoperative pain in breast cancer patients.

This research aims to find out if using intravenous prophylactic antibiotics and antimicrobial-coated sutures can reduce surgical site infections in children undergoing open groin surgeries such as for inguinal hernia or hydroceles. The study compares three groups: children receiving no antibiotics, children receiving intravenous prophylactic antibiotics, and children receiving antimicrobial-coated sutures. The goal is to determine which method, if any, lowers the risk of infection after surgery. Participants will be randomly assigned on the morning of surgery to one of three groups: Group A receives a placebo intravenous injection and non-coated sutures; Group B receives intravenous cefuroxime antibiotic and non-coated sutures; Group C receives a placebo intravenous injection and antimicrobial-coated sutures to close the surgical wound. The treatments are given at the start of anesthesia, and the sutures are used to close all layers of the surgical wound. After surgery, children will return for clinic visits on days 5, 13, and 30 to have their surgical wounds checked for signs of infection according to CDC guidelines. Researchers will monitor the rate of surgical site infection within 30 days after surgery to see if antibiotics or coated sutures help prevent infections. This is a double-blind, randomized controlled trial involving children up to 15 years old undergoing daycase open groin surgery.